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Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia (PRIME-Ataxia)

Primary Purpose

Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

High-Intensity Aerobic Exercise Prior to Balance Training

Low-Intensity Exercise Prior to Balance Training

About this trial

This is an interventional treatment trial for Spinocerebellar Ataxia Type 1 focused on measuring Aerobic Exercise, Balance, Motor Learning, Neurorehabilitation, Telehealth, Spinocerebellar Ataxia, Physical Therapy, Rehabilitation, Cerebellum, High intensity aerobic exercise

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

Teachers College, Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

High-Intensity Aerobic Exercise Prior to Balance Training

Low-Intensity Exercise Prior to Balance Training

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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).

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).

Motor Adaptation

Prism Adaptation with finger targeting to touchscreen. Performed in a sub-set of participants for this trial.

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.

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.

Acceptability Questionnaire

Short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively.

Full Information

NCT ID

NCT05826171

First Posted

March 22, 2023

Last Updated

October 12, 2023

Sponsor

Teachers College, Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT05826171

Brief Title

Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia

Acronym

PRIME-Ataxia

Official Title

Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia: a Randomized Controlled Trial (PRIME-Ataxia RCT)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 6, 2023 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teachers College, Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized Controlled Trial

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

High-Intensity Aerobic Exercise Prior to Balance Training

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

Low-Intensity Exercise Prior to Balance Training

Intervention Type

Behavioral

Intervention Name(s)

High-Intensity Aerobic Exercise Prior to Balance Training

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Low-Intensity Exercise Prior to Balance Training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Scale for Assessment and Rating for Ataxia

Description

Time Frame