Autosomal Recessive Spastic Ataxia of Charlevoix-SaguenayNCT06261424
Effects of a Supervised Rehabilitation Program on Disease Severity in Spastic Ataxias
A study testing IMPACT - rehabIlitation prograM for sPAstiC aTaxias in people with Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay and Spastic Paraplegia 7, run by Laval University at 5 sites in Canada.
Trial summary
Spastic ataxias are a group of diseases causing symptoms such as walking difficulties and balance impairments that lead to a high risk of falls. No pharmacological treatments exist to treat these diseases. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay, Spastic Paraplegia 7
- What is being tested?
- IMPACT - rehabIlitation prograM for sPAstiC aTaxias
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Feb 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- have a confirmed genetic diagnosis of ARSACS or SPG7
- be able to maintain standing position and to transfert
- be authorized by their treating neurologist
- speak French or English
- be able to give informed consent.
Who cannot join
- have active participation in a rehabilitation program (self-reported information)
- have another condition causing physical limitations
- be uncomfortable in a swimming pool
- be pregnant.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Not yet recruiting
CIUSSS de la Capitale-Nationale, Hôpital de Baie-Saint-Paul
Baie-Saint-Paul, Quebec, G3Z 0K3
Élise Duchesne, Ph. D., educhesn@uqac.ca
Jacques Beaulieu, commissaire local aux plaintes, commissaire.plainte.ciussscn@ssss.gouv.qc.ca
- Not yet recruiting
CIUSSS de la Capitale-Nationale, Hôpital de La Malbaie
La Malbaie, Quebec, G5A 1T1
Élise Duchesne, Ph. D., educhesn@uqac.ca
Jacques Beaulieu, commissaire local aux plaintes, commissaire.plainte.ciussscn@ssss.gouv.qc.ca
- Recruiting
CIUSSS du Centre-Sud-de-l'Île-de-Montréal, installation Centre de réadaptation Lucie-Bruneau
Montreal, Quebec, H2H 2N8
Élise Duchesne, Ph. D., educhesn@uqac.ca
Céline Roy, commissaire local aux plaintes, 514-593-3600, commissaireauxplaintes.ccsmtl@ssss.gouv.qc.ca
- Recruiting
CIUSSS de la Capitale-Nationale, installation IRDPQ
Québec, Quebec, G1M 2S8
Élise Duchesne, Ph. D., 418-590-3552
Jacques Beaulieu, commissaire local aux plaintes, commissaire.plainte.ciussscn@ssss.gouv.qc.ca
- Recruiting
Clinique des maladies neuromusculaires du Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Saguenay-Lac-Saint-Jean, installation Hôpital Jonquière
Saguenay, Quebec, G7X 7X2
Élise Duchesne, 418-590-3552, educhesn@uqac.ca
Julie Bouchard, commissaire local aux plaintes, 1 877 662-3963, guichetunique.slsj@ssss.gouv.qc.ca
About this study
Official title: IMPACT, a Supervised Rehabilitation Program for Spastic Ataxias: A Rater-blinded, Randomized Controlled Trial
Spastic ataxias are a group of diseases causing symptoms such as walking difficulties and balance impairments that lead to a high risk of falls. No pharmacological treatments exist to treat these diseases. Unfortunately, little effort is made to develop non-pharmacological treatments specific to spastic ataxias despite the detrimental impact of the disease on several aspects of an individual's life and the high cost of falls for society each year. The three objectives of this project are: 1) to determine the effect of a 12-week rehabilitation program on disease severity as compared with usual care for individuals with spastic ataxias; 2) to identify which factors can help (or not) the implementation of the program in the clinical settings ("reel world"); and 3) to explore the cost-benefits of IMPACT [rehabIlitation prograM for sPAstiC aTaxias]. The team has developed the program to specifically target symptoms present in these patients and was previously pilot-tested. Based on the results obtained in this pilot project, positive effects are expected concerning the disease severity of participants. The investigators want, with this project, provide to health care professionals an option to offer better-suited services to people living with spastic ataxia worldwide.
- Being tested
- IMPACT - rehabIlitation prograM for sPAstiC aTaxias
- Medical subject headings
- Spastic ataxia Charlevoix-Saguenay type, Spastic Paraplegia Type 7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACT - rehabIlitation prograM for sPAstiC aTaxiasProcedure or surgery
The rehabilitation program will last 12 weeks and consists of three training sessions of 60 minutes per week (2 sessions in a therapy room and 1 session in an adapted pool with multiple levels of water) for a total of 36 sessions. Participants will be divided into 7 subgroups of 6 participants and each sub-group will be supervised by one physiotherapist (PT) and one physiotherapy technologist for safety considerations. It will focus on these three domains: 1) postural control; balance, trunk-limbs and multi-joints control and coordination and 3) functional mobility. Each domain contains a standardized list of exercises with different difficulty levels and specific times allocation. All exercises will be executed by the participants at each session at the appropriate difficulty level. The initial level of difficulty for each exercise will be determined by the PT based on individual results of the pre-intervention assessment and on individual performance, fatigue level and safety.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will receive their usual care and will be asked to continue their usual activities and exercises for the whole project duration. Only one clinical guide exists for ataxia interventions and no specific guidelines for physiotherapy and occupational therapy interventions are specified in this guide in terms of frequency, duration and type of interventions that are effective with this population. Patients generally have an annual follow-up with a doctor or a clinical nurse at a Neuromuscular Diseases Clinic. Patients are then referred if needed for follow-up with the physiotherapist and occupational therapist. Typically, patients are referred to physiotherapy for mobility-related needs such as the introduction of a walking aid, orthotic and sometimes teaching an exercise program. In occupational therapy, patients are referred for needs such as the introduction of technical aids, home adaptation or the introduction of a wheelchair. |
| Intervention group | Experimental | The intervention group will follow a 12-week rehabilitation program, 3 times a week (two sessions in a therapy room and one session of aquatherapy). Receives: Procedure: IMPACT - rehabIlitation prograM for sPAstiC aTaxias |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of ataxia
The severity of ataxia assessed using the Scale for the assessment and rating of Ataxia (SARA) has been chosen as the main variable based on several considerations. 1) it is one of the most widely used scales among recessive cerebellar ataxias in intervention studies, 2) it includes lower limbs motor impairments-induced mobility limitations items, 3) is significantly correlated with key impairments variables such as standing balance and walking speed, 4) and is a candidate for outcome measurement in foreseeable clinical trials.
It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia) It showed evidence of adequate content validity and excellent construct validity and internal consistency in ARSACS and we recently validated the French version.
Measured: 64 weeks
Secondary outcomes (36)
Medication change
Patients will be asked about the possibility of changing their medication. A list of medications will also be provided by the pharmacy.
Measured: 64 weeks
Weight
Patients weight in kilograms
Measured: 64 weeks
height
Patients height in meters
Measured: 64 weeks
Physical activities
The Rapid Assessment of Physical Activity (RAPA) is a questionnaire used to assess physical activity levels.
Each question has a 'Yes' or 'No' option. The total score of the first seven items is out of 7; participants choose which question corresponds to their activity level. Any score less than 6 is considered suboptimal. Strength training and flexibility are scored separately (strength training = 1, flexibility = 2, both = 3)
Measured: 64 weeks
Walking speed.
The 10-meter walk test will be used to assess the short-distance walking speed at comfortable and maximum speeds. The validity and reliability of the 10mWT are both excellent in ARSACS (ICC = 0.99).
Measured: 64 weeks
Standing balance
Berg balance scale will be used to assess balance and risk of falling. Its validity has been demonstrated in ARSACS.18 Participants' level of confidence in their balance will be assessed using the simplified balance confidence scale specific to daily activities
It has 14 (0-4) categories with accumulative score ranging from 0 to 56. Interpretation: 0-20, wheelchair bound; 21-40, walking with assistance; 41-56, independent.
Measured: 64 weeks
Balance confidence
Activities specific balance confidence-simplified (ABC-S) scale will aslo be use to assess balance (0-3 likert scale) This questionnaire includes 15 evaluation items, rated from 0 (not at all confident) to 3 (very confident), according to the person's confidence in maintaining their balance when performing various activities. The total score ranges from 0 (minimum confidence) to 45 (maximum confidence), and is obtained by adding together the scores for each item and converting them into a percentage.
Measured: 64 weeks
Sitting balance
Sitting balance and trunk control will be assessed with the Ottawa sitting scale (OSS).
The first six items are tested with the participant's feet on the ground ( /24) and the next six with the feet off the ground ( /24). The total score is calculated by adding together the scores for the two subsections (maximum score out of /48).
Measured: 64 weeks
Activities of Daily Living
The Barthel Index will assess the level of independence in performing daily living activities.
Measured: 64 weeks
Muscle tone
Lower limb muscle tone (spasticity) will be measured with the modified Ashworth scale.
Score each muscle group evaluated according to the table below. *Scoring is performed within the available range of motion. 0: No increase in muscle tone. 1: Discrete increase in muscle tone manifested by a twitch followed by release or by minimal resistance at the end of the movement. 1+: Discrete increase in muscle tone manifested by a twitch followed by minimal resistance perceived over less than half the joint amplitude. 2: More marked increase in muscle tone affecting most of the joint amplitude, the joint being easily mobilized. 3: Significant increase in muscle tone making passive mobilization difficult. 4: Affected joint is fixed (no passive movement possible).
Measured: 64 weeks
Life habits
The Assessment of Life Habits Questionnaire 4.0. (LIFE-H) was used to assess participation. It includes a total of 96 activities with one total score, two subscores (daily activities and social activities) and 12 domains divided equally between both subscores. For each activity, the level of accomplishment, type of assistance required and level of satisfaction are rated. Accomplishment includes the difficulty level and assistance required: a mean score of "0" refers to a complete disruption of participation (i.e. activity not accomplished), and "10" refers to full participation (i.e. activity accomplished without difficulty and assistance). The satisfaction level is measured on a 4-point scale, where a higher score indicates higher satisfaction ("4"). For the 3.0 version, a change of 0.5 (/9) is considered a minimal clinically important difference but is not documented for the version 4.0.
Measured: 64 weeks
Community mobility
The daily rest-activity pattern will be assessed using an ActiGraph wGT3X-BT activity monitor worn on the nondominant arm for 7 consecutive days before and after the intervention period. Intradaily variability and interdaily stability (IS), M10 (most active 10-hours), L5 (least active 5-hours), and relative amplitude (RA) will be derived using nonparametric rhythm analysis. The patient's perception of mobility limitations will be measured by the Life Space Assessment questionnaire.
Measured: 7 consecutives days, 2 times
Plasma
3 x 10ml EDTA tubes will be collected to obtain 6 x 0.5ml cryovials of plasma (protein)
Measured: 64 weeks
DNA
3 x 10ml EDTA tubes will be collected to obtain 3 x 2ml cryovials of Buffy Coat (DNA).
Measured: 64 weeks
Serum
3 x 5ml SST serum tubes will be collected to obtain 12 x 0.5ml serum (protein) cryovials.
Measured: 64 weeks
RNA
3 PAXgene 2.5ml tubes (RNA) will be collected and frozen as is.
Measured: 64 weeks
Urine
10 ml of urine will be collected and separated into 12 cryovials of 0.5 ml.
Measured: 64 weeks
Saliva
12 ml of saliva will be collected to obtain 12 cryovials of 0.5 ml.
Measured: 64 weeks
Mobility Life-space
Life-Space Assessment (LSA-F) is a 20-items questionnaire measures the extent of mobility, taking into account the person's interactions with the environment. It assesses mobility habits in five living environments: the rooms of the home (or living unit for people living in sheltered housing), the surroundings of the home (or living unit/housing environment), the neighborhood, the city and outside the city.
Mobility area - Composite score, which is obtained by combining the level of mobility area achieved, the frequency of travel in each mobility area and the assistance required (technical aid and/or assistance of a person) to get there. The score ranges from 0 to 120, where 120 corresponds to an unrestricted mobility area.
Measured: 64 weeks
Ataxia impact scale
Person-reported ataxia impact scale (PRAIS) is self-administered questionnaire consists of 38 questions and aims to understand the impact of ataxia on daily life. A score out of 100 results.
Measured: 64 weeks
Lower limb coordination
It will be measured using the Lower Extremity Motor Coordination Test. It is a reliable tool in ARSACS (ICC = 0.82-0.99).
Measured: 64 weeks
Peak respiratory flow and cough
Peak expiratory flow (PEF) is the maximum speed at which air can be expelled from the lungs during forced expiration.
Measured: 64 weeks
Fatigue
Fatigue will be assess with the Fatigue Severity Scale (FSS) This scale is a method of assessing the impact of fatigue on the subject. It is a short questionnaire that assesses the level of fatigue. The questionnaire contains nine statements that assess the severity of fatigue symptoms on a 7-level likert scale and produce a score between 9 and 63. A high score is a sign of fatigue
Measured: 64 weeks
Falls.
The fall history with and without injury will be self-reported according to the recommendations of the group of Elley et al. Participants will have to complete every day a fall logbook and a research assistant will contact them each month to document the circumstances and consequences of falls including injuries and medical consultations.
Measured: 64 weeks
Patient-reported impression of change.
The patients-global impression of change will be used (3 questions, 7-level Likert self-reported scale) to assess the impression of change.It is sensitive to change. This questionnaire gives the patient's perception. The higher the score, the worse the situation.
Measured: 64 weeks
Anxiety and Depression
Hospital Anxiety and Depression scale will assess anxiety and Depression
The HADS is a screening instrument for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven to depression (total D), giving two scores (maximum score for each = 21).
Measured: 64 weeks
Pain characteristics
Brief Pain Inventory Short Form
Measured: 64 weeks
Functional lower extremity strength
The 30CST is a measurement that assesses functional lower extremity strength. The total number of correctly performed sit-to-stand repetitions is counted. If the participant is more than halfway upright when the 30 seconds have elapsed, count this as a repetition. If the participant is unable or unwilling to perform the test correctly, enter "0 repetitions" for each trial on the scoring sheet. The validity of the result of each test must be entered on the scoring sheet (valid or invalid).
Measured: 64 weeks
Focus group with intervention group participants
Each participant will take part in one focus group after the rehabilitation program. Also, a semi-structured interview guide covering the 7 dimensions of the TFA will be used.
Measured: 1 day
Focus groups with stakeholders
One focus group per site will be conducted before and after the intervention. In addition, during the rehabilitation program, each PT will be asked to fill out a journal of observations every week that includes the CFIR intervention items. In addition, the Determinant of Implementation Behavior. Questionnaire will be administered to PT and assistants at T0 and T3.
Measured: 12 weeks
Lower limb muscle activation
It will be measured using surface EMG. Surface myoelectric signals will be recorded at 2000 HZ using a 16-channel wireless system (Trigno™ EMG, Delsys, MA, USA).
Measured: 64 weeks
Quality of life
Quality of life will be assessed with SF-12 is a generic questionnaire that assesses health-related quality of life from the participant's point of view. It can be self-administered or completed during an interview. It comprises 12 assessment items, divided into 7 domains. The scoring system provides two quality-of-life scores (0 to 100: poor to excellent), i.e., a subtotal for mental and social quality of life (MCS) and a subtotal for physical quality of life (PCS).
Measured: 64 weeks
CBA analyses and Willingness to pay
Estimating the costs related to the use of health services, falls with and without injuries, and improvement in quality of life and our health indicators (main and secondary outcomes). Using data collected in medical records and the hospitalization data, we will use different variables to take into account the use of health services such as: 1) visits physicians or health care professionals; 2) home visits by home-care professionals; and 3) emergency or hospital stays. We will also use the project's information relative to the cost of the rehabilitation program such as: 1) the number of hours of assessments and supervision of the program/type of professional and 2) the hourly rate of professionals. The cost of setting up a rehabilitation program will be estimated by combining human and material resources.
Measured: 64 weeks
Gait's temporal parameters
The GAITRite system is a 14ft carpet containing sensors activated by pressure exerted by the feet and providing x and y coordinates. Then, the footprint analysis can provides the gait temporal parameters such as step time, step length, cadence and speed.
Measured: 64 weeks
Stance balance
Force platform
Measured: 64 weeks
Postural balance
Postural balance will be assess with the wobble chair. This test measures the postural balance of the trunk during a balance task in a seated position on an unstable chair, where only movements of the lumbar spine are allowed to restore balance.
Measured: 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Feb 2024
- Primary completionApr 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autosomal Recessive Spastic Ataxia of Charlevoix-SaguenayStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicentre and controlled trial design.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Université de Sherbrooke, Université du Québec a Montréal, University of Calgary, Corporation de recherche et d'action sur les maladies héréditaires (CORAMH), Cégep de Jonquière, Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-St-Jean, Muscular Dystrophy Canada, University of Alberta, Integrated University Health and Social Services Center of the Capitale-Nationale
- Responsible party
- Principal investigator, Elise Duchesne, Laval University
- Investigators
- Elise Duchesne, Ph D., Study director, Université du Québec à Chicoutimi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261424
- Sponsor's protocol ID
- 2024-1426
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All information collected as part of this research project, as research data including biological material, will be stored securely in the data bank Banque de données et de matériel biologique des maladies neuromusculaires et autres maladies et conditions apparentées (BDMB-MNM-MCA). All research data of participants, including biological material, will be used by researchers to carry out research projects on neuromuscular and related diseases.
Publications
Lessard I, Masterman V, Cote I, Gagnon C, Duchesne E. A rehabilitation program to increase balance and mobility in ataxia of Charlevoix-Saguenay: An exploratory study. PLoS One. 2022 Dec 28;17(12):e0279406. doi: 10.1371/journal.pone.0279406. eCollection 2022.
PubMed 36576926
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT, a Supervised Rehabilitation Program for Spastic Ataxias: A Rater-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06261424
- Acronym / sponsor ID
- 2024-1426
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- McGill University, Université de Sherbrooke, Université du Québec a Montréal, University of Calgary, Corporation de recherche et d'action sur les maladies héréditaires (CORAMH), Cégep de Jonquière, Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-St-Jean, Muscular Dystrophy Canada, University of Alberta, Integrated University Health and Social Services Center of the Capitale-Nationale
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Feb 2024 (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.
Spastic ataxias are a group of diseases causing symptoms such as walking difficulties and balance impairments that lead to a high risk of falls. No pharmacological treatments exist to treat these diseases. Unfortunately, little effort is made to develop non-pharmacological treatments specific to spastic ataxias despite the detrimental impact of the disease on several aspects of an individual's life and the high cost of falls for society each year. The three objectives of this project are: 1) to determine the effect of a 12-week rehabilitation program on disease severity as compared with usual care for individuals with spastic ataxias; 2) to identify which factors can help (or not) the implementation of the program in the clinical settings ("reel world"); and 3) to explore the cost-benefits of IMPACT [rehabIlitation prograM for sPAstiC aTaxias]. The team has developed the program to specifically target symptoms present in these patients and was previously pilot-tested. Based on the results obtained in this pilot project, positive effects are expected concerning the disease severity of participants. The investigators want, with this project, provide to health care professionals an option to offer better-suited services to people living with spastic ataxia worldwide.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- A multicentre and controlled trial design.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will receive their usual care and will be asked to continue their usual activities and exercises for the whole project duration. Only one clinical guide exists for ataxia interventions and no specific guidelines for physiotherapy and occupational therapy interventions are specified in this guide in terms of frequency, duration and type of interventions that are effective with this population. Patients generally have an annual follow-up with a doctor or a clinical nurse at a Neuromuscular Diseases Clinic. Patients are then referred if needed for follow-up with the physiotherapist and occupational therapist. Typically, patients are referred to physiotherapy for mobility-related needs such as the introduction of a walking aid, orthotic and sometimes teaching an exercise program. In occupational therapy, patients are referred for needs such as the introduction of technical aids, home adaptation or the introduction of a wheelchair. |
| Intervention group | Experimental | Procedure: IMPACT - rehabIlitation prograM for sPAstiC aTaxiasThe intervention group will follow a 12-week rehabilitation program, 3 times a week (two sessions in a therapy room and one session of aquatherapy). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- have a confirmed genetic diagnosis of ARSACS or SPG7
- be able to maintain standing position and to transfert
- be authorized by their treating neurologist
- speak French or English
- be able to give informed consent.
Key exclusion criteria (4 listed)
- have active participation in a rehabilitation program (self-reported information)
- have another condition causing physical limitations
- be uncomfortable in a swimming pool
- be pregnant.
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 |
|---|---|---|
| IMPACT - rehabIlitation prograM for sPAstiC aTaxiasThe rehabilitation program will last 12 weeks and consists of three training sessions of 60 minutes per week (2 sessions in a therapy room and 1 session in an adapted pool with multiple levels of water) for a total of 36 sessions. Participants will be divided into 7 subgroups of 6 participants and each sub-group will be supervised by one physiotherapist (PT) and one physiotherapy technologist for safety considerations. It will focus on these three domains: 1) postural control; balance, trunk-limbs and multi-joints control and coordination and 3) functional mobility. Each domain contains a standardized list of exercises with different difficulty levels and specific times allocation. All exercises will be executed by the participants at each session at the appropriate difficulty level. The initial level of difficulty for each exercise will be determined by the PT based on individual results of the pre-intervention assessment and on individual performance, fatigue level and safety. | Procedure or surgery | Intervention group |
Primary outcome
Severity of ataxia
Time frame: 64 weeks
The severity of ataxia assessed using the Scale for the assessment and rating of Ataxia (SARA) has been chosen as the main variable based on several considerations. 1) it is one of the most widely used scales among recessive cerebellar ataxias in intervention studies, 2) it includes lower limbs motor impairments-induced mobility limitations items, 3) is significantly correlated with key impairments variables such as standing balance and walking speed, 4) and is a candidate for outcome measurement in foreseeable clinical trials. It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia) It showed evidence of adequate content validity and excellent construct validity and internal consistency in ARSACS and we recently validated the French version.
36 secondary outcomes
Medication change
Time frame: 64 weeks
Weight
Time frame: 64 weeks
height
Time frame: 64 weeks
Physical activities
Time frame: 64 weeks
Walking speed.
Time frame: 64 weeks
Standing balance
Time frame: 64 weeks
Balance confidence
Time frame: 64 weeks
Sitting balance
Time frame: 64 weeks
Activities of Daily Living
Time frame: 64 weeks
Muscle tone
Time frame: 64 weeks
Life habits
Time frame: 64 weeks
Community mobility
Time frame: 7 consecutives days, 2 times
Plasma
Time frame: 64 weeks
DNA
Time frame: 64 weeks
Serum
Time frame: 64 weeks
RNA
Time frame: 64 weeks
Urine
Time frame: 64 weeks
Saliva
Time frame: 64 weeks
Mobility Life-space
Time frame: 64 weeks
Ataxia impact scale
Time frame: 64 weeks
Lower limb coordination
Time frame: 64 weeks
Peak respiratory flow and cough
Time frame: 64 weeks
Fatigue
Time frame: 64 weeks
Falls.
Time frame: 64 weeks
Patient-reported impression of change.
Time frame: 64 weeks
Anxiety and Depression
Time frame: 64 weeks
Pain characteristics
Time frame: 64 weeks
Functional lower extremity strength
Time frame: 64 weeks
Focus group with intervention group participants
Time frame: 1 day
Focus groups with stakeholders
Time frame: 12 weeks
Lower limb muscle activation
Time frame: 64 weeks
Quality of life
Time frame: 64 weeks
CBA analyses and Willingness to pay
Time frame: 64 weeks
Gait's temporal parameters
Time frame: 64 weeks
Stance balance
Time frame: 64 weeks
Postural balance
Time frame: 64 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 36576926Lessard I, Masterman V, Cote I, Gagnon C, Duchesne E. A rehabilitation program to increase balance and mobility in ataxia of Charlevoix-Saguenay: An exploratory study. PLoS One. 2022 Dec 28;17(12):e0279406. doi: 10.1371/journal.pone.0279406. eCollection 2022.
- Individual participant dataSharing planned: Yes. All information collected as part of this research project, as research data including biological material, will be stored securely in the data bank Banque de données et de matériel biologique des maladies neuromusculaires et autres maladies et conditions apparentées (BDMB-MNM-MCA). All research data of participants, including biological material, will be used by researchers to carry out research projects on neuromuscular and related diseases.
Related trials for Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Elise Duchesne, Ph D. study director
Université du Québec à Chicoutimi
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPACT - rehabIlitation prograM for sPAstiC aTaxias in people with Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay and Spastic Paraplegia 7, run by Laval University at 5 sites 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise Duchesne, Ph D. (418-590-3552, educhesn@uqac.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of ataxia (time frame: 64 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06261424, which also lists 1 linked publication.
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 18 Feb 2026.