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Exercise Intensity and Balance Training for Spinocerebellar Ataxia (PRIME-Ataxia Trial)

N/A

Waitlist Available

Led By Lori Quinn, PT, EdD

Research Sponsored by Teachers College, Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scale for Ataxia Rating and Assessment (SARA) score between 8-25/40, capturing mild-moderate disease

Able to walk with/without assistive device

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-intervention (4 months)

Awards & highlights

PRIME-Ataxia Trial Summary

This trial will explore the effects of exercise intensity on balance training for people with SCAs, and explore motor skill learning pre and post intervention in a sub-group.

Who is the study for?

This trial is for people aged 18-85 with a confirmed genetic diagnosis of Spinocerebellar Ataxia types SCA1, 2, 3, 6, or 7. Participants should have mild to moderate disease severity and be able to walk with or without help. They need a care partner available during sessions and must not have been doing intense exercise recently.Check my eligibility

What is being tested?

The PRIME-Ataxia study tests if high-intensity aerobic exercise before balance training is more effective than low-intensity exercise for the same purpose in individuals with SCAs. This telehealth program runs for eight weeks and includes an assessment of motor skill learning.See study design

What are the potential side effects?

While specific side effects are not listed, typical risks may include muscle soreness, fatigue from high-intensity workouts, increased risk of falls due to balance issues especially post-exercise when fatigued.

PRIME-Ataxia Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My ataxia is mild to moderate, with a SARA score between 8-25.

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I can walk, with or without help from a device.

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My condition is genetically confirmed as SCA1, 2, 3, 6, or 7.

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I am between 18 and 85 years old.

PRIME-Ataxia Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (4 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intervention (4 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (4 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cerebellar Cognitive Affective Syndrome Scale

Change in Patient Reported Outcome Measure for Ataxia

Change in Scale for Assessment and Rating for Ataxia

Secondary outcome measures

Acceptability Questionnaire

Activities Specific Balance Scale (ABC)

Digital Biomarker of Dynamic Posturography

+4 more

PRIME-Ataxia Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1Experimental Treatment1 Intervention

High-Intensity Aerobic Exercise Prior to Balance Training

Group II: Group 2Active Control1 Intervention

Low-Intensity Exercise Prior to Balance Training

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Teachers College, Columbia UniversityLead Sponsor

24 Previous Clinical Trials

5,837 Total Patients Enrolled

Lori Quinn, PT, EdDPrincipal InvestigatorTeachers College, Columbia University

Chelsea E Macpherson, DPTPrincipal InvestigatorTeachers College, Columbia University

Media Library

High-Intensity Aerobic Exercise Prior to Balance Training Clinical Trial Eligibility Overview. Trial Name: NCT05826171 — N/A

Spinocerebellar Ataxias Research Study Groups: Group 1, Group 2

Spinocerebellar Ataxias Clinical Trial 2023: High-Intensity Aerobic Exercise Prior to Balance Training Highlights & Side Effects. Trial Name: NCT05826171 — N/A

High-Intensity Aerobic Exercise Prior to Balance Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05826171 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment open to seniors above the age of eighty?

"To be included in the trial, individuals must fall between 18 and 85 years old. Separately, 15 trials are available for underage patients while 32 studies target those above 65."

Answered by AI

Is admission still available for those wishing to join this research project?

"Affirmative. Clinicaltrials.gov data demonstrates that this research program, which was initially posted on February 6th 2023, is actively searching for subjects to participate in the trial. A total of twenty individuals are required from a single medical centre."

Answered by AI

What criteria is necessary to become a participant in this clinical experiment?

"To meet the eligibility requirements of this clinical trial, individuals must be diagnosed with spinocerebellar ataxias and between the ages of 18-85. Currently, approximately 20 participants are being recruited for participation."

Answered by AI

How many individuals are currently taking part in this medical experiment?

"Affirmative. As per the information posted on clinicialtrials.gov, this research project is currently seeking participants and was initially listed on February 6th 2023 with an update made at April 21st 2023. A total of twenty individuals are sought from a single medical site."

Answered by AI

What is the main aim of this experiment?

"This study intends to evaluate the efficacy of a novel intervention across Baseline and Post-Intervention (4 months) via assessing Change in Cerebellar Cognitive Affective Syndrome Scale. Secondary metrics include Digital Biomarker of Static Posturography, which consists of measuring postural sway with either a smartphone app or inertial measurement units; Dynamic Posturography, in which participants must traverse a walking test while being monitored by mobile application or IMU's; as well as Motor Adaptation, where select individuals will be tasked with finger-targeting touchscreen during Prism Adaptation tests."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia

2023. "Priming Motor Learning Through Exercise in People With Spinocerebellar Ataxia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05826171.

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