ANNEXURE II. Consent Form

Transcription

1 ANNEXURE II Consent Form I, voluntarily agree to participate in the research work entitled Gait Pattern in Post Stroke Hemiparetic Patients: Analysis and Correction. All my questions have been satisfactorily answered and the risks involved (if any) have been explained to me. However, the option of discontinuing from the study/research work at any point of time is reserved with me.

2 ANNEXURE III Data Collection Form Name: Code: Age: Date: Address: Sex: Occupation: Diagnosis: Side Involved: Time Since onset:

3 Length of training: Use of Gait aid (Y/N): Level of spasticity: Hip Adductors: Knee Extensors: Ankle Plantar flexors: Voluntary control: Gait Velocity: Cadence: Stride length (Left): Stride length (Right): Step length (Left): Step length (Right):

4 WISCONSIN GAIT SCALE (WGS) Submeasure Finding Points Use of hand gait aid No gait aid Minimal gait aid use Minimal gait aid use wide base Marked use Marked use wide base 4 5 Stance time on impaired side Equal (time spent on affected side same as time spent on unaffected side during single leg stance) Unequal Very brief Step length of unaffected side Step through (heel of unaffected foot clearly advances beyond the toe of the affected foot) Foot does not clear Step to (unaffected foot placed behind of up to affected foot but not beyond) Weight shift to the affected side (with or Full shift head and trunk shift laterally over the

5 without aid) affected foot gait during the single stance Decreased shift Very limited shift Stance width Normal (up to shoe width between feet) Moderate (up to shoe widths) Wide (more than shoe widths) Guardedness None (good forward movement with no hesitance noted) Slight Marked hesitation Hip extension of Equal extension (hips equally extend during affected side push off; maintains erect posture during toe off) Slight flexion Marked extension External rotation Same as unimpaired leg during initial swing Increased rotation Marked Circumduction at None (affected foot adducts no more than

6 mid swing unaffected foot during swing) Moderate Marked Hip hiking at mid None (Pelvis slight dips during swing) swing Elevation Vaults

7 Knee flexion from Normal (affected knee flexes equally to toe off to mid swing unaffected side) Some Minimal None 4 Toe clearance Normal (Toe clears floor throughout swing) Slight drag Marked Pelvic Rotation at Forward (pelvis rotated forward to prepare for terminal swing heel strike) Neutral Retracted Initial foot contact Heel strike (heel makes the initial contact with the floor) Foot flat No contact of heel WGS score: Treatment Category:

8 ANNEXURE IV Sample Size Calculation I. Phase I: The sample size for Phase was determined as per the guidelines given by Mahajan, 0. According to him, normally the cut off is taken at 0. A sample of size greater than 0 is considered large enough for statistical purposes. When the size is 0 or more, there means will lie closer to each other and will also be in the neighborhood or population mean. In other words, a small sample lacks precision. Hence the size in Phase for post stroke hemiparetic patients and healthy asymptomatic subjects was of 0 each.

9 II. Phase II: For Phase of the study, the sample size was determined by the following formula (Mahajan, 00): n = 4σ E Where n = sample size σ = standard deviation E = Allowable error in the sample mean As the standard deviation was not known, the standard deviation was estimated by conducting a pilot study on 0 post stroke hemiparetic patients. The standard deviation of pre correction WGS scores was calculated and in this case the standard deviation came out to be The allowable error was at 5% risk. Therefore, n = 4 x (4.06) x n = 4 x n = 6.48 Hence, the sample size in each interventional group was 0

10 ANNEXURE V Wisconsin Gait Scale (WGS) Submeasure Finding Points Use of hand gait aid No gait aid Minimal gait aid use Minimal gait aid use wide base Marked use Marked use wide base 4 5 Stance time on impaired side Equal (time spent on affected side same as time spent on unaffected side during single leg stance) Unequal Very brief Step length of Step through (heel of unaffected foot clearly unaffected side advances beyond the toe of the affected foot) Foot does not clear Step to (unaffected foot placed behind of up to affected foot but not beyond) Weight shift to the Full shift head and trunk shift laterally over the affected side (with or affected foot gait during the single stance without aid) Decreased shift Very limited shift Stance width Normal (up to shoe width between feet)

11 Moderate (up to shoe widths) Wide (more than shoe widths) Guardedness None (good forward movement with no hesitance noted) Slight Marked hesitation Hip extension of Equal extension (hips equally extend during affected side push off; maintains erect posture during toe off) Slight flexion Marked extension External rotation Same as unimpaired leg during initial swing Increased rotation Marked Circumduction at None (affected foot adducts no more than mid swing unaffected foot during swing) Moderate Marked Hip hiking at mid None (Pelvis slight dips during swing) swing Elevation Vaults

12 Knee flexion from Normal (affected knee flexes equally to toe off to mid swing unaffected side) Some Minimal None 4 Toe clearance Normal (Toe clears floor throughout swing) Slight drag Marked Pelvic Rotation at Forward (pelvis rotated forward to prepare for terminal swing heel strike) Neutral Retracted Initial foot contact Heel strike (heel makes the initial contact with the floor) Foot flat No contact of heel Total score = Sum (points for to 0, to 4) + [/5 (points for )] + [/4 (points for )] Interpretation: Minimum score:.5 Maximum score: 4

13 ANNEXURE VI Scoring of MAS 0 No increase in tone Slight increase in muscle tone, manifested by a catch and release or minimal resistance at the end of the ROM when the affected part(s) is moved in flexion or extension + Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved Considerable increase in muscle tone, passive movement difficult 4 Affected part(s) rigid in flexion or extension Reference: Bohannon and Smith, 987

14 ANNEXURE VII Brunnstrom stages of motor recovery The 6 stages are as follows (Brunnstrom, 970; O'Sullivan, 007; Wade, et al., 985): Stage Description Immediately following a stroke there is a period of flaccidity whereby no movement of the limbs on the affected side occurs. Recovery begins with developing spasticity, increased reflexes and synergic movement patterns termed obligatory synergies. These obligatory synergies may manifest with the inclusion of all or only part of the synergic movement pattern and they occur as a result of reactions to stimuli or minimal movement responses. Spasticity becomes more pronounced and obligatory synergies become strong. The patient gains voluntary control through the synergy pattern, but may have a limited range within it. 4 Spasticity and the influence of synergy begins to decline and the patient is able to move with less restrictions. The ease of these movements progresses from difficult to easy within this stage. 5 Spasticity continues to decline, and there is a greater ability for the patient to move freely from the synergy pattern. Here the patient is also able to demonstrate isolated joint movements, and more complex movement combinations. 6 Spasticity is no longer apparent, allowing near-normal to normal movement and coordination.

15 ANNEXURE VIII Test Position for Patient and Investigator and Test Movement for assessment of spasticity (Blackburn et al., 00 and Ghotbi et al., 0): Muscle Patient Investigator Ankle plantar flexors (Soleus) Side lying, with the hips in 45 of flexion and the knees in 45 of flexion. Head and trunk are in a straight line. In front of the patient, examiner places one hand proximal to the ankle joint to stabilize the lower leg and one hand under the foot, with the thumb on the lateral aspect of the calcaneus, the fingers on the medial aspect of the calcaneus, and the palm on the plantar surface of the foot. The patient is asked to relax as much as possible. The ankle is moved from maximum plantar flexion to maximum dorsiflexion. Knee extensors (Quadriceps femoris) Hip Adductors Side lying, with the hips and knees in maximum extension. Head and trunk are in a straight line. A pillow can be used behind the hips, if necessary, to stabilize the patient. Supine, head in midline, and lower limbs in extended position Behind the patient, examiner places one hand just proximal to the knee, on the lateral surface of the thigh, to stabilize the femur and one hand just proximal to the ankle. The knee is moved from maximum extension to maximum flexion. On side being tested, rater placed one hand underneath limb close to knee and other hand supported limb close to ankle. Limb is moved into full abduction (without rotation).

16 ANNEXURE IX NDT based gait training program The following treatment techniques and activities were given as described by Lennon (00). The techniques/activities were grouped into 4 categories according to the treatment goal, preparation, facilitated movements, gait-specific activities, and functional activities: A. Preparation: Normalization of tone using proximal mobilization of the trunk, shoulder girdle, or pelvis. Realignment of joints and muscles using specific rotatory mobilization of muscle. This refers to the use of a linear stretch in the direction of the muscle fibers while maintaining stability through improved alignment of the appropriate joints.. Circular trunk mobilizations. Shoulder girdle mobilizations. Inhibitory mobilizations of any specific muscle B. Facilitated movements: Performance of normal movement patterns of the trunk, pelvis, and limbs with the investigator guiding the movements while providing proximal stability to allow for selective movement in the limbs. Facilitated movements were sub grouped according to body segments: proximal (trunk, pelvis, hip), distal (knee, ankle, foot), and upper limb. Proximal 4. Weight transfer to unaffected side (sitting)

17 5. Weight transfer to affected side (sitting) 6. Anterior/posterior pelvic tilt (sitting) 7. Lateral pelvic tilt (sitting) 8. Moving the trunk over the affected arm with weight bearing on the arm (sitting) 9. Reaching to the unaffected side (sitting/standing) 0. Weight transfer in stride standing (standing). Prone standing (in standing, the patient s upper body is supported on a treatment bed placed at waist height in front). Weight transfer in step position (standing). Anterior/posterior pelvic tilt (standing) 4. Reaching to the unaffected side (standing) 5. Reaching across the body with the unaffected limb to the affected side (standing) 6. Knee flexion/extension with unaffected foot on a step (standing) 7. Bridging (supine) 8. Holding different positions with the affected lower limb (supine) 9. Selective movement of the hip (supine/side lying) (basic movement patterns of the hip; this refers to the ability to move the hip independently from the knee or foot) Distal (leg) 0. Selective movement of the knee (supine)

18 . Selective movement of the foot (supine). Placing the lower limb (supine) (the response of the lower limb to being moved by the therapist) C. Gait-specific activities. Working on the different phases of gait or walking with the assistance of the therapist. Stance phase re-education 7. Stepping with the unaffected lower limb forward 8. Stepping with the unaffected lower limb backward 9. Stepping with the unaffected lower limb sideways 0. Stepping with the unaffected lower limb on and off a step Swing phase re-education. Stepping with the affected lower limb Walking. Walking around a plinth (side stepping or using the treatment bed for support on the unaffected side). Walking D. Functional activities 4. Standing up from sitting 5. Stair climbing

19 Each patient was given a physiotherapy program of a total of 8 weeks duration, with 5 physiotherapy sessions per week, each therapy session lasting for about 60 minutes.

20 ANNEXURE X Lower limb strengthening program The lower limb strengthening protocol required each patient to isotonically exercise the affected LE using external resistance (Sullivan et al., 007). The strengthening was done for six specific muscle groups (hip flexors, hip extensors, knee flexors, knee extensors, ankle dorsiflexors, and ankle plantar flexors). For example, the starting position against gravity for the ankle dorsiflexors was the position for testing ankle movements independent of synergy (ie, standing, knee extended, with foot dorsiflexed against gravity). If the patient could isolate ankle dorsiflexion in this position, the dorsiflexor would be loaded with manual resistance given by the investigator. If the participant could not isolate the dorsiflexors in the standing position, then dorsiflexion against gravity in a sitting position was used (ie, the less difficult position to activate the dorsiflexors). If the participant could not activate the dorsiflexors in a sitting position, then the participant was positioned supine and used hip and knee flexion to activate the dorsiflexors. Progression included moving to a more isolated movement position or increasing resistance within a position where activation occurred. During the strengthening session, each muscle group was exercised for sets of 0 repetitions. The progression of exercise was done by either increasing the load within an exercise type or progressing the patient to the more difficult exercise-type level.

21 ANNEXURE XI Static cycling program A stationary cycle was used for imparting the static cycle program. The subject's feet were strapped firmly to the pedals, if required, with the metatarsalphalangeal joints positioned directly over the center of the pedals with leather straps. The bicycle seat height was adjusted for each subject and so that the knee angle was approximately 70 0 when the foot was at the lowest point in the pedal cycle. The patients were seated on a static cycle and were asked to complete 0 sets of 5 to 0 revolutions in each session. The subjects were instructed to grip the handlebars with both hands. If upperextremity hemiparesis prevented a volitional grip, the hand was held on the handlebar by an assistant. They were given at least minutes to rest between sets (Sullivan, 007)

22 ANNEXURE XII Conventional physiotherapy program The conventional physiotherapy gait correction program comprised of the exercises in anatomical planes, passive movements, active movements, passive stretching exercises, practice of ADL etc. (Dickstein et al., 986). Exercises in anatomical planes Progress was encouraged either by gradual increase in the number of joints involved or by increasing resistance to a requested movement. Passive movements were administered to immobile joints: Hip : Flexion, extension, adduction, abduction, medial and lateral rotation Knee flexion and extension Ankle : Dorsiflexion, plantar flexion, inversion and eversion Passive Stretching Hamstrings Plantar flexors Adductors Practice of ADL began as early as possible. Rapid acquisition of independence was given higher priority than the quality of movements by which it was achieved. Gait training usually was started by supporting the patient at his sound side.

23 ANNEXURE XIII Statistical tools The Statistical Analysis was done using SPSS (version 6). The various statistical tests applied for data analysis have been mentioned below:. Arithmetic mean X X N. Standard Deviation (SD) X X N. Stadard Error (SE) SE S. D / N 4. Confidence Interval s x.96 x. 96 n s n 5. Paired t-test t n d d d n 6. Unpaired t-test

24 n n s x x t n n x x x x s i n i j n j

25 7. Carl Pearson's coefficient of correlation r N xy x y N x x N y y Where N = number of pairs of scores xy = sum of the products of paired scores x = sum of x scores y = sum of y scores x = sum of squared x scores y = sum of squared y scores 8. One Way ANOVA Test Within - groups estimate of y ij yij y j SSWG MSWG n df j j WG Between groups estimate of n y y j j j SSBG y MSBG = k df BG F between conditions = F between Subjects = MS between MS error MS subjects MS error

26 Where, MS between = SS between df Subjects MS Subjects = SS subjects df between MS error = SS error df error SS between = / n x Tc / SS subjects = / C x Ts / N N SS total = x x / N SS error = SS total SS between SS subjects 9. Post HOC Test: Bonferroni The Bonferroni simply calculates a new pair wise alpha to keep the family wise alpha value at.05 (or another specified value). The formula for doing this is as follows: B c FWE where B is the new alpha based on the Bonferroni test that should be used to evaluate each comparison or significance test, FWE is the family wise error rate as computed in the first formula, and c is the number of comparisons (statistical tests).

27 Annexure XIV Master Chart I. Healthy asymptomatic individuals S. No Code Age Step length- Dominant Step length - Non dominant Stride length Cadence Velocity Low pressure area Upper part (%) High pressure area Upper part (%) Low pressure area Middle part (%) High pressure area Middle part Low pressure area Lower part High pressure area Lower part N N N N N N N N N N N N N

28 4 N N N N N N N N N N N N N N N N N

29 II. Post Stroke Hemiparetic Patients S. No. Code No. Age (yrs) Step Length (Affected) (cm) Step Length (Unaffecte) (cm) Stride Length (cm) Cadence (steps/min) MAS - Hip MAS - Knee MAS - Ankle Voluntary Control Velocity (cm/s) WGS Score Affected Foot (%) Low pressure area Upper part (%) High pressure area Upper part (%) Low pressure area Middle part (%) High pressure area Middle part Low pressure area Lower part A A A A A A A A A A A A A A A A A A

30 9 A A B B B B B B B B B B B B B B B B B B B B C C C C C C

31 47 C C C C C C C C C C C C C C D D D D D D D D D D D D D D

32 75 D D D D D D