A Home-based Rehabilitation Program to Counter the Motor Impairments and Activity Limitations Experienced by People With Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Université de Sherbrooke
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Change in sitting balance
Study Overview
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.
Detailed Description
Co-creation phase:
Preceding the intervention, a co-creation phase involving healthcare professionals (3), patient-partners (2), and ARSACS researchers (3) will be conducted to develop the exercises for the rehabilitation program and the evaluation scale to determine the level of difficulty of each exercise assigned to participants.
Intervention phase:
Random sampling stratified by gender and level of indoor mobility (unassisted walking, assisted walking, wheelchair) from the Neuromuscular Clinic's registry of 48 participants (24 women and 24 men) will be conducted.
- Control phase: All participants will be asked to maintain their usual activities for 12 weeks.
- Intervention phase: All participants recruited to the project will complete the home-based rehabilitation program assigned to them for 12 weeks, unsupervised, 20 minutes 3 times a week. Follow-up calls by a physiotherapist will be conducted at weeks 2, 4, 6, 8, 10 and 12.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Rehabilitation (Other)
Outcomes
Primary Outcomes
Change in sitting balance
Time Frame: Baseline, week 12, week 24
Measured with the Ottawa sitting scale, score range 0-40, a higher score indicates a better outcome
Change in walking speed
Time Frame: Baseline, week 12, week 24
Change in the walking speed, measured with the time to walk 10 meters at self-selected and maximum speed
Change in balance
Time Frame: Baseline, week 12, week 24
Measured with the Berg Balance Scale, score range 0-56, a higher score indicates better balance
Secondary Outcomes
- Sum of lower limb muscle spasticity(Baseline, week 12, week 24)
- Change in the time required to descent 10 stairs(Baseline, week 12, week 24)
- Change in the balance confidence(Baseline, week 12, week 24)
- Change in the number of falls(Baseline, week 12, week 24)
- Change in mobility components(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)
- Change in social participation(Baseline, week 12, week 24)
- Change in the knee extensor muscle group spasticity(Baseline, week 12, week 24)
- Change in the life space(Baseline, week 12, week 24)
- Change in the upper limb coordination(Baseline, week 12, week 24)
- Measure of the usability of the program and hardware(Week 24)
- Change in the adductor hip muscle group spasticity(Baseline, week 12, week 24)
- Change in the plantar flexor muscle group spasticity(Baseline, week 12, week 24)
- Change in the knee flexor muscle group spasticity(Baseline, week 12, week 24)
- Change in the Scale for the assessement and rating of ataxia (SARA)(Baseline, week 12, week 24)
- Change in sleep components(Week 12, week 24)
Investigators
Cynthia Gagnon
Professor
Université de Sherbrooke