Interest of Hydrophysiotherapy Care in Parkinson Disease's Non-motor Symptoms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 126
- 主要终点
- Change of score on Parkinson's Disease Questionnaire 39 (PDQ 39) after reeducation
研究概览
简要总结
Parkinson Disease (PD) is a neurodegenerative disorder who begin around 55 years old, characterized by brain's backmatter's dopamine neuron destruction, involved in motor control. Diagnosis is made with presence of 3 of 4 disease's cardinal sign: bradykinesia, rigidity, resting tremor, walking troubles. Treatments enhance patient's quality of life, but do not allow to stop disease's evolution, who is specific depending on a lot of factors. For some years, PD's non motor symptoms (NMS) - in particular pain, anxiety, depression, sleep disorders - have been highlighted and turn out to impair sometimes quality of life even though motor symptoms are controlled. This project's main aim is to evaluate if aquatic environment's care lead to an advantage on PD's NMS, symptoms currently underestimated, insufficiently in care and having a harmful influence on quality of life. Collaboration of the University Hospital (Neurology Dpt), the Physical Medicine and Rehabilitation Regional Institute, Grand Nancy Thermal, and France Parkinson Association, will allow in this way to offer on PD's NMS, postural control impairments, and walking troubles an alternative or further non-pharmacological therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having get a complete information on study's organization and having given written informed consent,
- •affiliated to a social security system,
- •suffering from Parkinson's disease (stage 2 or 3 of Hoehn and Yahr),
- •with motor fluctuation lower than 25% of awaked time,
- •with dyskinesia lower than 25% of awaked time (according to MDS-UPDRS scale),
- •with stable pharmacological treatment during the 30 days before study,
- •already benefiting of a physiotherapy.
排除标准
- •, patients:
- •receiving treatment by apomorphine or Duodopa pump,
- •benefiting of brain stimulation,
- •taking occasionally benzodiazepine,
- •with dementia (MDS-UPDRS 1.1 score > 3),
- •having had a sprain on a lower limb joint 3 months or less before the beginning of study,
- •having head trauma consequences,
- •having vertebrae pain,
- •with freezing,
- •having skin trouble leading to a contraindication of aquatic activities,
- •concerned by L. 1121-5, L. 1121-7 and L 1121-8 articles of French public health code.
研究组 & 干预措施
Aquatic rehabilitation
干预措施: Aquatic rehabilitation (Other)
Land based physical activities
干预措施: Land based physical activities (Other)
Conventional rehabilitation
干预措施: Conventional rehabilitation (Other)
结局指标
主要结局
Change of score on Parkinson's Disease Questionnaire 39 (PDQ 39) after reeducation
时间窗: Day 1, day 28 (+7)
Total score to PDQ 39 (between 0 and 156, a lower score being a better outcome), which evaluates quality of life, before and after reeducation
次要结局
- Non-Motors Signs (NMS) Questionnaire score(Day 1, day 28 (+7), day 56 (+/-7))
- Mean Equilibrium ellipse area(Day 1, day 28 (+7), day 56 (+/-7))
- Ratio of sensory inputs.(Day 1, day 28 (+7), day 56 (+/-7))
- Step width(Day 1, day 28 (+7), day 56 (+/-7))
- Persistence of change of score on PDQ 39 after reeducation(Day 28(+7), day 56 (+/-7))
- Distance of walking(Day 1, day 28 (+7), day 56 (+/-7))
- PDQ 39 sub-scores(Day 1, day 28 (+7), day 56 (+/-7))
- Mean Equilibrium path length(Day 1, day 28 (+7), day 56 (+/-7))
- Step high(Day 1, day 28 (+7), day 56 (+/-7))
- Subjective effort(Day 1, day 28 (+7), day 56 (+/-7))
- Parkinson's Disease specific Pain score(Day 1, day 28 (+7), day 56 (+/-7))
- Global Pain score(Day 1, day 28 (+7), day 56 (+/-7))
- Entropy(Day 1, day 28 (+7), day 56 (+/-7))
- Step length(Day 1, day 28 (+7), day 56 (+/-7))
- Parkinson Anxiety Scale (PAS) score(Day 1, day 28 (+7), day 56 (+/-7))
- Time for Time Up and Go (TUG)(Day 1, day 28 (+7), day 56 (+/-7))
- Walking velocity(Day 1, day 28 (+7), day 56 (+/-7))