Clinical trial NCT06807892: Comparison of Two Cognitive-Motor Rehabilitation Approaches Via Exergames: a Study of Cognitive, Motor and Behavioral Functions in Huntington's Disease Patients
Official title: CARE-MH: Comparison of Two Cognitive-Motor Rehabilitation Approaches Via Exergames: a Study of Cognitive, Motor and Behavioral Functions in Huntington's Disease Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Huntington&#39;s Disease (HD)
Exergame
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2025-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Sessions are held three times a week for 12 weeks.
Secondary outcomes:
measure: L'Unified Huntington's Disease Rating Scale - Total Motor Score (UHDRS-TMS)
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: Six-Minute Walk Test (6MWT)
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: 30 second Chair Stand Test (30CST)
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: Mini Mental State Examination (MMSE)
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: The working memory subtest of the Wechsler Intelligence Scale for Adults 4th Edition (WAIS-IV, subtest "Number Memory")
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: UHDRS cognitive tests - The Stroop test
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: UHDRS cognitive tests - The Symbol Digit Modalities Test (SDMT)
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: UHDRS cognitive tests - Verbal fluency task
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: UHDRS cognitive tests - The Trail Making Test (TMT)
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: L'Hospital Anxiety and Depression Scale (HADS)
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: Problem Behaviours Assessment for Huntington's Disease (PBA-HD)
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: SF- 12 self-questionnaire.
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: Acceptance and feasibility
timeFrame: At the beginning, at the end and 3 months after treatment.
measure: Participants' satisfaction
timeFrame: At the beginning, at the end and 3 months after treatment.
Other outcomes:
Locations:
city: Anngers
country: France
facility: Angers University hospital
Study officials:
References: