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

NCT06807892 | Recruiting

• 1 other identifier: 49RC25_0024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Huntington's Disease (HD); Exergame

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale (BBS)

  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

  Sessions are held three times a week for 12 weeks.

Secondary Outcomes (14)

• 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

• The working memory subtest of the Wechsler Intelligence Scale for Adults 4th Edition (WAIS-IV, subtest "Number Memory")

  baseline - Day 90- Day 180

Study Arms (2)

Synergistic management

ACTIVE COMPARATOR

Other: Synergistic management

Sequential management

ACTIVE COMPARATOR

Other: Sequential management

Interventions

Synergistic management OTHER

In synergistic management, exercises are carried out in a synergistic way: 40 minutes of exercises involving both physical and cognitive stimulation.

Synergistic management

Sequential management OTHER

In sequential management, exercises are performed sequentially: 20 minutes of physical exercises and 20 minutes of cognitive exercises.

Sequential management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers University hospital

Angers, France

RECRUITING

Central Study Contacts

Clarisse SCHERER GAGOU, MD

CONTACT

+33 2 41 35 55 46; ClScherer@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 4, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): October 17, 2027
• Study Completion (Estimated): October 17, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)