Assessment of electrical stimulation to improve movement for people who have Parkinson’s disease

INTERVENTION: Functional electrical stimulation (FES) The CE‐marked ODFS Pace is a small, battery‐powered, single‐channel FES device used to correct dropped foot. Electrical stimulation is applied to the common peroneal nerve using skin surface self‐adhesive electrodes placed over the head of the fibula and the anterior tibialis muscle. Intervention participants will be asked to walk every day with the device and use the device whenever they feel it assists their walking. The clinical pathway established for multiple sclerosis and stroke patients will be used, with clinical (unblinded) follow‐up at weeks 1, 6 and 18. The intervention is used in addition to usual care. The control group is Usual Care. Participants will be individually randomised 1:1 to FES with usual care or usual care alone, stratified by recruiting centre to ensure approximately equal numbers of participants in the treatment and usual care‐only groups at each centre. PenCTU will centrally administer the randomisation using a bespoke, web‐based randomisation system. The randomisation sequence, using variable block sizes, will be generated by a statistician independent of the trial team and implemented through a secure web‐based system, ensuring allocation concealment. CONDITION: Parkinson's disease ; Nervous System Diseases PRIMARY OUTCOME: Confirmation or otherwise of the hypothesis that FES reduces whole body bradykinesia with a clinically important effect size on walking speed at 18 weeks SECONDARY OUTCOME: 1. Determine if any effects remain for up to four weeks after FES is withdrawn ; 2. Investigate the effect of FES on other aspects of Parkinsonian gait and living life with PD, to inform the need and design of future research. To achieve this, we will produce first estimates of the effect size of FES on secondary outcome measures for: ; 2.1. Hypokinesia ; 2.2. Akinesia ; 2.3. Falls and balance ; 2.4. Activities of daily living ; 2.5. Activity ; 2.6. Quality of Life ; 2.7. Cost/utility ; 2.8. The effect on gait while using FES ; 3. Determine how pwPD and their carers perceive the usefulness and practical experience of FES use and its therapeutic effect ; 4. Determine the safety of FES in pwPD ; 5. Investigate potential mechanisms of action of FES in PD, by determining:; 5.1. short‐term (up to 6 weeks) changes in inter‐limb coordination, APA and limb bradykinesia while stepping and walking; 5.2. The link between putative mechanisms of action and their relationship to walking speed at 6 and 18 weeks, through causal mediation analysis; 5.3. Changes over time in the strength of muscles directly targeted and not targeted by the intervention INCLUSION CRITERIA: 1. Aged 18 years and above (no upper age limit) 2. Idiopathic Parkinson’s disease 3. Hoehn and Yahr stages I to IV under medication 4. Difficulty in walking due to Parkinson’s disease bradykinesia, defined as a measured 10m walking speed (10mWS) of less than 1.25ms‐1 5. Able to walk 10m with appropriate walking aids, but without assistance from another person 6. Able to obtain standing from sitting without the assistance of another person 7. Medically stable, defined as no significant changes in the participant’s condition over the last 3 months 8. Able to understand and comply with the treatment and assessment procedures 9. Able to give informed consent