Parkinson's disease Nervous System Diseases
Conditions
Interventions
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 per
Sponsors
Salisbury NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 21/01/2026: 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 50m with appropriate walking aids, but without assistance from another person 6. Able to obtain standing from sitting without the assistance of another person 7. Able to understand and comply with the treatment and assessment procedures 8. Able to give informed consent Previous participant inclusion criteria as of 13/10/2023: 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. Able to understand and comply with the treatment and assessment procedures 8. Able to give informed consent Previous participant 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
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 21/01/2026: 1. Receiving, or scheduled to start, deep brain stimulation, within the next 6 months 2. Receiving or scheduled to start apomorphine, duodopa or produodopa within the next 6 months (those who are currently taking duodopa and apomorphine are eligible) 3. Pyramidal and/or extrapyramidal systems injuries 4. Untreated or refractory epilepsy with seizures in the last 3 months 5. Pregnancy or planned pregnancy 6. Cardiac pacemaker, or other active medical implanted devices 7. Denervation of the common peroneal nerve, or other neurological condition known to cause dropped foot 8. Severe osteoarticular pathology that involves the calf bones, knee and tibiotarsal joints, or other conditions that significantly affect walking 9. Malignancy or dermatological conditions in the leg that would be stimulated 10. Major cognitive impairment; dementia under treatment for an unresolved deep vein thrombosis in the leg that would be stimulated 11. Participating in another interventional clinical trial (observational studies are permitted) Previous participant exclusion criteria as of 13/10/2023: 1. Receiving, or scheduled to start, deep brain stimulation, within the next 6 months 2. Receiving or scheduled to start apomorphine or duodopa within the next 6 months (those who are currently taking duodopa and apomorphine are eligible) 3. Pyramidal and/or extrapyramidal systems injuries 4. Untreated or refractory epilepsy with seizures in the last 3 months 5. Pregnancy or planned pregnancy 6. Cardiac pacemaker, or other active medical implanted devices 7. Denervation of the common peroneal nerve, or other neurological condition known to cause dropped foot 8. Severe osteoarticular pathology that involves the calf bones, knee and tibiotarsal joints, or other conditions that significantly affect walking 9. Malignancy or dermatological conditions in the leg that would be stimulated 10. Major cognitive impairment; dementia under treatment for an unresolved deep vein thrombosis in the leg that would be stimulated 11. Participating in another interventional clinical trial (observational studies are permitted) Previous participant exclusion criteria: 1. Able to walk 10m in less than 8.0s (walking speed greater than 1.25ms-1) 2. On, or scheduled to start, PD treatment other than standard drug therapy (deep brain stimulation, duodopa, apomorphine) 3. Atypical or secondary parkinsonism, or parkinsonism related to other neurodegenerative diseases 4. Pyramidal and/or extrapyramidal systems injuries 5. Untreated or refractory epilepsy with seizures in the last 3 months 6. Pregnancy or planned pregnancy 7. Cardiac pacemaker, or other active medical implanted devices 8. Denervation of the common peroneal nerve, or other neurological condition known to cause dropped foot 9. Severe osteoarticular pathology that involves the calf bones, knee and tibiotarsal joints, or other conditions that significantly affect walking 10. Malignancy or dermatological conditions in the leg that would be stimulated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Previous 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactAbbey Tufft
Outcome results
None listed