ISRCTN13120555进行中（未招募）Unknown
The efficacy of peroneal nerve functional electrical stimulation for the reduction of bradykinesia in Parkinson’s disease: An assessor-blinded randomised controlled trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 234
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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