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Recruiting NCT06807892

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

No phase Interventional Huntington's Disease (HD) Exergame

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Synergistic management, Sequential management.
Who it may be relevant to
Registry conditions: Huntington's Disease (HD), Exergame. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Angers University hospital — Angers

Identifiers

NCT: NCT06807892 · 49RC25_0024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗