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Exercise for Dystonia

N/A

Recruiting

Led By Aparna Wagle Shukla, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

Patients have predominantly focal cervical dystonia and whose diagnosis will be confirmed by a movement disorders specialist following criteria recommended by Movement Disorders Society

Are 30 to 85 years old

Must not have

Have significant pain, spondylosis or active arthritis

As necessitated by the risks of MRI or TMS, patients who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator), or a certain type of metallic clip in their body (i.e., an aneurysm clip in the brain), active seizure disorder are not eligible for participation in the MRI or TMS portion of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how exercise affects the brain and movement in people with dystonia.

Who is the study for?

This trial is for individuals aged 30-85 with moderate cervical dystonia, confirmed by a specialist. They should be able to exercise but not currently in another structured program or receiving regular therapy. Participants must not have significant pain, arthritis, cognitive impairments, implanted electrical devices, active seizures, and women of childbearing age must pass pregnancy tests.

What is being tested?

The study is examining the effects of progressive resistance exercise compared to standard care on brain and motor behavior changes in people with dystonia. It aims to see if exercise can improve symptoms for those who haven't fully benefited from injections or oral medications.

What are the potential side effects?

While specific side effects are not listed for this type of non-drug intervention trial, general risks may include muscle soreness or injury from exercising. Standard care typically has minimal side effects.

Eligibility Criteria

Inclusion Criteria

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

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My cervical dystonia diagnosis has been confirmed by a specialist.

Select...

I am between 30 and 85 years old.

Exclusion Criteria

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

Select...

I have severe pain, spine degeneration, or active joint inflammation.

Select...

I do not have a pacemaker, neurostimulator, certain brain clips, or an active seizure disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 6 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

Brain effects measured with TMS

Brain effects measured with fMRI

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Progressive resistance exercise (exercise group)Experimental Treatment1 Intervention

Subjects will receive physical therapy that will predominantly include progressive resistance exercise training program along with continuation of standard of care (exercise group)

Group II: Standard of care (non-exercise group).Active Control1 Intervention

Subjects will receive continuation of standard of care (non-exercise group).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Progressive resistance exercise

2022

N/A

~50

0 / 4Eligibility criteria met