WalkAide Syste Clinician Manual 2006 Innovative Neurotronics. All rights reserved. All tradearks and registered tradearks are the property of their respective holders. No part of this anual ay be reproduced in any for without the written consent of Innovative Neurotronics Incorporated. Inforation in this anual is for the use of qualified clinicians only. LM02-3 11/06 Caution: USA Federal Law restricts this device to sale by or on the order of a physician.
Table of Contents 1.0 Introduction 2 Indications of Use 4 Contraindications 4 Warnings about FES 4 WalkAide Specific Warnings 5 Precautions 6 Adverse Reactions 7 Cautions 7 Glossary 8/9 2.0 Equipent 10 2.1 Clinician Kit 10 2.2 Patient Kit 10 2.3 Sybols and Definitions 11 2.4 WalkAide Controls and Indicators 12 2.5 WalkLink Controls and Indicators 13 3.0 Installation of the WalkAnalyst Progra Fro CD 14 4.0 Set-Up Procedures for WalkLink 14 4.1 WalkLink Troubleshooting 17 0086 EC REP Medical Device & QA Services 76, Stockport Road WA15 7SN United Kingdo e-ail: info@dqa.co.uk 5.0 Overview of Data Collection Process 20 5.1 Set-Up Procedures for a New User 21 5.2 Collecting Initial Walking Data 25 5.3 Adjusting the User s Paraeters 31 5.4 Manual Adjustents of the Stiulation Paraeters 35 5.5 Exercise Settings 40 5.6 Usage Log 42 5.7 Additional Inforation 46 6.0 Use and Care of the WalkAide and Accessories 47 7.0 Troubleshooting 48 8.0 WalkAide User Manual 50 9.0 Technical Inforation 50
1.0 Introduction The WalkAide produces dorsiflexion of the ankle during the swing phase of gait. This sall device attaches to the leg, just below the knee, near the head of the fibula. During a gait cycle, the WalkAide stiulates the coon peroneal nerve, which innervates the tibialis anterior and other uscles that produce dorsiflexion of the ankle. Users of the WalkAide are people who have lost the ability to voluntarily lift their foot, often as a result of daage to the central nervous syste such as stroke, spinal cord injury, trauatic brain injury and ultiple sclerosis. This type of stiulation will not work with people who have daage to the lower otor neurons/peripheral nerves. 1. Clinician Heel Sensor is worn in shoe by user. 3. Clinician adjusts gait with anual STIM button on the WalkLink. The WalkAide is a battery-operated, single-channel electrical stiulator that can be used for functional electrical stiulation. It utilizes a Tilt Sensor to control stiulation during noral gait. A Hand Switch on the WalkLink is used by the clinician during set-up to trigger stiulation while the Heel Sensor collects additional data (Figure 1). The clinician uses the WalkAnalyst software on a laptop coputer to progra the Tilt Sensor in the WalkAide. Use of the Tilt Sensor to trigger stiulation eliinates the need for wires fro a Heel Sensor during regular use. 4. Notebook, desktop, or tablet PC collects Heel Sensor and STIM data for clinician. 2. User walks figure-8 with WalkAide and WalkLink attached. Figure 1: Initial WalkAide Set-up Procedure using WalkLink, Heel Sensor, and WalkAnalyst 2
Indications of Use The Innovative Neurotronics WalkAide Syste is intended to address foot drop in patients who have sustained daage to upper otor neurons or pathways to the spinal cord. During the swing phase of walking, the WalkAide electrically stiulates the appropriate uscles that cause ankle dorsiflexion and ay thus iprove the user s walking ability. Medical benefits of Functional Electrical Stiulation (FES) ay include prevention of uscle disuse or weakness, increased local blood flow, uscle strengthening, and aintained or increased joint range of otion. Contraindications Do not use on persons with iplanted deand type cardiac paceakers or defibrillators. Do not place the electrodes in the carotid sinus region (throat). Laryngeal or pharyngeal spass ay occur when the electrodes are placed across the throat or in the outh. Do not place the electrodes over alignant tuors. Do not place the electrodes over areas in which syptos of existing throbosis are present. Do not use if person has a history of seizure disorder. Warnings About FES Monitoring Equipent The use of FES ay interfere with the proper functioning of electronic onitoring equipent such as EKG achines. However, the operation of the FES device will not be affected by the use of electronic onitoring equipent. Electrodes The use of electrodes not supplied by Innovative Neurotronics ay diinish results or increase risk of burns or discofort. Do not place electrodes over open wounds, broken skin or etal objects beneath the skin such as surgical staples. Pregnancy The safety of FES for use during pregnancy has not been established. Hospital Equipent Do not use siultaneously with high frequency hospital equipent (e.g. diathery equipent). It ay result in burns at the site of the stiulator electrodes and possible daage to the stiulator. Skin Irritation Iproper or prolonged use of electrodes ay result in increased risk of skin irritation or burns and decreased effectiveness. Infrequently, there is an allergic response to the electrode adhesive or gel. Do not place electrodes on skin which is already irritated as this will increase the risk of discofort with stiulation or skin burns. Medical Supervision FES should only be used under the edical supervision of a physician and a qualified clinician. Two-Way Radios Care should be taken while using FES therapy in close proxiity (e.g. less than 1 eter) to devices which eit radio frequencies such as cellular phones or two-way radios as soe types of transitters ay cause undesirable stiulation to the user. Defibrillator External defibrillation of a person wearing a FES device can daage the device or injure the user even when the device is turned off. Under soe circustances there ay be risk of burns under the electrode sites during defibrillation. To eliinate any risk, the FES electrodes should be reoved before defibrillation paddles are applied. Chronic Stiulation Effects of long ter chronic stiulation are unknown in this particular application. WalkAide Specific Warnings Walking Care should be taken when using the WalkAide for people who experience dizziness or have difficulty aintaining balance. The WalkAide is not designed to prevent falling. Assess user s condition for inability to walk or balance. Electrodes The user should not relocate the position of the electrodes within the cuff. Do not use the WalkAide without electrodes. Placeent Never use the WalkAide on any area of the body other than the leg. Stiulation Stop using the WalkAide if stiulation does not coe on at the appropriate tie when walking and/or there is a change in the sensation perceived while the stiulation is on. Environent WalkAide and WalkLink are not intended for use within flaable environents such as oxygen and anesthetics. WalkLink 1. FCC Part 15 notice: This device coplies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device ay not cause harful interference, and (2) this device ust accept any interference received, including interference that ay cause undesired operation. 2. FCC Radiation Exposure Stateeent for Portable Devices This equipent coplies with FCC radiation exposure liits set forth for an uncontrolled environent. This equipent is in direct contact with the body of the user under noral operating conditions. This transitter ust not be co-located or operating in conjuction with any other antenna or transitter. 3. The user is cautioned that changes or odifications not expressly approved by the party 4 responsible for copliance could void the user s authority to operate the equipent. 5
Precautions Heart Disease Use caution in applying electrical stiulation to persons suspected of having heart disease. More clinical data is needed to show that such persons will not experience adverse results. Sensory Deprivation Use caution when placing electrodes on areas of the skin with reduced response to noral sensory stiuli, due to the risk of skin burns. Children FES devices should be kept out of the reach of children. Epilepsy Use caution in applying electrical stiulation to persons suspected of having epilepsy. More clinical data is needed to show that such a person will not experience adverse events. Recent Surgery Do not use FES following recent surgery where uscle contraction ay disrupt the healing process. Electrodes Do not use lotion or oil in the area that the electrodes ake contact with the skin. Stiulation ay not be effective. Proper Use The safety and efficacy of FES depends on the proper use and handling of the FES syste. Iproper use of the device or electrodes can result in injury to the user. Regularly check accessories for wear and replace as needed. Electrodes should be firly secured to the skin. Never use the WalkAide if it appears to be alfunctioning. If there is a change in the way it usually works (i.e. change in sensation, surging of stiulation, interittent stiulation) do not use the WalkAide and contact Innovative Neurotronics iediately. Operating Equipent The stiulator should not be used while operating potentially dangerous equipent such as autoobiles, power lawn owers or large achinery. Abrupt changes in stiulation level could create a hazard. Sleeping The WalkAide should not be worn or used while sleeping or bathing. Heat and Cold The use of heat or cold producing devices such as electric blankets, heating pads or ice packs ay affect the electrodes or the person s circulation and increase the risk of injury. A edical doctor and clinician should be consulted before using with FES. Adverse Reactions Skin irritation and burns beneath the electrodes have been reported with the use of powered uscle stiulators. Do not leave the electrodes in place for long periods of tie without checking or cleaning the skin underneath the. It is noral to observe soewhat reddened areas under the electrode placeents; however, the redness should disappear within an hour. Signs of irritation are aintained redness, sall piple-like lesions or blisters. DO NOT continue stiulation over irritated skin. Notify the edical doctor if these conditions persist and discontinue use of the WalkAide until the proble is resolved. Cautions Functional electrical stiulation (FES) is the process of using electrical stiulation to activate uscles. Basic rules of FES use include: 1. ALWAYS use the WalkAide under the specific instruction of an experienced clinician. 2. NEVER use the WalkAide in a situation where an unexpected or unusual stiulus ay occur, such as driving or operating otorized equipent. 3. DO NOT use the WalkAide if the equipent is not operating properly. 4. NEVER use the WalkAide unit with frayed or broken leads. 5. ALWAYS handle the unit carefully do not expose the unit to water, excessive heat or vibration. 6. DO NOT place electrodes anywhere other than on one leg below the knee. 7. AVOID dropping the WalkAide unit. Although robustly designed, daage ay occur that could cause the unit to alfunction. 8. The WalkAide should ONLY be used with approved accessories and electrodes. 9. DO NOT open the unit other than to replace the battery. The WalkAide has no user or clinician serviceable parts inside the control odule enclosure. 10. Turn off the unit if sitting for an extended period of tie. 6 7
Glossary Ter Definition Ter Definition Associated Paraeters Paraeters that are associated or derived fro the WalkAide control odule during data collection and analysis. Peripheral Nerve Stiulator Allows accurate location of peripheral nerves, specifically the coon peroneal nerve, for application of electrodes. Autoset Paraeters Cuff Exercise Mode Functional Electrical Stiulation (FES) Hand Switch This process attepts to adjust the threshold settings to ore closely atch the actual data collected. Plastic insert with fabric cover that attaches to the leg and is used to hold the electrodes and the WalkAide control odule in the correct position. Allows the user to repeatedly stiulate the dorsiflexors of the foot while resting (NOT walking) for a set period of tie as deterined by the clinician. Using sall electrical ipulses to activate dysfunctional uscles and produce intentional and useful oveent. A function of the WalkLink whereby pressing the STIM button on the WalkLink sends a coand to the WalkAide control odule to provide stiulation. Retrieve Paraeters Send to WalkAide STIM WalkAide WalkAnalyst Allows the clinician to obtain paraeters fro the WalkAide control odule using the WalkAnalyst software. Allows the clinician to send paraeters to the WalkAide control odule using the WalkAnalyst software. Abbreviated for of the word stiulation. A battery-operated, single channel electrical stiulator that can be used for both therapeutic and functional electrical stiulation. Software used by the clinician to interface with the WalkAide control odule. This allows data collection, analysis and paraeter odification in order to correctly tie applied stiulation to the user. Heel and Foot Sensors There are two types of sensors: (1) The clinician Heel Sensor is used while testing a potential WalkAide user during data collection and analysis. (2) The optional Foot Sensor is sent hoe with users whose gait pattern does not provide sufficient tilt inforation to reliably trigger the stiulation. WalkLink Zoo Feature Provides wireless connection between WalkAide and coputer, and also allows anual stiulation during walking trials via Hand Switch. Allows clinician to focus on specific data by highlighting it with the stylus or ouse. Optiize Paraeters Function of the WalkAnalyst software that coputes features of the collected data and attepts to configure the ON and OFF thresholds and other paraeters to optiize the user s gait. 8 9
2.0 Equipent 2.3 Sybols and Definitions 2.1 Clinician Kit The Clinician Kit consists of the WalkLink, WalkLink cable, Heel Sensor, and the WalkAnalyst software. The clinician is recoended to have a coputer that eets or exceeds the following requireents: l Windows XP Professional with SP2 or better l 256 MB of RAM l 1.5 GHz processor or better l Bluetooth Connectivity Slot-USB Port l Graphic display with iniu resolution of 1024 x 768 and video display setting set to 96 DPI l 150 MB of free space 2.2 Patient Kit The Patient Kit consists of the WalkAide Control Module, WalkAide Electrode Lead Cable, WalkAide Electrodes (pkg. of 4), WalkAide Cuff, and Foot Sensor (optional ite). (Figure 2) Meaning of Sybols Attention, consult accopanying docuents Type BF Equipent Indicates Error Signal Indicates battery location and positioning Indicates ipulse, STIM button Indicates connector location for Clinician Heel Sensor and optional Patient Foot Sensor Indicates input/output connector location for WalkLink Indicates exercise button Ionizing radiation The WalkAide requires a single AA battery and the WalkLink requires four (4) AA batteries to operate. Only AA alkaline (1.5 V) batteries should be used and extra batteries should always be available during follow-up appointents. Figure 2: WalkAide Patient Kit 10 11
2.4 WalkAide Controls and Indicators 2.5 WalkLink Controls and Indicators Red visual indicator for error and low battery voltage (4) Exercise Button (3) Green blinking light indicates that power is on with adequate battery power (2) Power Indicator Aber blinking light indicates the presence of STIM (5) STIM Button (6) Intensity Knob (1) Figure 3: Top view of WalkAide unit Unpair button Bluetooth Connection Indicator Low Battery Indicator WalkLink STIM button (Hand Switch) Audible Alars: 1. Low Battery: An audible alar every inute with red blinking light. 2. Heel/Foot Sensor: An audible alar of two beeps every two seconds indicates that Heel/Foot Sensor is not connected, if it is configured for the Heel/Foot Sensor. 3. Device Error: An audible alar of 4 beeps every 2 seconds. Figure 5: Front and side views of WalkLink unit Output Connector for Electrode Lead Cable (7) Heel or Foot Sensor Connector [if provided to user] (8) Battery Copartent for standard AA Alkaline battery (9) WalkLink Connector [for clinician use only] (10) Back Left side Front Right side Figure 4: Back, side(s) and front view of WalkAide unit 12 13
3.0 Installation of the WalkAnalyst Progra fro CD (This only needs to be installed once in order to run this progra. Installation will be perfored during the training course or provided on CD.) 1. Insert the CD WalkAnalyst Progra in the appropriate drive. The tablet PC ay have an external CD drive. Make sure it is properly connected and operating correctly prior to inserting the WalkAnalyst CD. 2. The CD should autoatically start the installation progra. Follow the set up instructions that will appear. 3. If the CD does not autoatically start the installation progra, find the appropriate drive icon and open the folder. Double click on the Setup.exe file. Follow the set up instructions that will appear. 4. The WalkAnalyst progra will be installed in the Progra Files/Innovative Neurotronics directory unless another directory is selected. 5. Once the progra has been installed, an icon will be created on the desktop for quick access. WalkAnalyst can also be accessed fro the Windows start enu. 4.0 Set-Up Procedures for WalkLink If you have not copleted the initial setup process: You will need to create a link fro your coputer to the WalkLink. The following guideline will show you how this is accoplished. Below are the typical steps required to set up your hardware. You will be guided step-by-step through the process. Should you encounter probles, please refer to the troubleshooting guide for possible issues and resolution options. 1. Install WalkAnalyst: Fro section 3.0, you should have already installed WalkAnalyst. In order to ensure the best possible Bluetooth connection experience, we require Windows XP Service Pack 2 or later. To support an eerging technology such as Bluetooth, we rely on the latest technology that Microsoft provides in order to liit installation frustrations. 2. Install the Bluetooth Adapter: Insert this device into a free USB port on your tablet, notebook or desktop personal coputer. The device should install itself, requiring no action on your part. You will receive a notification that new hardware was successfully installed. 3. Prepare the WalkLink Device: The WalkLink device has an ebedded Bluetooth transitter. Insert four new AA batteries in the device and turn on the power switch, located on one side. Just above the power switch, there is a recessed unpair button. To ensure that the device is ready for initial connection, take a ball point pen and depress this button, holding it down for three to four seconds, turn the power off, wait ten seconds and then turn it back on. This step ensures that the device is not connected to any other achine, as it will pair itself to yours when you coplete the installation. The WalkAide device sends real tie data to and receives paraeter changes fro the WalkAnalyst progra. In order to avoid connecting a physical cable to the patient, a wireless solution has been created eploying Bluetooth radio technology. This technology allows secure short-range counication between electronic devices. 4. Establish a Connection to the WalkLink Device: Start the WalkAnalyst software by double-clicking on the WalkAnalyst icon that should be present on your coputer s desktop. Alternatively, you can go to Start > Progras > Innovative Neurotronics > WalkAnalyst.. The first tie the software runs, it should propt you to run the Bluetooth Connection Wizard (Figure 6). If you have previously set up the link fro your coputer to the WalkLink: After the initial set up process is coplete, turn on the WalkLink prior to starting WalkAnalyst. The blue light on the front of the WalkLink should begin to blink and the progra should start norally. The WalkAide can be attached to the WalkLink at any tie. The yellow light bulb in the upper left hand corner of the WalkAnalyst interface will indicate that you Figure 6: Establishing a connection have a solid connection to the WalkAide. If you have the WalkLink device on and ready to be configured, press Yes. You will then be presented with the configuration wizard. (Figure 7) 14 15
4) Enter the WalkLink MAC Address: uch like a street address or telephone nuber, each WalkLink has an address that is used to ensure counication happens with only that device. You can find this address on the label located on the back of the device. Figure 7: WalkLink Configuration Wizard Following the steps of the wizard: 1) Turn on the WalkLink: If your WalkLink is on, the left hand LED on the face of the device should be flashing green, as in the following iage: Figure 10: WalkLink barcode label You need enter only the final three nubers in the address, as indicated by the red square in figure 10. 5) Connect: press the button labeled 5. Connect to WalkLink to initiate the connection process. The wizard will try to establish a connection to a WalkLink with the address you have specified. The wizard ay take a inute or ore to coplete this process. When finished, you should see a confiration essage. Press OK to launch WalkAnalyst. If everything has worked as expected, your WalkLink device should now have a blinking blue light. (Figure 11) Figure 8: Flashing green light indicates WalkLink is on 2) Unpair the WalkLink: Using the tip of a ballpoint pen, press and hold the unpair button for a few seconds. Unpair button Figure 11: Blue light indicates Bluetooth connection Your device is now connected. Under noral circustances there should be no reason for you to return to the wizard. If you need to ake adjustents in the future or the progra opens in Offline ode due to being unable to find your WalkLink device, you can choose the Configure option in the upper right corner of the hoe page of the WalkAnalyst progra which will provide you with several options, the ost coon of which will be to siply search for the WalkLink device again. (Figure 12) Figure 9: WalkLink unpair button 16 3) Reset the WalkLink: To reset the WalkLink, turn the power off and back on. Figure 12: Search for WalkLink 17
Section 1: Hardware: Belkin Device Proble 1: An error occurred while installing the progra If you did not see a confiration essage that your new hardware is installed and ready to use you ay need to follow the installation instructions that accopany the Belkin device. Proble 2: The Belkin device is not flashing a blue light A properly functioning Belkin device will flash a blue light to let you know it is working properly. If you do not see this, you ay want to try the device in a different USB port. During the search process, the blue light will blink rapidly, which is another sign to look for to ensure proper hardware functionality. It ay be possible that the Windows Bluetooth search ay yield results. Our software uses the sae internal coands that the Windows wizard does, but there ay be an internal setting to the WalkLink that does not atch our search paraeters. To test this, follow these steps: - Go to Start > Settings > Control Panel > Bluetooth Devices to start the search progra - Under the Devices tab, press the Add button - Ensure the WalkLink is on, check the My device is set up ad ready to be found and press the Next button. - If you see a device with the label WalkLink No 001, the Windows wizard has located the device. Cancel out of the wizard and return to WalkAnalyst and try again. If you have another USB device, such as a ouse or keyboard, that is functional, you ay wish to swap out teporarily the device with the Belkin device to see if the unit begins to function. Section 2: Hardware: WalkLink device Proble 1: The left-ost LED light does not flash a green light every two seconds The flashing green light is a power indicator. If it is not flashing, the device ay have siply tied out. Turn the device off for a few seconds, turn it on and see if the light begins to flash. Check and ake sure the batteries in the device are new. Do not rely on rechargeable batteries for the WalkLink. Proble 3: You have established a connection with the WalkLink device during installation but now you are seeing essages fro WalkAnalyst that WalkAnalyst could not find a configured WalkLink Turn the WalkLink off and back on and either choose the configuration button fro within the WalkAnalyst software (selecting the first option on the configuration dialog) or siply exit and restart the WalkAnalyst application. Ensure the green light is blinking every two seconds on the WalkLink device. The device will tieout after a period of tie if the WalkAnalyst software is not running and the blue light is blinking on the WalkLink device. Turn the device off for a few seconds, then turn it back on and restart the WalkAnalyst application. Proble 2: The device did not appear during the WalkAnalyst Bluetooth configuration process Turn the device off for five seconds and turn it back on and press search again. Are you using Windows XP Service Pack 2? This is required for the configuration search to execute. The WalkLink device ay need to be unpaired. Follow these steps: - Turn on the WalkLink device (confir the flashing green light). - Using a ballpoint pen or soething siilar, press and hold the sall unpair button above the on/off switch for five seconds. - Turn off the device, wait five seconds, and then turn on the device and try the search process again. One thing to recognize in this situation is that unless soething else has changed in your coputer configuration, there is no reason to run the full Bluetooth configuration wizard again. Once WalkAnalyst has successfully connected one tie, you should be able to start the progra without any changes to your hardware settings. Proble 4: When the WalkAnalyst software progra starts the startup screen states that the software could not find a WalkLink Receiving an iediate essage that no device was found ay indicate a teporary proble with Windows. You ay wish to restart your coputer to see if the proble goes away. A noral setup will search for five or ore seconds for a device before returning a essage that the device was not found. Please do not confuse this essage with the initial essage that coes up the first tie the software is installed, which iediately tells you that the Ensure the device is on and search for the device at least five ties. configuration step has not been copleted. 18 Soeties the device shows up on later searches. 19
5.0 Overview of Data Collection Process 5.1 Set-Up Procedures for a New User Figure 13 outlines the process used to provide the WalkAide for a new user. Insert previously installed Belkin USB Bluetooth adapter into the personal coputer. Pre-test Activities Preparing User Begin User Set-up Prior to the user s arrival, turn on the WalkLink, start the WalkAnalyst progra and verify that the wireless connectivity (Bluetooth) is working correctly. 1. Have the user sit in a chair with the legs extended, resting affected leg on a low stool. Find User s Stiulation Points Attach Electrodes to cuff Attach Heel Sensor 2. Clean the skin in the area around the head of the fibula with soap and water and wipe dry. Failure to adequately prepare the skin ay cause iproper contact and provide less than ideal stiulation. 3. Use the peripheral nerve stiulator to find the appropriate stiulation site of the coon peroneal nerve which runs posterior to the head of the fibula (Figure 14). If the user is apprehensive about stiulation or there is soe concern if the nerve is functional or hypersensitive on the affected side, stiulation ay be applied on the unaffected side first. Test Stiulation Practice walks Record Walks Create Setup Post-Setup Tasks Disconnect Procedure Post-Setup Walk recordings Instruct User Figure 14: The peripheral nerve stiulator and the WalkAide stiulate the uscles that raise the foot Figure 13: Set up process for WalkAide 20 21
4. Make sure the WalkAide is turned OFF and attach it to the cuff on the edial flattened area. Position the cuff around the id-calf region and tighten the Velcro strap to hold it in place below the potential electrode sites. This places the cuff in a convenient location to hook up the electrodes. 5. Put a sall aount of water or gel on the electrodes and/or user s skin specifically in the area of electrode placeent. Place the back electrode slightly posterior to the head of the fibula and the front electrode on the upper 1/3 of the tibialis anterior uscle over its uscle belly (Figure 15). 8. Press down on the large black STIM button labeled for 1-2 seconds. An aber light next to the STIM button will appear to indicate that the unit is stiulating. Watch the ankle for dorsiflexion. Turn up the intensity if the oveent produced is too sall or ove the back electrode slightly to the rear and try again. Even a sall anterior shift of the electrode ay change the aplitude or direction of the foot oveent (for exaple, fro dorsiflexion to eversion with ore recruitent of the peroneals). The goal is to produce a relatively pure dorsiflexion with as low stiulus intensity as possible. Note the nuerical value of the intensity level used to produce an effective dorsiflexion oveent. 9. Once the optial electrode positions have been found, turn OFF the WalkAide and disconnect the Electrode Lead Cable fro the electrodes. 10. Release the Velcro strap and properly align the cuff over and around the pretibial region (i.e., line the center of the cuff with the anterior crest of the tibia and note the nuber of finger widths fro the top of the cuff to the base of the patella). Press over the electrodes to ensure that the Velcro backing adheres to the inside of the cuff. 11. Carefully reove the cuff with the electrodes that are now connected by Velcro to the inside of the cuff. Thread the leads fro the electrodes through the holes on the cuff. Connect the black lead (negative) to the back electrode and the red lead (positive) to the ore anterior electrode. Figure 15: Connecting the electrodes 6. Connect the electrodes to the WalkAide Electrode Lead Cable on the WalkAide. Make sure the BLACK lead (negative) is connected to the BACK electrode and the RED lead (positive) is connected to the FRONT electrode. NOTE: The plastic insert inside the cuff can be custo fitted to each individual. The length of the insert ay need to be tried if the user coplains of pinching at the back of the knee when sitting. The insert can also be heat olded to accoodate individual anatoical variations. 12. Place the electrode leads and connectors in the groove of the cuff and cover with the Velcro strap (Figure 16). 7. Turn the WalkAide ON by turning the blue Intensity Knob in a clockwise direction to the 1 (on) position. A green light will flash interittently to indicate that the unit is on. ALWAYS start at a low level of intensity and gradually increase. Figure 16: Electrode leads and connectors in channel 22 23
13. Replace the WalkAide unit and cuff in the correct position on the user s leg. (Figure 17) 14. Place a Heel Sensor (if desired) in the user s shoe on the affected side and connect its cable to the WalkAide unit. 5.2 Collecting Initial Walking Data 1. Double click the icon labeled WalkAnalyst on the coputer desktop. The progra will open with the Hoe screen (Figure 18). A lightbulb icon in the upper left corner of the screen will appear yellow if the WalkAide and WalkLink are correctly connected and counicating with the coputer. Figure 17: Correct placeent of WalkAide 15. Connect the WalkLink Cable to the WalkLink unit and then to the WalkAide for the initial walking trial. The WalkLink allows the clinician to provide appropriate stiulation to the foot fro heel-off to initial contact. (A lanyard is provided to allow the user to wear the WalkLink during later walking trials when the hand stiulation function is not needed by the clinician.) 16. Turn the WalkAide ON and adjust the intensity to the sae level deterined during initial fitting. Test the stiulation by holding the blue STIM button down for 1-2 seconds to ensure appropriate placeent of the electrodes and cuff prior to walking. Figure 18: Hoe screen 2. Click on New File and enter the Basic Inforation. Click the Save icon and accept or enter a new file nae. All files are saved, by default, to the My Docuents\WalkAide Patient Data\ folder (Figures 19 and 20). Once the electrode placeent as been finalized, trace around each electrode on the inside of the cuff with a Sharpie arker or equivalent. This should only be done after all adjustents and walking trials have been copleted. If a Foot Sensor is recoended for the user, the Foor Sensor should be tried to fit appropriately inside the shoe. Please take care not to daage the ebedded sensor or the attached wires. 24 25
3. Click Default Paraeters fro the list on the left (Figure 21). Check to see that the WalkAide Stiulation Mode is set to the appropriate setting (Hand) and then click on the Send to WalkAide icon. Click OK when the default paraeters have been successfully sent. If the clinician decides to set the WalkAide to use in the Heel Mode, the Heel or Foot Sensor ust be connected to the unit or a sharp beep will eanate two ties every two seconds. Figure 21: Default paraeters screen 4. Click on Collect Walking Data fro the list on the left of the screen (Figure 22). Figures 19 and 20: Basic inforation and Save screens a. Seven icons appear at the top of the screen. Fro left to right they represent Print, Main Menu, Save, WalkAide Help, WalkAide Configuration, Miniize and Exit. Figure 22: Collect Walking Data screen 26 27
5. Position the user at the top of the figure-8 walking pattern or hallway as shown in Figure 1. Make sure the cuff is properly positioned and there are no dangling cables that ight cause the user to trip or fall. Ask the user to stand, balance and prepare to walk. 6. Ask the user to begin walking and click on the icon labeled Start Collecting Walking Data. Walk beside user and press the STIM button on the WalkLink to activate ankle dorsiflexion during EACH step of the affected lib fro just after heel off to just after initial contact. It is very iportant to correctly tie the stiulus with each step to axiize function of the WalkAide. 7. Data fro the WalkAide will appear on the screen fro left to right in three panels. When the data fills the screen, the trace wraps around and begins again at the left edge. With notebook coputers the display of the data ay be delayed soewhat because LCD displays update slower. The data are stored in a buffer before being displayed, so no data are lost, even if the display is not quite in real tie. a. The top panel shows recording fro the Heel Sensor. The signal will be high when the heel is off the ground (terinal stance to initial contact) and low when the heel is on the ground (initial contact through terinal stance). b. The iddle panel shows the actual stiulations (represented by short vertical bars) applied to the WalkAide each tie the stiulation button on the WalkLink was pressed. Figure 23: Stop Collecting Walking Data screen 8. When a sufficient nuber of steps have been recorded, click on the Stop Collecting Walking Data button (Figure 23). (Typically, the user ight walk for 10-20 steps over a 30 second period of recording.) 9. Click on the Add Walking Data to List button in order to proceed with the analysis of the data (Figure 24). Each walking trial for this user will be labeled with a date and tie, with the Associated Paraeters listed underneath each trial. These files will be listed on the left side of the screen under Collect Walking Data. c. The botto panel shows data fro the Tilt Sensor. The signal will be high when the leg is behind the body (terinal stance to swing phase) and low when the leg is in front of the body (initial contact to idstance). Figure 24: Add Walking Data to List 28 29
10. Select the specific walking trial for further assessent by clicking on the appropriate date and tie label. Two siilar Heel and Tilt Sensor graphs are shown separated by an expanded panel. The panel contains up to 3 rows of sall interittent bars indicating the tiing and ethod used to trigger the stiuli. The top (red) row represents the tiing of the Heel Sensor stiuli (when used) and the iddle gray row represents the actual stiulations produced by whatever ethod was used to produce the stiuli (Heel Sensor, Hand Switch or Tilt Sensor). 5.3 Adjusting the Users Paraeters 1. Click the Autoset Paraeters button to autoatically odify the paraeter settings based on statistically calculated values fro the recorded heel (if used) and tilt data (Figure 25). Click OK to accept the statistical calculations and standard deviations when the paraeter adjustents have been copleted. 11. The data analysis page displays the collected data points and color codes these points to indicate when the device would be in STIM ode given the associated paraeter settings. When the graph points are colored green, the device would be delivering stiulation. As paraeter adjustents are ade, the stiulation initiation and terination points are altered to reflect the changes. 12. The goal of data analysis is to align the Tilt Sensor stiulations to either the Hand Switch or the Heel Sensor stiulations. This is achieved by altering the paraeters using the Autoset Paraeters, Optiize Paraeters, and/or anually adjusting the paraeters. a. If only two inputs were used (for exaple the Tilt Sensor and the Hand Switch on the WalkLink), the goal is to atch the Tilt Sensor stiuli pattern to the actual stiulations delivered by the Hand Switch. b. Note that users whose walking pattern does not activate the Tilt Sensor (i.e. insufficient hip or knee flexion/extension) will need to use the Heel Sensor for initial set up and then be provided with the Foot Sensor for safe walking. Figure 25: Autoset Paraeters 2. Click the Optiize Paraeters button. Choose the desired reference signal (i.e. Heel or Hand) and the signal to be optiized (i.e. Tilt or Heel) and press the Start Coputation button (Figure 26). This process takes a few seconds and will autoatically odify the thresholds and tie(s) in the tilt data to best atch the desired reference signal. a. Either Accept Changes or Cancel the calculated fit paraeters depending on the Error %. If the error percentage is greater than 20, cancel the optiization. Manual adjustent of the paraeters will be required. b. Use both the Autoset Paraeters and Optiize Paraeters functions on a new set-up procedure. Use only the Optiize Paraeters function on follow-up visits for an existing WalkAide user. 30 31
4. Clicking in the iddle panel will produce a vertical cursor that can be dragged while the ouse button is down and can be used to check alignent of displayed events. For exaple, the light blue stiulation bars for the tilt data will be slightly offset fro the heel data as dorsiflexion should be initiated just after heel off and should be discontinued just after initial contact. Click the Reset Zoo button to return to the original data. Figure 26: Optiize Paraeters screen 3. A subset of the collected data ay be selected for analysis by clicking in either the Heel or Tilt Sensor window and dragging the cursor over the good data. The selected data will be highlighted in a lighter color (Figure 27). If selected first, the Autoset Paraeters and Optiize Paraeters buttons will set paraeters based only on the selected data. (This ay be appropriate for a user with liited walking abilities or an inconsistent walking trial that could not be repeated.) 5. If the data set is relatively clean (i.e., no issed steps), the stiuli produced using both Tilt and Heel Sensors and their odified paraeters will ore or less line up with those actually delivered by the Hand Switch. Check in particular that there are few extra stiuli (extra light blue bars in the odified lines) or issed stiuli (absent light blue bars in the odified lines). If the fit is good, save the data in the user s file by clicking on the Save icon and naing the file or allowing it to overwrite the original file. a. The Adjust Min Tie, Adjust Max Tie and Adjust Wait Tie sliders are located at the botto of the screen and allow fine-tuning of paraeters. These control ties are discussed below. 6. NOTE: The original data can be restored at any point to return to the paraeter settings under which the data were collected. Click on Restore Original Paraeters on the data analysis screen or Restore on the Associated Paraeters screen. Figure 27: Zoo screen Figure 28: Associated Paraeters screen 32 33
7. Click on the Associated Paraeters for the selected trial fro the list on left side of the screen (Figure 28). Set the WalkAide Stiulation Mode to the appropriate setting (Tilt or Heel) and click on the Send to WalkAide icon. Click OK to confir. The new paraeters associated with the user s previous walking trial have now been sent to the WalkAide. 8. Click Add to List to store the final adjustents under Device Paraeters at the left of the screen. 9. Turn OFF the WalkAide and disconnect the WalkLink. Turn ON the WalkAide and ask the user to walk again to verify that appropriate stiulation pattern produces safe and effective walking. The Heel Sensor ay also be reoved or left in the shoe for further use. 5.4 Manual Adjustent of the Stiulation Paraeters Manual adjustent of the paraeters can be perfored by adjusting thresholds and associated paraeters. This process relies on the clinical judgent of the treating clinician. ONLY use the anual adjustent feature if the pattern of stiulation is NOT copletely satisfactory after applying the Autoset Paraeters and Optiize Paraeters options. Again, all data for any walking trial can be restored to the original state by clicking the Restore option. 10. If both the clinician and the user feel that the tiing of the stiuli is reliable and useful, then the WalkAide can be sent hoe with the user. It ay also be helpful to test the WalkAide on a variety of surfaces (e.g., linoleu, carpets, raps and stairs, etc.) before aking this decision. If the stiuli are not reliable or helpful, the paraeters can be further odified as described in the next section. 11. The user s data file should be saved after every data collection procedure to avoid accidental data loss. The data can always be reoved later by using the Delete Data option. 12. For reference, the WalkAide device serial nuber will be autoatically logged and noted in the Associated Paraeters screen. Figure 29: Adjusting the On and Off thresholds Fro the Graphs screen: 1. The On and Off thresholds of the Heel and Tilt Sensors trigger the tiing of the initiation and terination of the stiuli (Figure 29). a. Stiulation occurs when the sensor value reaches the On threshold. - The On threshold (solid green line) ay be too high and the sensor value never reaches it. If this appears to be the proble, lower the threshold by clicking on the green line with the left ouse button and dragging it lower. When the button is released, the odified pattern of stiulation is calculated and displayed. b. Stiulation terinates when the sensor value reaches the Off threshold. - The Off threshold (solid orange line) ay be too low. The value of the sensor ust go below this line after one stiulus is coplete to allow another stiulus to be generated. If this appears to be the proble, raise the threshold by clicking on the orange line and dragging it up. c. The reason for having an Off threshold as well as an On threshold is to prevent extra, unwanted stiuli, but the difference between the two 34 levels ay be too great depending on the quality of the user s gait. 35
2. The Wait Tie is a specific period of tie after each stiulus before a new stiulus can be initiated. a. The Wait Tie ay be too long. To avoid the subject getting stiuli too close together, there is a iniu tie, known as the Wait Tie, after each stiulus, before a new stiulus can be initiated. To see if this is the proble, click and drag the slider in the Wait Tie display in the lower right hand part of the screen. Observe the changes in the alignent of the stiulation bars. The Wait Tie decreases (or increases) in increents of 0.1sec. (This paraeter can also be adjusted fro the Associated Paraeters screen.) 3. The Min Tie sets the iniu period of stiulation that is allowed. (The Min Tie always overrides the Max Tie.) The Min Tie ensures that stiulation continues for a sufficient duration that the toe clears the ground during swing phase. If the data fro the sensor are noisy, values ay occasionally exceed the On Threshold and then shortly thereafter go below the Off Threshold. That will turn off the stiulus after a period of tie that is too sall to be effective. To see if this is the proble, click and drag the slider in the Adjust Min Tie display. The values again increase (or decrease) in increents of 0.1 sec. (This paraeter can also be adjusted fro the Associated Paraeters screen.) 4. The Max Tie sets the axiu period of stiulation that is allowed. For exaple, if the user sits down and unloads the Heel Sensor, the stiulus will be discontinued after the value set in Max Tie has been reached. If during walking there are periods of stiulation that are particularly long, the Adjust Max Tie can be decreased to reduce the period of stiulation. (This paraeter can also be adjusted fro the Associated Paraeters screen.) Fro the Associated Paraeters screen: 1. Thresholds The thresholds can be best adjusted on the Graphs screen by oving the solid green (On) and solid orange (Off) lines to best capture the peaks and valleys of the stiuli. The threshold values will be autoatically transferred to the Associated Paraeters screen. a. Heel On b. Heel Off c. Tilt On d. Tilt Off 2. Exercise Settings Discussed in detail below. 3. Filter Paraeter (Figure 30) a. If the sensor signal is quite noisy (variable) so stiulation is unreliable; the Filter Setting can be increased. This will sooth any new data that are collected but will have no ipact on any previously collected data. Increasing the filtering (soothing) introduces soe delays. Alternatively, if an earlier stiulus is desired and the data are not very noisy, the filtering ay be decreased. The default setting is 4. 5. If there are extra periods of stiulation (ore than one period per step cycle) this could also be due to several factors: a. The On Threshold ay be too low (and too quickly reached). b. The Off Threshold ay be too high (and too easily reached). c. The Min Tie ay be too short. d. The Wait Tie ay be too short. Figure 30: Filter Paraeter 36 37
4. Stiulus Paraeters These adjust the characteristics of the pulses within the train. (Figure 31) 5. Control Ties These adjust the characteristics of the pulse train (Figure 32). Figure 31: Stiulus Paraeters a. The Pulse Width is the duration of each stiulation within the pulse train and can be increased if the user s foot is not dorsiflexing quickly or strongly enough. Increase the Pulse Width to allow a lower stiulation intensity level to be used by the user. Decrease the Pulse Width if stiulation is uncofortable even at lower stiulation intensity levels. b. The Tie Between (s) stiuli is inversely proportional to the stiulus rate. A tie of 50 s represents a rate of 1 stiulus every 0.05 seconds, or 20 stiuli per second. The longer the tie in between, the lower the rate. The goal is to have the lowest possible rate to iniize uscle fatigue while still having a sooth contraction. 40 s (25 stiuli per second) is the default value. Decrease the Tie Between (s) to provide a ore forceful and faster stiulation. Increase the Tie Between (s) to provide a less forceful and gradual stiulation. The Min Tie, Max Tie and Wait Tie are best adjusted on the Graphs screen by oving the appropriate sliders to have a good, regular pattern of stiulation. The values of these Ties are autoatically transferred to the Associated Paraeter Screen. a. Min Tie b. Max Tie c. Wait Tie Figure 32: Control ties c. The Extra Stiuli feature is essential when a quick start to otion is required. The extra stiuli will provide a faster increase in uscle force at the onset of stiulation (after the first and second pulses). This ay be helpful for user s with faster walking speeds. 38 39
d. The On Rap Tie (sec) controls the rate of onset or the rise of the initial stiulation level fro zero to its set value. Use this to increase or decrease the rate of dorsiflexion of the foot after terinal stance. Increasing the tie for raping on the stiulation will result in ore gradual dorsiflexion and ay be helpful for users with clonus or spasticity. e. The Off Rap Tie (sec) controls the rate of the fall of the stiulation fro its set value to zero. Use this to control foot slap or the rate of plantarflexion during initial contact. Increasing the tie for raping off will result in ore gradual plantarflexion. Once the new paraeters and the ethod of stiulation (e.g., Heel or Tilt) are selected, click on Send to WalkAide icon. Always check Device Paraeters after sending updated values. This will ensure that the values in the WalkAide have been odified and will be saved in the user s folder. The updated paraeters can then be tested with the user and new data can be collected for further analysis. 5.5 Exercise Settings 1. First, click on Paraeters fro the list on the left side of the screen (Figure 33). 2. Click on Device Paraeters to retrieve the current settings. Click OK once paraeters have been retrieved. 3. The exercise paraeters ay be adjusted for the user and sent to the WalkAide by clicking on the Send to WalkAide button. A confiration essage will appear once the data has been successfully sent. Figure 33: Exercise Settings 4. Under Exercise Settings, use the ouse to drag the scroll bar in order to adjust the On Tie, Off Tie and Duration that are suitable for the user. 5. The paraeter ranges are as follows: On Tie: 1-5 seconds, Off Tie: 1-10 seconds, exercise Duration: 1-30 inutes. 6. Click Send to WalkAide in order to store the new paraeters in the WalkAide unit. It is also a good idea to save the odified paraeter file for future reference. Once seated with the leg supported and the stiulus intensity low, the user ay now activate the exercise ode on the WalkAide unit by pressing and holding for 3 seconds until the indicator light flashes off briefly. This will start the interittent stiulation using the stored exercise paraeters. The intensity can now be increased to an effective, but cofortable level. Exercise will end once the tie set under Duration is reached. In order for the WalkAide unit to be functional again, it ust be turned OFF, then back ON. Turning off the unit will terinate the exercise ode sooner. 40 41
5.6 Usage Log 1. Click on Usage Log listed on the left side of the screen (Figure 34). Click on the Get WalkAide Log icon to retrieve the inforation and then click OK once the inforation has been retrieved. Figure 35: Usage Log Graph screen 4. In the Tabular View, the days, hours and stiulation count are listed in a table (Figure 36). Figure 34: Get WalkAide Usage Log 2. Under Usage Logs on the left of the screen, click on the appropriate date/tie of the ost recent file downloaded. 3. In the Graphical View, two sections of bar graphs will appear (Figure 35). The top blue bar graph shows the total hours of stiulation each day while the botto red bar graph shows the total nuber of stiuli per day. The stiuli fro the exercise ode are NOT included. If desired, the vertical slider on the left of the graph ay be used by dragging it up and down to change the scale of the graph. This would be used in the event that the graph was either too sall to be readable or contained bar graphs that reached the top of the displayed inforation. Figure 36: Usage Log Tabular View screen 42 43
5. A report of the walking trial or Usage Log ay be printed (Figures 37-39). Click on the Print icon in the upper right corner of the screen. Select any one of the walking trials to print a report showing the data analysis screen and associated paraeters. Select any one of the Usage Logs to print a report showing the graphical and tabular view screens. Figure 38: Usage Log Report Figure 39: Usage Log Tabular Data Figure 37: Collected Data Graph and Paraeter Listing 6. Click on Usage Logs again and then click on the Clear WalkAide Log button to reset the WalkAide unit log file so it can keep the log for the next onth. The log will only collect data for up to 72 days. 44 45