A Home-based Rehabilitation in ARSACS

NCT05768750 | Unknown

• 1 other identifier: 2021-047
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

ARSACS

Outcome Measures

Primary Outcomes (3)

• Change in sitting balance

  Measured with the Ottawa sitting scale, score range 0-40, a higher score indicates a better outcome

  Baseline, week 12, week 24

• Change in balance

  Measured with the Berg Balance Scale, score range 0-56, a higher score indicates better balance

  Baseline, week 12, week 24

• Change in walking speed

  Change in the walking speed, measured with the time to walk 10 meters at self-selected and maximum speed

  Baseline, week 12, week 24

Secondary Outcomes (18)

• Change in the balance confidence

  Baseline, week 12, week 24

• Change in the number of falls

  Baseline, week 12, week 24

• Change in the lower limb coordination

  Baseline, week 12, week 24

• Change in the number of sit-to-stand performed in 30 seconds

  Baseline, week 12, week 24

• Change in the time required to ascent 10 stairs

  Baseline, week 12, week 24

Study Arms (1)

Control followed by intervention phase

EXPERIMENTAL

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.

Other: Rehabilitation

Interventions

Rehabilitation OTHER

X

Control followed by intervention phase

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

Saguenay, Quebec, G7X 7X2, Canada

RECRUITING

MeSH Terms

Conditions

Spastic ataxia Charlevoix-Saguenay type

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Elise Duchesne, Ph.D

  Université du Québec à Chicoutimi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise Duchesne, Ph.D

CONTACT

418-545-5011; elise1_duchesne@uqac.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 14, 2023
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

CA (1)