CARE-MH: Comparison of Two Cognitive-Motor Rehabilitation Approaches Via Exergames: a Study of Cognitive, Motor and Behavioral Functions in Huntington's Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Berg Balance Scale (BBS)
研究概览
简要总结
Huntington's disease (HD) is a rare, hereditary neurodegenerative disorder. It generally manifests itself between the ages of 40 and 50, and results in motor impairment (choreic movements, balance disorders, gait disorders, etc.), cognitive impairment (executive functions, attention, etc.) and behavioral impairment (apathy, depression, irritability, etc.). To date, there is no curative treatment for HD, and drug therapies have little effect on symptomatology, particularly motor symptoms. Physical activity and cognitive stimulation appear to be promising tools in the fight against the progression of various symptoms in certain progressive neurological conditions, including HD. In addition, the use of exergame as an interface is becoming increasingly widespread and offers encouraging prospects in the management of certain neurodegenerative diseases (Parkinson's disease, multiple sclerosis, spinocerebellar ataxia type 3).
The aim of our project is to carry out a preliminary evaluation of the clinical benefit of a management program combining physical activity and cognitive stimulation, compared with a sequential management program.
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
- •Adults at inclusion
- •Huntington's disease diagnosed and confirmed by genetic analysis
- •Patient with stage 1-2 HD with a motor UHDRS score ≥ 5 and a CFT between 6 < CFT ≤ 13
- •Patient with written informed consent or third-party consent
- •Affiliated or beneficiary of a social security scheme
排除标准
- •Poor understanding of the French language
- •Participation in interventional research modifying management
- •History likely to interfere with cognition (established stroke, sequelae of traumatic brain injury, active epilepsy, learning disorders, alcohol dependence syndrome, drug use, psychiatric disorders), severe cognitive deficit (MMSE <16), clinically significant pathological condition which, in the investigator's opinion, could interfere with the subject's safety or the evaluation of study results
- •Pregnant or breast-feeding women
- •Persons deprived of their liberty by administrative or judicial decision
- •Persons under compulsory psychiatric care
研究组 & 干预措施
Synergistic management
干预措施: Synergistic management (Other)
Sequential management
干预措施: Sequential management (Other)
结局指标
主要结局
Berg Balance Scale (BBS)
时间窗: Sessions are held three times a week for 12 weeks.
The BBS is a scale comprising 14 tests designed to assess static and dynamic balance. Each test is given a score ranging from 0 (inability to perform the test) to 4 (no difficulty in performing the test), giving a final score out of 56 points (the higher the score, the better the balance skills). The tests included in the BBS are: * Sitting * Standing without support * Standing with feet together * Standing with eyes closed * From sitting to standing * Move from standing to sitting * Transfer between two chairs * Standing in tandem * Stand on one leg * Alternating feet on a step or stair while standing * Rotate trunk * Turn around to look over shoulders * Forward movement with arms outstretched * Picking up an object from the ground
次要结局
- The working memory subtest of the Wechsler Intelligence Scale for Adults 4th Edition (WAIS-IV, subtest "Number Memory")(baseline - Day 90- Day 180)
- L'Unified Huntington's Disease Rating Scale - Total Motor Score (UHDRS-TMS)(baseline - Day 90- Day 180)
- Six-Minute Walk Test (6MWT)(baseline - Day 90- Day 180)
- 30 second Chair Stand Test (30CST)(baseline - Day 90- Day 180)
- Mini Mental State Examination (MMSE)(baseline - Day 90- Day 180)
- UHDRS cognitive tests - The Stroop test(baseline - Day 90- Day 180)
- UHDRS cognitive tests - The Symbol Digit Modalities Test (SDMT)(baseline - Day 90- Day 180)
- UHDRS cognitive tests - Verbal fluency task(baseline - Day 90- Day 180)
- UHDRS cognitive tests - The Trail Making Test (TMT)(baseline - Day 90- Day 180)
- L'Hospital Anxiety and Depression Scale (HADS)(baseline - Day 90- Day 180)
- Problem Behaviours Assessment for Huntington's Disease (PBA-HD)(baseline - Day 90- Day 180)
- SF- 12 self-questionnaire.(baseline - Day 90- Day 180)
- Acceptance and feasibility(baseline - Day 90- Day 180)
- Participants' satisfaction(baseline - Day 90- Day 180)