Assessment of electrical stimulation to improve movement for people who have Parkinson’s disease
- Conditions
- Parkinson's diseaseNervous System Diseases
- Registration Number
- ISRCTN13120555
- Lead Sponsor
- Salisbury NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 234
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:
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
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method