ISRCTN17609599已完成未知
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)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 64
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •6. Able to obtain standing from sitting without the assistance of another person.
- •7. Medically stable defined as no significant changes in the participants condition over the last 3 months
- •8. Able to understand and comply with the treatment and assessment procedures
- •9. Able to give informed consent
- •10. Able to start using FES within 2 weeks
排除标准
- •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
研究者
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