Spinocerebellar Ataxia Type 1PRIME-AtaxiaNCT05826171
Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia
A study testing High-Intensity Aerobic Exercise Prior to Balance Training and Low-Intensity Exercise Prior to Balance Training in people with Spinocerebellar Ataxia Type 1 and Spinocerebellar Ataxia Type 2, run by Teachers College, Columbia University at 1 site in United States.
Trial summary
PRIME-Ataxia is a randomized controlled trial that aims to determine the feasibility and efficacy of an 8-week telehealth intervention of high intensity aerobic exercise prior to balance training compared to an 8-week telehealth intervention of low intensity exercise prior to balance training in people with… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3
- What is being tested?
- High-Intensity Aerobic Exercise Prior to Balance Training and Low-Intensity Exercise Prior to Balance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 31 May 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18 to 85 years
- Genetically confirmed diagnosis of SCA1, 2, 3, 6, and 7
- Scale for Ataxia Rating and Assessment (SARA) score between 8-25/40, capturing mild-moderate disease
- Able to walk with/without assistive device
- Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) to confirm no medical contraindications to exercise
- Care partner availability during assessments and/or intervention pending balance scores
Who cannot join
- Severe non-ataxic motor symptoms such as dystonia, tremor, or Parkinsonism, measured by Inventory of Non-Ataxia Signs (INAS)
- Peripheral sensory loss (as confirmed with monofilament or clinical proprioceptive testing)
- Severe visual complications associated with ataxia (i.e., Spontaneous nystagmus, retinal or optic nerve involvement, especially in SCA7) defined as as have a score on the Snellen Visual Acuity test = 20/200 - 20/400, OR a visual field of 20 degrees of less.
- Musculoskeletal injury that would prevent participation in an exercise program
- Other concurrent disease of the cerebellum (e.g. stroke, multiple sclerosis)
- Cardiac/pulmonary conditions that would affect participants ability to participate exercise program
- Currently engaged in >3 week moderate-high intensity aerobic exercise and/or balance training
Trial locations and contacts
1 site in 1 country.
United States1 site
Teachers College, Columbia University
New York, New York, 10027
About this study
Official title: Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia: a Randomized Controlled Trial (PRIME-Ataxia RCT)
PRIME-Ataxia is a randomized controlled trial that aims to determine the feasibility and efficacy of an 8-week telehealth intervention of high intensity aerobic exercise prior to balance training compared to an 8-week telehealth intervention of low intensity exercise prior to balance training in people with spinocerebellar ataxias (SCAs). The investigators additionally aim to explore changes in motor skill learning on a novel motor skill task in a sub-group of participants pre and post intervention.
Read the detailed description
The PRIME-Ataxia randomized controlled trial involves 2 groups of participants (n=20). One group (high intensity exercise + balance) will receive high intensity aerobic exercise followed by balance training, and another group (low intensity exercise + balance) will receive low intensity exercise (stretching, warm up exercises) followed by balance training. Both groups will undergo four remote assessments (2 baseline assessments, a mid-intervention assessment, and a post-intervention assessment). A subset of individuals (n=12) from both groups will undergo an in-person assessment on a novel motor task, along with digital posturography assessment of standard functional assessments of mobility and balance at baseline 1 (week 0), and post-intervention (week 16).
- Conditions
- Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3, Spinocerebellar Ataxia Type 6, Spinocerebellar Ataxia Type 7
- Being tested
- High-Intensity Aerobic Exercise Prior to Balance Training, Low-Intensity Exercise Prior to Balance Training
- Keywords
- Aerobic Exercise, Balance, Motor Learning, Neurorehabilitation, Telehealth, Spinocerebellar Ataxia, Physical Therapy, Rehabilitation, Cerebellum, High intensity aerobic exercise
- Medical subject headings
- Spinocerebellar Ataxias, Machado-Joseph Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Aerobic Exercise Prior to Balance TrainingBehavioural
20-30 minutes of high intensity aerobic exercise followed by 20-30 minutes of individualized balance training over telehealth twice weekly, for 8 weeks (16 sessions total). For the aerobic component, participants will be instructed in a 20-30-minute exercise program, using available equipment already located in the participant's home (eg. stationary cycle, elliptical trainer, etc). Exercise intensity is moderate-to-high (between 50-85% Heart Rate Reserve. Participants will be placed on a ramped protocol which increases in intensity slowly over the course of the intervention period. For the balance training component, exercises will consist of steady state, proative, and reactive balance activities that involve sensory integration of vision, proprioception, and vestibular senses. Exercises will be individualized based on baseline assessment outcomes and severity of ataxia as rated by the SARAHome.
Low-Intensity Exercise Prior to Balance TrainingBehavioural
20-30 minutes of light intensity "warm-up" type exercises, followed by 20-30 minutes of individualized balance training over telehealth twice weekly, for 8 week (16 sessions total). For the "warm-up" exercise component, exercises will consist of stretching and core training. For the balance training component, exercises will consist of steady state, proactive, and reactive balance activities that involve sensory integration of vision, proprioception, and vestibular senses throughout. Exercises will be individualized based on baseline assessment outcomes and severity of ataxia as rated by the SARAHome.
Both groups are matched for time and frequency of intervention components.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | High-Intensity Aerobic Exercise Prior to Balance Training Receives: Behavioral: High-Intensity Aerobic Exercise Prior to Balance Training |
| Group 2 | Active comparator | Low-Intensity Exercise Prior to Balance Training Receives: Behavioral: Low-Intensity Exercise Prior to Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Scale for Assessment and Rating for Ataxia
Clinical rating scale for severity of ataxia symptoms. This is an 8-item clinical performance based scale, which individuals are graded according to total ataxia severity. Total scores can range from 0 (no ataxia) to 40 (most severe ataxia). Scores are based on performance of the following tasks: 1) Gait, 2) Stance, 3), Sitting, 4) Speech Disturbance, 5) Finger Chase, 6) Nose-Finger Test, 7) Fast alternating hand movements, 8) Heel-shin slide. For the purpose of this study, we will be performing a validated modified version of the SARA, referred to as the SARAHome. The SARAHome is comprised of the first four items and item 6 from the original SARA Scale (Gait, Stance, Walking, Speech, and Nose-Finger Test) and it will be administered via telehealth.
Measured: Baseline, Post-Intervention (4 months)
Change in Cerebellar Cognitive Affective Syndrome Scale
The Cerebellar Cognitive Affective Syndrome Scale (CCAS) was developed as a bedside quick screen for Cerebellar Cognitive Affective Symptom (also referred to as Schmalmann's Syndrome). The CCAS is a 10-item scale of cognitive and neuropsychiatric tests detailing executive function, working and verbal memory, language, visuospatial function, abstract reasoning, behavior and affect. Two scores are reported; a raw score ranging from 0 (severe cognitive impairment) to 120 points (no cognitive impairment), as well as a Pass/Fail marker for each of the 10 items on the scale. 1 fail is considered as possible cerebellar cognitive affective symptom, 2 fails are considered probable, and 3 fails are considered clinically definite.
Measured: Baseline, Post-Intervention (4 months)
Change in Patient Reported Outcome Measure for Ataxia
Patient reported outcome measure for people with ataxia. The test was developed to assess 3 domains (physical, activities of daily living, mental health) and 14 subdomains. It has been proven to be valid and reliable against measures of motor ataxia, mental health, and quality of life. The original Patient Reported Outcome Measure for Ataxia has 70 questions, and records a total score out of 280 possible points. For the purpose of this trial, we will use the Short-Form version of this assessment which asks 10 questions, and it scored out of a total of 40 possible points.
Measured: Baseline, Post-Intervention (4 months)
Secondary outcomes (7)
Activities Specific Balance Scale (ABC)
Patient reported outcome evaluating the balance confidence of a participant in performing a variety of activities without losing balance or experiencing a state of unsteadiness. Participants are asked to rank their perceived balance confidence on a scale of 0% (no balance confidence) to 100% (high balance confidence). All scores are summed, and averaged for a total overall estimate of balance confidence.
Measured: Baseline, Post-Intervention (4 months)
Digital Biomarker of Static Posturography
Participant will perform a series of static standing postures and postural sway will be recorded with a smart phone app, and/or inertial measurement units. Measure of postural sway will be recorded (higher values are worse outcomes).
Measured: Baseline, Post-Intervention (4 months)
Digital Biomarker of Dynamic Posturography
Participant will perform a walking test which will be recorded with a smart phone app, and/or inertial measurement units. Measure of postural sway will be recorded (higher values are worse outcomes).
Measured: Baseline, Post-Intervention (4 months)
Motor Adaptation
Prism Adaptation with finger targeting to touchscreen. Performed in a sub-set of participants for this trial.
Measured: Baseline, Post-Intervention (4 months)
Neurological Quality of Life
Self report of health related quality of life for people with neurological conditions. The measure that will be used in this trial is a short-form assessing social or functional roles and abilities. 8 questions with 5-item Likert response, higher score is better outcome.
Measured: Baseline, Post-Intervention (4 months)
Patient Global Impression of Change
Self-report measure that assesses a participants thoughts or beliefs about the efficacy of treatment. The Patient Global Impression of Change scale is a 7 point scale depicting a patient's rating of overall improvement, score 1-7, higher score is better.
Measured: Baseline, Post-Intervention (4 months)
Acceptability Questionnaire
Short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively.
Measured: Baseline, Post-Intervention (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start6 Feb 2023
- Primary completionDec 2024 (estimated)
- Study completion31 May 2025 (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 Spinocerebellar Ataxia Type 1Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teachers College, Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori Quinn, PT, EdD, Principal investigator, Teachers College, Columbia UniversityChelsea E Macpherson, DPT, Principal investigator, Teachers College, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826171
- Sponsor's protocol ID
- 23-088
- Acronym
- PRIME-Ataxia
- Status last verified
- May 2024
- First submitted
- 22 Mar 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macpherson CE, Awad F, Rana V, Kuo SH, Quinn L. Fatigue Limits Motor and Cognitive Improvements after High-intensity Exercise Prior to Balance Training over Telehealth in People with Spinocerebellar Ataxia. Int J Telerehabil. 2025 Dec 12;17(2):6713. doi: 10.63144/ijt.2025.6713. eCollection 2025.
PubMed 41445681
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia: a Randomized Controlled Trial (PRIME-Ataxia RCT)
- ClinicalTrials.gov ID
- NCT05826171
- Acronym / sponsor ID
- PRIME-Ataxia / 23-088
- Conditions
- Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3, Spinocerebellar Ataxia Type 6, Spinocerebellar Ataxia Type 7
- Keywords
- Aerobic Exercise, Balance, Motor Learning, Neurorehabilitation, Telehealth, Spinocerebellar Ataxia, Physical Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Teachers College, Columbia UniversityUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 24 Apr 2023 (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.
PRIME-Ataxia is a randomized controlled trial that aims to determine the feasibility and efficacy of an 8-week telehealth intervention of high intensity aerobic exercise prior to balance training compared to an 8-week telehealth intervention of low intensity exercise prior to balance training in people with spinocerebellar ataxias (SCAs). The investigators additionally aim to explore changes in motor skill learning on a novel motor skill task in a sub-group of participants pre and post intervention.
Detailed description
The PRIME-Ataxia randomized controlled trial involves 2 groups of participants (n=20). One group (high intensity exercise + balance) will receive high intensity aerobic exercise followed by balance training, and another group (low intensity exercise + balance) will receive low intensity exercise (stretching, warm up exercises) followed by balance training. Both groups will undergo four remote assessments (2 baseline assessments, a mid-intervention assessment, and a post-intervention assessment). A subset of individuals (n=12) from both groups will undergo an in-person assessment on a novel motor task, along with digital posturography assessment of standard functional assessments of mobility and balance at baseline 1 (week 0), and post-intervention (week 16).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: High-Intensity Aerobic Exercise Prior to Balance TrainingHigh-Intensity Aerobic Exercise Prior to Balance Training |
| Group 2 | Active comparator | Behavioral: Low-Intensity Exercise Prior to Balance TrainingLow-Intensity Exercise Prior to Balance Training |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between the ages of 18 to 85 years
- Genetically confirmed diagnosis of SCA1, 2, 3, 6, and 7
- Scale for Ataxia Rating and Assessment (SARA) score between 8-25/40, capturing mild-moderate disease
- Able to walk with/without assistive device
- Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) to confirm no medical contraindications to exercise
Key exclusion criteria (7 listed)
- Severe non-ataxic motor symptoms such as dystonia, tremor, or Parkinsonism, measured by Inventory of Non-Ataxia Signs (INAS)
- Peripheral sensory loss (as confirmed with monofilament or clinical proprioceptive testing)
- Severe visual complications associated with ataxia (i.e., Spontaneous nystagmus, retinal or optic nerve involvement, especially in SCA7) defined as as have a score on the Snellen Visual Acuity test = 20/200 - 20/400, OR a visual field of 20 degrees of less.
- Musculoskeletal injury that would prevent participation in an exercise program
- Other concurrent disease of the cerebellum (e.g. stroke, multiple sclerosis)
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 |
|---|---|---|
| High-Intensity Aerobic Exercise Prior to Balance Training20-30 minutes of high intensity aerobic exercise followed by 20-30 minutes of individualized balance training over telehealth twice weekly, for 8 weeks (16 sessions total). For the aerobic component, participants will be instructed in a 20-30-minute exercise program, using available equipment already located in the participant's home (eg. stationary cycle, elliptical trainer, etc). Exercise intensity is moderate-to-high (between 50-85% Heart Rate Reserve. Participants will be placed on a ramped protocol which increases in intensity slowly over the course of the intervention period. For the balance training component, exercises will consist of steady state, proative, and reactive balance activities that involve sensory integration of vision, proprioception, and vestibular senses. Exercises will be individualized based on baseline assessment outcomes and severity of ataxia as rated by the SARAHome. | Behavioural | Group 1 |
| Low-Intensity Exercise Prior to Balance Training20-30 minutes of light intensity "warm-up" type exercises, followed by 20-30 minutes of individualized balance training over telehealth twice weekly, for 8 week (16 sessions total). For the "warm-up" exercise component, exercises will consist of stretching and core training. For the balance training component, exercises will consist of steady state, proactive, and reactive balance activities that involve sensory integration of vision, proprioception, and vestibular senses throughout. Exercises will be individualized based on baseline assessment outcomes and severity of ataxia as rated by the SARAHome. Both groups are matched for time and frequency of intervention components. | Behavioural | Group 2 |
Primary outcome
Change in Scale for Assessment and Rating for Ataxia
Time frame: Baseline, Post-Intervention (4 months)
Clinical rating scale for severity of ataxia symptoms. This is an 8-item clinical performance based scale, which individuals are graded according to total ataxia severity. Total scores can range from 0 (no ataxia) to 40 (most severe ataxia). Scores are based on performance of the following tasks: 1) Gait, 2) Stance, 3), Sitting, 4) Speech Disturbance, 5) Finger Chase, 6) Nose-Finger Test, 7) Fast alternating hand movements, 8) Heel-shin slide. For the purpose of this study, we will be performing a validated modified version of the SARA, referred to as the SARAHome. The SARAHome is comprised of the first four items and item 6 from the original SARA Scale (Gait, Stance, Walking, Speech, and Nose-Finger Test) and it will be administered via telehealth.
Change in Cerebellar Cognitive Affective Syndrome Scale
Time frame: Baseline, Post-Intervention (4 months)
The Cerebellar Cognitive Affective Syndrome Scale (CCAS) was developed as a bedside quick screen for Cerebellar Cognitive Affective Symptom (also referred to as Schmalmann's Syndrome). The CCAS is a 10-item scale of cognitive and neuropsychiatric tests detailing executive function, working and verbal memory, language, visuospatial function, abstract reasoning, behavior and affect. Two scores are reported; a raw score ranging from 0 (severe cognitive impairment) to 120 points (no cognitive impairment), as well as a Pass/Fail marker for each of the 10 items on the scale. 1 fail is considered as possible cerebellar cognitive affective symptom, 2 fails are considered probable, and 3 fails are considered clinically definite.
Change in Patient Reported Outcome Measure for Ataxia
Time frame: Baseline, Post-Intervention (4 months)
Patient reported outcome measure for people with ataxia. The test was developed to assess 3 domains (physical, activities of daily living, mental health) and 14 subdomains. It has been proven to be valid and reliable against measures of motor ataxia, mental health, and quality of life. The original Patient Reported Outcome Measure for Ataxia has 70 questions, and records a total score out of 280 possible points. For the purpose of this trial, we will use the Short-Form version of this assessment which asks 10 questions, and it scored out of a total of 40 possible points.
7 secondary outcomes
Activities Specific Balance Scale (ABC)
Time frame: Baseline, Post-Intervention (4 months)
Digital Biomarker of Static Posturography
Time frame: Baseline, Post-Intervention (4 months)
Digital Biomarker of Dynamic Posturography
Time frame: Baseline, Post-Intervention (4 months)
Motor Adaptation
Time frame: Baseline, Post-Intervention (4 months)
Neurological Quality of Life
Time frame: Baseline, Post-Intervention (4 months)
Patient Global Impression of Change
Time frame: Baseline, Post-Intervention (4 months)
Acceptability Questionnaire
Time frame: Baseline, Post-Intervention (4 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 41445681Macpherson CE, Awad F, Rana V, Kuo SH, Quinn L. Fatigue Limits Motor and Cognitive Improvements after High-intensity Exercise Prior to Balance Training over Telehealth in People with Spinocerebellar Ataxia. Int J Telerehabil. 2025 Dec 12;17(2):6713. doi: 10.63144/ijt.2025.6713. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Lori Quinn, PT, EdD principal investigator
Teachers College, Columbia University
Chelsea E Macpherson, DPT principal investigator
Teachers College, Columbia 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 High-Intensity Aerobic Exercise Prior to Balance Training and Low-Intensity Exercise Prior to Balance Training in people with Spinocerebellar Ataxia Type 1 and Spinocerebellar Ataxia Type 2, run by Teachers College, Columbia University at 1 site in United States.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 May 2024. 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 United States. 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?
Results are not available in the source record.
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 Scale for Assessment and Rating for Ataxia (time frame: Baseline, Post-Intervention (4 months)). The study lists 3 primary outcomes in all. 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 NCT05826171, 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 3 May 2024.