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

U

University Hospital, Angers

Status

Not yet enrolling

Conditions

Exergame
Huntington's Disease (HD)

Treatments

Other: Synergistic management
Other: Sequential management

Study type

Interventional

Funder types

Other

Identifiers

NCT06807892
49RC25_0024

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Synergistic management
Active Comparator group
Treatment:
Other: Synergistic management
Sequential management
Active Comparator group
Treatment:
Other: Sequential management

Trial contacts and locations

1

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Central trial contact

Clarisse SCHERER GAGOU, MD

Data sourced from clinicaltrials.gov

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