Back to resultsA Rehabilitation Program to Increase Balance and Mobility in Ataxia of Charlevoix-Saguenay
Primary Purpose
Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Training program
Sponsored by
About this trial
This is an interventional supportive care trial for Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
Eligibility Criteria
Inclusion Criteria:
- Genetically confirmed ARSACS diagnosis; walker (indoor walking abilities with or without walking aids); ability to walk 10 meters; ability to provide informed consent
Exclusion Criteria:
- Having other medical diagnosis causing physical limitations
Sites / Locations
- Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Training program
Arm Description
8-week rehabilitation program aimed at increasing trunk and lower limb motor control on balance and walking abilities, and accomplishment of activities of daily living.
Outcomes
Primary Outcome Measures
Change in the Scale for the assessement and rating of ataxia (SARA)
Measured with the Scale for the assessement and rating of ataxia (SARA), score range 0-40, higher score indicates higer ataxia severity
Secondary Outcome Measures
Change in walking speed
Change in the walking speed, measured with the time to walk 10 meters at comfortable and maximum speed
Change in the number of sit-to-stand performed in 30 seconds
Number of complete sit-to-stand performed in 30 seconds without the help of arms
Change in the balance confidence
Measured with the modified Activities-specific Balance Confidence (ABC) Scale, score range 0-100, 0 indicates no confidence and 100 is full confidence.
Change in balance
Measured with the Berg Balance Scale, score range 0-56, a higher score indicates better balance.
Change in sitting balance
Measured with the Ottawa sitting scale, score range 0-40, a higher score indicates a better outcome.
Change in the level of independence to perform daily living activities
Measured with the Barthel Index, score range 0-100, a higher score indicates a higher level of independence.
Full Information
NCT ID
NCT05479656
First Posted
July 26, 2022
Last Updated
May 22, 2023
Sponsor
Élise Duchesne
Collaborators
Muscular Dystrophy Canada
1. Study Identification
Unique Protocol Identification Number
NCT05479656
Brief Title
A Rehabilitation Program to Increase Balance and Mobility in Ataxia of Charlevoix-Saguenay
Official Title
A Better Trunk and Lower Limb Control for a Better Mobility: Assessment of a Re-entrainment Program in Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Élise Duchesne
Collaborators
Muscular Dystrophy Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This exploratory study used a pre-post test design. The supervised rehabilitation program was performed three times a week for 8 weeks (two sessions at a rehabilitation gym and one pool session). Outcome measures included Ottawa sitting scale, 30-Second Chair Stand test, Berg Balance Scale, 10-Meter Walk Test, 6-minute Walk Test, modified Activities-specific Balance Confidence Scale and SARA scale. 10 participants will complete the training program. They will be evaluated at baseline, at week 4 (miway) and after the program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training program
Arm Type
Experimental
Arm Description
8-week rehabilitation program aimed at increasing trunk and lower limb motor control on balance and walking abilities, and accomplishment of activities of daily living.
Intervention Type
Other
Intervention Name(s)
Training program
Intervention Description
8-week rehabilitation program aimed at increasing trunk and lower limb motor control on balance and walking abilities, and accomplishment of activities of daily living.
Primary Outcome Measure Information:
Title
Change in the Scale for the assessement and rating of ataxia (SARA)
Description
Measured with the Scale for the assessement and rating of ataxia (SARA), score range 0-40, higher score indicates higer ataxia severity
Time Frame
Baseline, week 4, week 8
Secondary Outcome Measure Information:
Title
Change in walking speed
Description
Change in the walking speed, measured with the time to walk 10 meters at comfortable and maximum speed
Time Frame
Baseline, week 4, week 8
Title
Change in the number of sit-to-stand performed in 30 seconds
Description
Number of complete sit-to-stand performed in 30 seconds without the help of arms
Time Frame
Baseline, week 4, week 8
Title
Change in the balance confidence
Description
Measured with the modified Activities-specific Balance Confidence (ABC) Scale, score range 0-100, 0 indicates no confidence and 100 is full confidence.
Time Frame
Baseline, week 4, week 8
Title
Change in balance
Description
Measured with the Berg Balance Scale, score range 0-56, a higher score indicates better balance.
Time Frame
Baseline, week 4, week 8
Title
Change in sitting balance
Description
Measured with the Ottawa sitting scale, score range 0-40, a higher score indicates a better outcome.
Time Frame
Baseline, week 4, week 8
Title
Change in the level of independence to perform daily living activities
Description
Measured with the Barthel Index, score range 0-100, a higher score indicates a higher level of independence.
Time Frame
Baseline, week 4, week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Genetically confirmed ARSACS diagnosis; walker (indoor walking abilities with or without walking aids); ability to walk 10 meters; ability to provide informed consent
Exclusion Criteria:
Having other medical diagnosis causing physical limitations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Gagnon, PhD
Organizational Affiliation
Sherbrooke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
City
Saguenay
State/Province
Quebec
ZIP/Postal Code
G7X 7X2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Rehabilitation Program to Increase Balance and Mobility in Ataxia of Charlevoix-Saguenay
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