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The Effectiveness of Peroneal Nerve Functional Electrical STimulation (FES) for the Reduction of Bradykinesia in Parkinson s Disease: A Pragmatic Two Site Feasibility Study for a Single Blinded Randomised Control Trial (STEPS). Salisbury District Hospital

Parkinson s Disease Bradykinesia: Slowness of movement Hypokinesia: Reduced movement size Akinesia: Difficulty in initiation of movement leading to freezing in gait or upper limb activities Reduce distal muscle power is a common feature, particularly the tibialis anterior (Cioni et al. 1997)

Stimulation intensity Extension MS diagnosed 8 years Using ODFS Pace 1 year Electrodes head of fibula and popliteal fossa Rising ramp Falling Ramp Heel Rise Time Heel Strike

% change to NS week 0 % change relative to NS week 0 % change in median walking speed for CVA compared with NS week 0 25.0 stimulation (S) 20.0 15.0 Total orthotic effect 10.0 5.0 Orthotic gain Training effect no stimulation (NS) CVA S CVA NS MS S MS NS 0.0 0 10 20 30 40 50 60 70 80-5.0-10.0 Initial walking speed: CVA = 0.57 m/s Weeks weeks CVA (n = 116)

Geraldine Mann, Stacey Finn, Paul Taylor A Pilot Study to investigate the Feasibility of Electrical Stimulation to Assist Gait in Parkinson s Disease. Neuromodulation Volume 11 Number 2, 143-149, 2008 Hypothesis FES to the common peroneal nerve to improve heel strike in people with Parkinson s Disease may act to provide a user controlled cutaneous and proprioceptive external cue through provision of active movement to maintain a normal gait pattern and reduce episodes of start hesitation and freezing during gait. 1 month baseline, 2 months FES use, 1 month follow up N=10

Parkinson Syndrome walking without and with FES Increased step length Reduced number of falls Training effect Geraldine E. Mann, Stacey M. Finn, Paul N. Taylor A Pilot Study to investigate the Feasibility of Electrical Stimulation to Assist Gait in Parkinson s Disease. Neuromodulation Volume 11 Number 2 2008

time in seconds Time taken to complete 20m. walk with turn with and without stimulation 40 30 no stim. 20 with stim. Intervention period 10 0 4 8 12 16 week No immediate (orthotic) effect but effect over treatment period - maintained

average stride length in metres Average Stride Length during 3 minute walk with and without stimulation 0.55 0.45 no stim with stim 0.35 Intervention period 0.25 0 4 8 12 16 week Immediate effect sig. improvement over treatment period partially maintained

number of falls Total number of falls each week 30 25 20 15 Treatment Period 10 5 0 0-2 2-4 4-8 8-12 12-14 14-16 weeks Intervention period

Popa L and Taylor P. Functional electrical stimulation may reduce bradykinesia in Parkinson s disease: A feasibility study. Journal of Rehabilitation and Assistive Technologies Engineering January - December 2015 2 week case series with 11 participants Session 1 Assessments only Session 2 Set up of FES Session 3 Next day follow up Session 4 2 weeks later final assessments

10 m walking speed There was a statistically significant improvement in walking speed 2 weeks FES use Mean change = 0.29ms -1 p = 0.002 All participants walked faster after 2 weeks 8 out of 9 achieved a substantial change in walking speed (>0.1ms -1 Perera et al.) Slowest 5 improved functional walking category (Perry et al.)

Questions to be asked Can we recruit and retain enough participants? What are the barriers to recruitment or staying in the study? What do the participants think of the study design? Are we measuring the right things? what is important pwpd? How big does the final study have to be to give meaningful results? We need to test the envisaged final study by trying out a small version of the study UNIVERSITY OF Southampton

Study details 68 participants at 2 centres Group 1 standard care Group 2 standard care with FES 18 week intervention period 4 week follow up Same outcome measures as subsequent RCT UPDRS, 10mWS, MiniBESTest, PDQ39, FES-I, Falls diary, EQ-5D-5L, health resource use. Completed May 2018

Objective 1: Determine recruitment, willingness to be randomised and loss-to-follow rates. 64 out of 68 recruited in 18 months Recruitment rate was 1.8 participant per month per centre 2 did not want to randomised. 1 early withdrawal may be due to disappointment at allocation All participants who entered the study were followed through 80% (51 out of 64) completed the study

163 reply to info sheet 141 screening assessment 5 declined to take part, 2 did not want to be randomised, 15 did not meet criteria 64 did not meet criteria, 12 withdrew, 1 did not want FES 64 eligible and randomised 32 control 32 intervention Week 6 27 control Week 18 27 control Week 22 25 control Week 6 32 intervention Week 18 26 intervention Week 22 26 intervention Control: 3 withdrew, 2 non-related health issues Intervention: 2 withdrew, 2 non-related health issues, 1 did not like sensation, 1 found FES too fiddley. Control: 2 non-related health issues

Objective 2: Participant views on obstacles to recruitment and retention in study. Generally positive comments. Some obstacles identified: Time commitment if working Some felt the control group should receive intervention at end Transport issues Some found the assessment sessions long Push test unpopular

Objective 3: Participant views on what would constitute a meaningful primary outcome measure. 14 Frequency of self-reported factors of walking that were moderately or considerably changed and the factors identified as the most important to the participants. N=25 12 10 8 6 4 2 0 Better Worse most important factor

m/s 0.35 Mean change in walking speed with 95% confidence limits 0.3 0.25 0.2 0.15 0.1 0.05 Substantial clinically meaningful difference FES n=23 Control n=24 0-0.05 Week 0 Week 6 Week 18 Week 22-0.1 Clinical meaningful and statistically significant changes in 10m walking speed

Self reported change in walking speed The high correlation between perceived change in walking speed and perceived change in walking ability supports the use of walking speed as a primary outcome measure Walking speed correlation with walking ability 4 3 R² = 0.8488 2 1 0-3 -2-1 0 1 2 3 4-1 Walking speed Linear (Walking speed) -2-3 -4 Self reported change in overall walking ability

Self reported change in walking speed Also a high correlation between perceived change in walking speed and perceived change in confidence, the most frequently reported most important factor. Perceived change in walking speed against the perceived change in confidence that the walks undertaken can be completed 3.5 3 2.5 2 1.5 1 0.5 R² = 0.7548 0-1.5-1 -0.5 0 0.5 1 1.5 2 2.5 3 3.5-0.5-1 -1.5 Self reported change in confidence

Objective 4: To obtain an estimate of the variability of outcome measures to inform sample-size calculation. Objective 5: To obtain an estimate of the withinsubject correlations to inform sample-size calculation. Estimated sample size at 90% power: n = 278 to 470 Based on walking speed (Range based on the confidence limits of the standard deviation and correlation coefficients)

Axis Title Axis Title Objective 6: To develop and refine resource use data collection methods to inform a future costeffectiveness analysis. Economic evaluation methods were tested Improved EQ-5D-5L score for FES users 7 EQ-5D-5L VAS change 0.15 EQ-5D-5L Index change 6 5 4 MCID 5.23 0.13 0.11 0.09 MCID 0.1 3 2 1 group 1 group 2 0.07 0.05 group 1 group 2 0-1 baseline 6 week 18 week 22 week 0.03 0.01-2 -0.01 baseline 6 week 18 week 22 week -3-0.03

Objective 7: To obtain estimates of likely time frame and costs for a full RCT. To obtain a sample size of 278 to 470, Between 5 and 9 centres Recruiting at a rate of 1.8 per month for 30 months. The study would be complete in 36 months.

Recommendations for the application of FES in PD Treat gait deficit symptomatically Use FES on the more disabled side? Keep the current intensity as low as practical Use gentle rising ramps (150ms) unless otherwise indicated. Use start at 50% Use carer support

% change relative to NS week 0 % change relative to NS week 0 Double the training effect seen with stroke 25.0 20.0 15.0 stimulation (S) Training effect from STEPS 19.2% PD 10.0 5.0 Training effect CVA no stimulation (NS) CVA S CVA NS MS S MS NS 0.0 0 10 20 30 40 50 60 70 80-5.0-10.0 Initial walking speed: CVA = 0.57 m/s Weeks weeks CVA (n = 116)

Thank you The STEPS Team Paul Taylor Salisbury Ben Beare NHNN Trish Sampson Salisbury Val Stevenson NHNN Paul Strike Salisbury Coralie Seary NHNN Dian Padiatchy Salisbury Maggie Donovan-Hall Southampton University James Lee Salisbury Elsa Marques Bristol University Sheila Nell PD Society Peter Thomas Bournemouth University The National Clinical FES Centre www.odstockmedical.com DISCLAIMER: This presentation presents independent research funded by the NIHR under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1014-35012). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. T S E PS