NCT05479656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

July 26, 2022

Last Update Submit

May 22, 2023

Conditions

Outcome Measures

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

    Baseline, week 4, week 8

Secondary Outcomes (6)

  • Change in walking speed

    Baseline, week 4, week 8

  • Change in the number of sit-to-stand performed in 30 seconds

    Baseline, week 4, week 8

  • Change in the balance confidence

    Baseline, week 4, week 8

  • Change in balance

    Baseline, week 4, week 8

  • Change in sitting balance

    Baseline, week 4, week 8

  • +1 more secondary outcomes

Study Arms (1)

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.

Other: Training program

Interventions

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.

Training program

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Genetically confirmed ARSACS diagnosis; walker (indoor walking abilities with or without walking aids); ability to walk 10 meters; ability to provide informed consent

You may not qualify if:

  • Having other medical diagnosis causing physical limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe de recherche interdisciplinaire sur les maladies neuromusculaires

Saguenay, Quebec, G7X 7X2, Canada

Location

MeSH Terms

Conditions

Spastic ataxia Charlevoix-Saguenay type

Study Officials

  • Cynthia Gagnon, PhD

    Sherbrooke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 26, 2022

First Posted

July 29, 2022

Study Start

May 13, 2019

Primary Completion

July 12, 2019

Study Completion

July 12, 2019

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations