Recruiting

Home-based Rehabilitation

Sponsor:

Université de Sherbrooke

Code:

NCT05768750

Conditions

Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Rehabilitation

Study Details

Brief summary:

48 participants (24 women and 24 men) with autosomal recessive spastic ataxia of Charlevoix-Saguenay (ARSACS) will participate in 2 phases : control phase (12-week usual care) and intervention phase (12-week home-based rehabilitation program). The participants will be evaluated at baseline, week 12 (end of control phase) and week 24 (end of intervention phase) to quantify the effects of an individualized home-based rehabilitation program. Participants will also participate on a focus group at the end of the program to evaluate the acceptability of the program and the perceived changes.

Conditions

Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay

Study ID

NCT05768750

Start date

Dec 1, 2022

Status verified date

May, 2023

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ARSACS diagnosis must be confirmed by genetic analysis;
  • Women and men, aged between 18 and 50 years old;
  • Be able to perform the sit-to-stand transfer;
  • Consent of the neurologist must be given to participate in this study;
  • Must reside in the Saguenay-Lac-St-Jean region;
  • Subjects must be able to give their consent freely and voluntarily.

Exclusion Criteria:

  • Patients who already meet physical activity (PA) recommendations (150 min of moderate to high intensity PA/week) or already participate in a rehabilitation program are excluded;
  • Remain in a care facility;
  • Do not speak English or French;
  • Have another diagnosis causing physical limitations;
  • Are pregnant.

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Control followed by intervention phase

All participants will participate in 2 phases : control phase (12-week usual care) followed by an intervention phase (12-week home-based rehabilitation program).

The rehabilitation program consists of three domains of exercises divided by levels of difficulty: sitting balance (16 levels), standing balance (21 levels) and sit-to-stand transfer (12 levels), including 67 exercises. Each individualized home-based rehabilitation program will include 3 to 6 exercises, for a total duration of 15 to 20 minutes.

Interventions

Rehabilitation

X

Primary outcome measure

  • Change in sitting balance [ Time Frame: Baseline, week 12, week 24 ]
  • Change in balance [ Time Frame: Baseline, week 12, week 24 ]
  • Change in walking speed [ Time Frame: Baseline, week 12, week 24 ]

Central Contacts and Locations

Central contacts

Elise Duchesne, Ph.D

418-545-5011elise1_duchesne@uqac.ca

Locations

Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

Recruiting

Saguenay, Quebec, Canada, G7X 7X2

Contacts

Elise Duchesne, Ph.D.

418-545-5011elise1_duchesne@uqac.ca

Principal Investigator:

Elise Duchesne, Ph.D.

More Information

Sponsor

Université de Sherbrooke

Last update posted

May 25, 2023

Last verified

May, 2023

Keywords

  • ARSACS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2023-05-25.