Effect of Adapted Physical Activity, During Rehabilitation Stay, on Abilities and Quality of Life of Huntington Patients and Their Relatives "HUNT'ACTIV-MH-REHAB MOVE MORE TO LIVE BETTER"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Motor function score of Unified Huntington's Disease Rating Scale (UHDRS)
研究概览
简要总结
Intro:
Huntington's disease is a neurodegenerative disease that affects the brain, inducing a dysfunction and death of the middle spiny striatal projection neurons and a progressive alteration of cognitive and motor functions, and psycho-behavioral problems. There is currently no curative treatment but we know hat a multidisciplinary care can optimize the functioning and the quality of life of the patients with Huntington's disease.
A meta-analysis of 18studies indicates that exercise and physical activity can improve motor function, gait speed and balance, and would also improve self-confidence, independence, well-being, reduced apathy and better socialization with family and friends.
Hypothesis/Objective The hypothesis is that the inclusion of a 4 week-program with Adapted Physical Activity (APA) during a rehabilitation stay will improve some motor, cognitive and psycho-behavioral abilities, compared to the control group.
Method
The patients will be randomized into two groups :
The control group will have the "classic" program performed in the standard of care with: kinesitherapy, soft gym, medico-social workshop, cognitive workshop, creative workshop, individual care (rehabilitation, rest, and creation).
The experimental APA group will have in addition of the classic program, 6 APA workshops per week with collective support : Adapted Physical workshops, adapted cycling, therapeutic (horseback/equestrian) riding, cultural or leisure outings, situation tests
For the two groups, at the start of the 4 weeks of rehabilitation program an initial visit will be performed with, as part of this research, a clinical examination, a neurological examination, a dietary consultation, as well as a biological assessment as part of habitual care.
The clinical examination, the neurological examination and the dietary consultation will be performed each week, during the 4 weeks of the program,
At the end of the study, one month after the rehabilitation of the patient, a visit by phone-call will be performed for the patient and his caregiver.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Having a physical or psychiatric condition preventing the completion of the program and assessments.
- •Having a history of additional major neurological disorders such as a stroke or an orthopedic condition limiting mobility
- •Any difficulty to understand or read French which could possibly invalidate the relevance of the application of questionnaires according to the opinion of the investigator
- •Addictions, alcohol dependence
- •Any other neurological, musculoskeletal or cardiovascular disease which could lead to errors in the assessment
- •Participation to another interventional research or being in the exclusion period following a previous research if applicable
- •Patient under AME (except if exemption from affiliation)
- •Exclusion criteria for the Caregiver :
- •Having a physical or psychiatric condition preventing the completion of the program and assessments.
- •Any difficulty to understand or read French which could possibly invalidate the relevance of the application of questionnaires according to the opinion of the investigator
- •Under tutelage or guardianship
结局指标
主要结局
Motor function score of Unified Huntington's Disease Rating Scale (UHDRS)
时间窗: Change from Baseline at 1 month
UHDRS:Unified Huntington's Disease Rating Scale , minimum value: 0 maximum value: 124 higher score means a worse outcome Success will be defined by an improvement of the motor function score
次要结局
- cognitive function score of Unified Huntington's Disease Rating Scale (UHDRS) using Stroop test(Change from Baseline at 1 month)
- psycho-behavioral function score of Unified Huntington's Disease Rating Scale (UHDRS)(Change from Baseline at 1 month)