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Physical Activity Coaching for Ataxia (EngageAtaxia Trial)

Phase 1

Waitlist Available

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 (total score of 40), capturing mild to moderate stage of the disease

Ambulatory for indoor and outdoor mobility without assistance or assistive device

Must not have

Other neurological disease or disorder such as stroke

Cardiac/pulmonary conditions that would affect participant's ability to participate in an exercise program

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-intervention (3 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a physical activity coaching program can help people with cerebellar ataxia increase their physical activity. The program will use a physical or occupational therapist to provide up to five one-on-one coaching sessions for newly diagnosed individuals. Participants will be assessed twice, three months apart, and will receive coaching interventions via Zoom healthcare platform.

Who is the study for?

This trial is for individuals with early-stage cerebellar ataxia who can walk indoors and outdoors without help or devices. They should have a SARA score of 8-25, indicating mild to moderate disease, and must be cleared medically to exercise.

What is being tested?

The study tests a physical activity coaching program delivered via Zoom by therapists. Participants will receive up to five one-on-one sessions aimed at increasing their physical activity as part of managing their condition.

What are the potential side effects?

Since the intervention involves exercise coaching, potential side effects may include muscle soreness or strain from increased physical activity. However, these are typically minor and manageable.

Eligibility Criteria

Inclusion Criteria

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

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

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I can walk indoors and outdoors without help or devices.

Select...

A neurologist has diagnosed me with cerebellar ataxia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a neurological condition like a stroke.

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My heart or lung condition doesn't limit my ability to exercise.

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I do not have any injuries that would stop me from exercising.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-intervention (3 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-intervention (3 months)

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Brunel Lifestyle Physical Activity Questionnaire

Change in Cerebellar Cognitive Affective Syndrome Scale

Change in Scale for Assessment and Rating for Ataxia

Secondary study objectives

Acceptability Questionnaire

Activities Specific Balance Scale (ABC)

Digital Biomarker of Dynamic Posturography

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Physical Activity CoachingExperimental Treatment1 Intervention

Participants will receive up to 5 individualized coaching sessions delivered via telehealth to facilitate and optimize exercise uptake. The therapist will facilitate discussion on specific and measurable goals, and will provide options for tracking their progress, such as written or web-based exercise logs or an activity monitor. The recommended exercises will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. Balance and strengthening exercises will also be recommended as appropriate.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical activity coaching

2014

N/A

~80

0 / 6Eligibility criteria met