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

NCT ID: NCT06807892

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-12
• Study Completion Date: 2027-10-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Synergistic management

Group Type: ACTIVE_COMPARATOR

Synergistic management

Intervention Type: OTHER

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

Sequential management

Group Type: ACTIVE_COMPARATOR

Sequential management

Intervention Type: OTHER

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

Interventions

Synergistic management

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

Intervention Type: OTHER

Sequential management

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Angers University hospital

Anngers, , France

Countries

France

Central Contacts

Clarisse SCHERER GAGOU, MD

Role: CONTACT

ClScherer@chu-angers.fr

02 41 35 55 46 ext. +33

Facility Contacts

Clarisse SCHERER GAGOU, MD

Role: primary

ClScherer@chu-angers.fr

02 41 35 55 46 ext. +33

Other Identifiers

49RC25_0024

Identifier Type: -

Identifier Source: org_study_id