Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease. A Randomized, Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in UPDRS (Unified Parkinson's Disease Rating Scale) III score in the " OFF " medication state, between baseline (D1) and Day 60
研究概览
简要总结
Parkinson's disease is a major source of handicap, for which physical treatments are often underutilized with respect to chemical or surgical treatments. Yet, dopaminergic treatments alone prove unable to stop or control the gradual worsening of motor disability after a few years.
The training program that this study sets out to evaluate aims to restore balance between agonist extensors and antagonist flexors in Parkinson's disease.
There is indeed in Parkinson's disease an imbalance between weak flexors and weaker extensors, with excessive predominance of the flexors. The hypothesis of the study is that a motor strengthening program targeting extensor muscles specifically will improve body posture and restore motor function better than a conventional physical therapy program, in mild to moderate Parkinson's disease.
This is a parallel-group, single blind, randomized trial (investigators will be kept unaware of the physical treatment followed by study subjects).
The duration of patient participation is 5 months: 2-month intervention and 3-month follow-up following the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with Parkinson's disease on UKPDSBB criteria.
- •Hoehn & Yahr stage 2, 3 in "OFF" state
- •Age ≥18 years
- •Patient who agreed to sign an informed consent to participate in this study.
排除标准
- •Patients who cannot or do not wish to follow a motor rehabilitation program for two months with a subsequent follow-up 3 months
- •Intercurrent severe condition jeopardizing the vital or functional prognosis or the ability to participate in rehabilitation sessions.
- •Cognitive dysfunction making effective communication or participation in a rehabilitation program impossible
- •Person not benefiting from French State Health Insurance
- •Current participation in another research protocol
研究组 & 干预措施
Asymmetric Motor Strengthening
干预措施: Asymmetric Motor Strengthening (Other)
Conventional Therapy
干预措施: Conventional therapy (Other)
结局指标
主要结局
Change in UPDRS (Unified Parkinson's Disease Rating Scale) III score in the " OFF " medication state, between baseline (D1) and Day 60
时间窗: Baseline (D1) and Day 60
次要结局
- UPDRS III score in " OFF " medication state(Day 150)
- Global Mobility Task (GMT)(Day 1, Day 60 and Day 150)
- UPDRS III score in " ON " medication state(Baseline (Day 1), Day 60 and Day 150)
- Speed and step length over 20 meters (with 2 turn around, 2 Stand up-Sit down and 2 Sit down-Stand up) at maximal speed in " OFF " medication state(Day 1, Day 60 and Day 150)
- Kinematic measurements of trunk inclination(Day 1 and Day 60)
- Quality of life measured by PDQ-39(Day 1, Day 60 and Day 150)
- Motor power of neck, elbow and knee extensors, measured using a portable dynamometer at Day 1, Day 60 and Day 150(Day 1, Day 60 and Day 150)
- Balance measurement on posturography(Day 1 and Day 60)
- Quantitative testing of large vs small rapid alternating movement in the upper limbs (Hand Tapper)(Day 1, Day 60 and Day 150)
- Mount Sinai Parkinson Impairment Rating Scale(Day 1, Day 60 and Day 150)
- Geriatric Depression Scale - 15 items(Day 1, Day 60 and Day 150)