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Home-Based Rehabilitation for ARSACS (PACE-ARSCS Trial)
N/A
Recruiting
Led By Elise Duchesne, Ph.D
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ARSACS diagnosis must be confirmed by genetic analysis
Women and men, aged between 18 and 50 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12, week 24
Awards & highlights
PACE-ARSCS Trial Summary
This trial will test the effects of a 12-week home-based rehab program on 48 people with ARSACS, measuring changes & acceptability at 3 points.
Who is the study for?
This trial is for men and women aged 18-50 with ARSACS, a genetic disorder affecting movement. Participants must live in the Saguenay-Lac-St-Jean region, be able to stand up from a seated position, and not already be very physically active or in rehab. Pregnant individuals or those with other physical limitations are excluded.Check my eligibility
What is being tested?
The study tests a home-based rehabilitation program over 12 weeks against usual care in people with ARSACS. It involves 48 participants who will be assessed at the start, after the control phase (12 weeks), and post-intervention (24 weeks) to see how effective this individualized program is.See study design
What are the potential side effects?
Since this trial involves rehabilitation exercises tailored for individuals with ARSACS, side effects might include muscle soreness or fatigue due to increased physical activity during the intervention phase.
PACE-ARSCS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ARSACS diagnosis was confirmed through genetic testing.
Select...
I am between 18 and 50 years old.
Select...
I can sit down and stand up from a chair on my own.
PACE-ARSCS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12, week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in balance
Change in sitting balance
Change in walking speed
Secondary outcome measures
Change in mobility components
Change in sleep components
Change in social participation
+15 morePACE-ARSCS Trial Design
1Treatment groups
Experimental Treatment
Group I: Control followed by intervention phaseExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Ataxia Charlevoix-Saguenay FoundationUNKNOWN
Université de SherbrookeLead Sponsor
298 Previous Clinical Trials
69,887 Total Patients Enrolled
Elise Duchesne, Ph.DPrincipal InvestigatorUniversité du Québec à Chicoutimi
1 Previous Clinical Trials
12 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are already active for at least 150 minutes per week or participate in a rehabilitation program.I do not speak English or French.I am currently living in a care facility.You have another medical condition that limits your physical abilities.My ARSACS diagnosis was confirmed through genetic testing.I am between 18 and 50 years old.I can sit down and stand up from a chair on my own.
Research Study Groups:
This trial has the following groups:- Group 1: Control followed by intervention phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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