The effectiveness of peroneal nerve functional electrical simulation for the reduction of bradykinesia in Parkinson's disease: A feasibility study for a randomised control trial.
Study Goal
To assess the feasibility of a multi-site randomised controlled trial evaluating the effect of functional electrical stimulation on bradykinesia in people with Parkinson's disease.
Results Summary
The study found a mean difference of 0.14 m/s in walking speed between groups, suggesting feasibility and potential efficacy of the intervention. Both the study protocol and intervention were deemed acceptable, though modifications were recommended.
Population
64 participants with idiopathic Parkinson's disease and slow gait (<1.25 m/s).
Effective Dosage
Not specified (functional electrical stimulation delivered to the common peroneal nerve while walking).
Duration
18 weeks intervention period with 4 weeks post-intervention follow-up.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Functional electrical stimulation delivered to the common peroneal nerve while walking in addition to standard care | increase | 10 m walking speed | people with Parkinson's disease and slow gait <1.25 ms | 0.14 ms | improved | #1 |
Functional electrical stimulation delivered to the common peroneal nerve while walking in addition to standard care | decrease | Unified Parkinson's Disease Rating Scale (UPDRS) | people with Parkinson's disease and slow gait <1.25 ms | -4.7 points | improved | #2 |
OBJECTIVES: To assess the feasibility of a multi-site randomised controlled trial to evaluate the effect of functional electrical stimulation on bradykinesia in people with Parkinson's disease. DESIGN: A two-arm assessor blinded randomised controlled trial with an 18 weeks intervention period and 4 weeks post-intervention follow-up. SETTING: Two UK hospitals; a therapy outpatient department in a district general hospital and a specialist neuroscience centre. PARTICIPANTS: A total of 64 participants with idiopathic Parkinson's disease and slow gait <1.25 ms INTERVENTIONS: Functional electrical stimulation delivered to the common peroneal nerve while walking in addition to standard care compared with standard care alone. MAIN MEASURES: Feasibility aims included the determination of sample size, recruitment and retention rates, acceptability of the protocol and confirmation of the primary outcome measure. The outcome measures were 10 m walking speed, Unified Parkinson's Disease Rating Scale (UPDRS), Mini Balance Evaluation Systems Test, Parkinson's Disease Questionnaire-39, EuroQol 5-dimension 5-level, New Freezing of Gait questionnaire, Falls Efficacy Score International and falls diary. Participants opinion on the study design and relevance of outcome measures were evaluated using an embedded qualitative study. RESULTS: There was a mean difference between groups of 0.14 ms CONCLUSION: The study design and intervention were feasible and supportive for a definitive trial. While both the study protocol and intervention were acceptable, recommendations for modifications are made.