Autosomal Recessive Spastic Ataxia of Charlevoix-SaguenayNCT05479656
A Rehabilitation Program to Increase Balance and Mobility in Ataxia of Charlevoix-Saguenay
A study testing Training program in people with Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay, run by Élise Duchesne at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
- What is being tested?
- Training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 13 May 2019to 12 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Genetically confirmed ARSACS diagnosis; walker (indoor walking abilities with or without walking aids); ability to walk 10 meters; ability to provide informed consent
Who cannot join
- Having other medical diagnosis causing physical limitations
Trial locations and contacts
1 site in 1 country.
Canada1 site
Groupe de recherche interdisciplinaire sur les maladies neuromusculaires
Saguenay, Quebec, G7X 7X2
About this study
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
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.
- Being tested
- Training program
- Medical subject headings
- Spastic ataxia Charlevoix-Saguenay type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Training program | Experimental | 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. Receives: Other: Training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, week 4, week 8
Secondary outcomes (6)
Change in walking speed
Change in the walking speed, measured with the time to walk 10 meters at comfortable and maximum speed
Measured: 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
Measured: 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.
Measured: Baseline, week 4, week 8
Change in balance
Measured with the Berg Balance Scale, score range 0-56, a higher score indicates better balance.
Measured: 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.
Measured: 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.
Measured: Baseline, week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start13 May 2019
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Recessive Spastic Ataxia of Charlevoix-SaguenayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Élise Duchesne
- Sponsor type
- University, hospital or other
- Collaborators
- Muscular Dystrophy Canada
- Responsible party
- Sponsor-investigator, Élise Duchesne, Université de Sherbrooke
- Investigators
- Cynthia Gagnon, PhD, Principal investigator, Sherbrooke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479656
- Sponsor's protocol ID
- 2019-010
- Status last verified
- May 2023
- First submitted
- 26 Jul 2022
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05479656
- Acronym / sponsor ID
- 2019-010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Élise DuchesneUniversity, hospital or other
- Collaborators
- Muscular Dystrophy Canada
- Study start
- 13 May 2019 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training program | Experimental | Other: Training program8-week rehabilitation program aimed at increasing trunk and lower limb motor control on balance and walking abilities, and accomplishment of activities of daily living. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Genetically confirmed ARSACS diagnosis; walker (indoor walking abilities with or without walking aids); ability to walk 10 meters; ability to provide informed consent
Key exclusion criteria (1 listed)
- Having other medical diagnosis causing physical limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training program8-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 |
Primary outcome
Change in the Scale for the assessement and rating of ataxia (SARA)
Time frame: Baseline, week 4, week 8
Measured with the Scale for the assessement and rating of ataxia (SARA), score range 0-40, higher score indicates higer ataxia severity
6 secondary outcomes
Change in walking speed
Time frame: Baseline, week 4, week 8
Change in the number of sit-to-stand performed in 30 seconds
Time frame: Baseline, week 4, week 8
Change in the balance confidence
Time frame: Baseline, week 4, week 8
Change in balance
Time frame: Baseline, week 4, week 8
Change in sitting balance
Time frame: Baseline, week 4, week 8
Change in the level of independence to perform daily living activities
Time frame: Baseline, week 4, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Gagnon, PhD principal investigator
Sherbrooke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training program in people with Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay, run by Élise Duchesne at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Scale for the assessement and rating of ataxia (SARA) (time frame: Baseline, week 4, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.