CClinicalTrials.gg
CompletedNCT05479656Updated May 24, 2023

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

An interventional study of Training program in Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay, sponsored by Élise Duchesne. Completed at 1 site in Canada. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Élise Duchesne · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled May 2019, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 10 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Élise Duchesne is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Having other medical diagnosis causing physical limitations
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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

Interventions

  • OtherTraining 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, week 4, week 8

Secondary outcomes

  1. Change in walking speed

    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

  2. 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

    Time frame: Baseline, week 4, week 8

  3. 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.

    Time frame: Baseline, week 4, week 8

  4. Change in balance

    Measured with the Berg Balance Scale, score range 0-56, a higher score indicates better balance.

    Time frame: Baseline, week 4, week 8

  5. Change in sitting balance

    Measured with the Ottawa sitting scale, score range 0-40, a higher score indicates a better outcome.

    Time frame: Baseline, week 4, week 8

  6. 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.

    Time frame: Baseline, week 4, week 8

07

Study locations

1 site
  • Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
    Saguenay, Quebec G7X 7X2, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05479656
Lead sponsor
Élise Duchesne
Collaborators
Muscular Dystrophy Canada
Responsible party
Élise Duchesne (Professor, Université de Sherbrooke) — Sponsor-investigator
First posted
Jul 29, 2022
Start date
May 13, 2019
Primary completion
Jul 12, 2019
Completion
Jul 12, 2019
Last update
May 24, 2023

Study contacts

Cynthia Gagnon, PhD
principal investigator · Sherbrooke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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