A Rehabilitation Program to Increase Balance and Mobility in Ataxia of Charlevoix-Saguenay

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

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.

Study Overview

• Status: Completed
• Conditions: Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
• Intervention / Treatment: Other: Training program

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Saguenay, Quebec, Canada, G7X 7X2
      • Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training program; 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.	Other: Training program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, week 4, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in walking speed	Change in the walking speed, measured with the time to walk 10 meters at comfortable and maximum speed	Baseline, week 4, week 8
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	Baseline, week 4, week 8
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.	Baseline, week 4, week 8
Change in balance	Measured with the Berg Balance Scale, score range 0-56, a higher score indicates better balance.	Baseline, week 4, week 8
Change in sitting balance	Measured with the Ottawa sitting scale, score range 0-40, a higher score indicates a better outcome.	Baseline, week 4, week 8
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.	Baseline, week 4, week 8

Collaborators and Investigators

• Sponsor: Élise Duchesne
• Collaborators: Muscular Dystrophy Canada
• Investigators: Principal Investigator: Cynthia Gagnon, PhD, Sherbrooke University

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): July 12, 2019
• Study Completion (Actual): July 12, 2019

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Musculoskeletal Diseases; Muscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Dyskinesias; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Muscle Hypertonia; Cerebellar Diseases; Spinocerebellar Degenerations; Ataxia; Muscle Spasticity; Cerebellar Ataxia; Spinocerebellar Ataxias
• Other Study ID Numbers: 2019-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No