Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia

NCT05826171 | Active Not Recruiting

• 1 other identifier: 23-088
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

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; Cerebellum; High intensity aerobic exercise

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, Post-Intervention (4 months)

Secondary Outcomes (7)

• Activities Specific Balance Scale (ABC)

  Baseline, Post-Intervention (4 months)

• Digital Biomarker of Static Posturography

  Baseline, Post-Intervention (4 months)

• Digital Biomarker of Dynamic Posturography

  Baseline, Post-Intervention (4 months)

• Motor Adaptation

  Baseline, Post-Intervention (4 months)

• Neurological Quality of Life

  Baseline, Post-Intervention (4 months)

Study Arms (2)

Group 1

EXPERIMENTAL

High-Intensity Aerobic Exercise Prior to Balance Training

Behavioral: High-Intensity Aerobic Exercise Prior to Balance Training

Group 2

ACTIVE COMPARATOR

Low-Intensity Exercise Prior to Balance Training

Behavioral: Low-Intensity Exercise Prior to Balance Training

Interventions

High-Intensity Aerobic Exercise Prior to Balance Training BEHAVIORAL

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.

Group 1

Low-Intensity Exercise Prior to Balance Training BEHAVIORAL

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.

Group 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teachers College, Columbia University: lead

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

Related Publications (1)

• 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.

  PMID: 41445681 DERIVED

MeSH Terms

Conditions

Spinocerebellar Ataxias; Machado-Joseph Disease

Condition Hierarchy (Ancestors)

Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lori Quinn, PT, EdD

  Teachers College, Columbia University

  PRINCIPAL INVESTIGATOR

• Chelsea E Macpherson, DPT

  Teachers College, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 24, 2023
• Study Start: February 6, 2023
• Primary Completion: December 1, 2024
• Study Completion: May 31, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)