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

Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05479656
• Other study ID #: 2019-010
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: July 12, 2019

Study information

• Verified date: May 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Ataxia
• Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
• Cerebellar Ataxia
• Muscle Spasticity
• Spinocerebellar Ataxias

Intervention

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.

Locations

Country	Name	City	State
Canada	Groupe de recherche interdisciplinaire sur les maladies neuromusculaires	Saguenay	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Élise Duchesne	Muscular Dystrophy Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in balance	Measured with the Berg Balance Scale, score range 0-56, a higher score indicates better balance.	Baseline, week 4, week 8
Secondary	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
Secondary	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