ISRCTN13120555
Active, Not Recruiting
N/A
The efficacy of peroneal nerve functional electrical stimulation for the reduction of bradykinesia in Parkinson’s disease: An assessor-blinded randomised controlled trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson's disease
- Sponsor
- Salisbury NHS Foundation Trust
- Enrollment
- 234
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current 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:
Exclusion Criteria
- •Current 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
Outcomes
Primary Outcomes
Not specified
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