Comparison of Two Cognitive-Motor Rehabilitation Approaches Via Exergames: a Study of Cognitive, Motor and Behavioral Functions in Huntington's Disease Patients

Официальное название

CARE-MH: Comparison of Two Cognitive-Motor Rehabilitation Approaches Via Exergames: a Study of Cognitive, Motor and Behavioral Functions in Huntington's Disease Patients

Обзор

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.

Вмешательства

• Другое Synergistic management
  In synergistic management, exercises are carried out in a synergistic way: 40 minutes of exercises involving both physical and cognitive stimulation.
• Другое Sequential management
  In sequential management, exercises are performed sequentially: 20 minutes of physical exercises and 20 minutes of cognitive exercises.

Первичные конечные точки

• Berg Balance Scale (BBS) [Срок оценки: Sessions are held three times a week for 12 weeks.]

Вторичные конечные точки (12)

• L'Unified Huntington's Disease Rating Scale - Total Motor Score (UHDRS-TMS) [Срок оценки: baseline - Day 90- Day 180]
• Six-Minute Walk Test (6MWT) [Срок оценки: baseline - Day 90- Day 180]
• 30 second Chair Stand Test (30CST) [Срок оценки: baseline - Day 90- Day 180]
• Mini Mental State Examination (MMSE) [Срок оценки: baseline - Day 90- Day 180]
• The working memory subtest of the Wechsler Intelligence Scale for Adults 4th Edition (WAIS-IV, subtest "Number Memory") [Срок оценки: baseline - Day 90- Day 180]
• UHDRS cognitive tests - The Stroop test [Срок оценки: baseline - Day 90- Day 180]
• UHDRS cognitive tests - The Symbol Digit Modalities Test (SDMT) [Срок оценки: baseline - Day 90- Day 180]
• UHDRS cognitive tests - Verbal fluency task [Срок оценки: baseline - Day 90- Day 180]
• UHDRS cognitive tests - The Trail Making Test (TMT) [Срок оценки: baseline - Day 90- Day 180]
• L'Hospital Anxiety and Depression Scale (HADS) [Срок оценки: baseline - Day 90- Day 180]
• Problem Behaviours Assessment for Huntington's Disease (PBA-HD) [Срок оценки: baseline - Day 90- Day 180]
• SF- 12 self-questionnaire. [Срок оценки: baseline - Day 90- Day 180]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Angers University hospital — Angers

Идентификаторы

NCT: NCT06807892 · 49RC25_0024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗