ISRCTN17609599
Completed
N/A
The effectiveness of peroneal nerve functional electrical stimulation (FES) for the reduction of bradykinesia in Parkinson’s disease: A pragmatic feasibility study for a single blinded randomised control trial (STEPS)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Specialty: Dementias and neurodegeneration, Primary sub-specialty: Parkinson's Disease
- Sponsor
- Salisbury NHS Foundation Trust
- Enrollment
- 64
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Preprint results see attached file 33440 preprint results.pdf (added 12/08/2022) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33826449/ (added 12/08/2022)
Investigators
Eligibility Criteria
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 with gait (clinical observation by experienced clinician):
- •4\.1\. Reduced dorsiflexion or eversion at any point in the swing or weight acceptance phase of gait,
- •4\.2\. Bradykinesia demonstrated by a measured 10m walking speed of less than 1\.25ms\-1
- •4\.3\. Festination demonstrated by walking with short rapid strides
- •4\.4\. Akinesia demonstrated by exhibiting freezing episodes while walking. This may be in restricted areas such as doorways.
- •4\.5\. Hypokinesia demonstrated by walking with a short stride length
- •5\. Able to walk 10m with appropriate walking aids but without assistance from another person
Exclusion Criteria
- •1\. Able to walk 10m in less than 8s (walking speed \>1\.25ms\-1\) indicating non limited functional walking
- •2\. Other treatment than standard drug therapy (FES, deep brain stimulation, duodopa, apomorphine)
- •3\. Atypical or secondary parkinsonism or parkinsonism related to other neurodegenerative diseases
- •4\. Dropped foot due to any neurological condition other than Parkinson’s Disease
- •5\. Untreated or refractory epilepsy
- •6\. Pregnancy
- •7\. Cardiac pacemaker, or other active medical implanted devices
- •8\. Denervation of the common peroneal nerve
- •9\. Malignancy or dermatological conditions in the area of the electrodes
- •10\. Major cognitive impairment or dementia
Outcomes
Primary Outcomes
Not specified
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