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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My cervical dystonia diagnosis has been confirmed by a specialist.
Select...
I am between 30 and 85 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain effects measured with TMS
Brain effects measured with fMRI
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
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,631 Total Patients Enrolled
16 Trials studying Dystonia
557 Patients Enrolled for Dystonia
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,303 Total Patients Enrolled
59 Trials studying Dystonia
13,610 Patients Enrolled for Dystonia
Aparna Wagle Shukla, MDPrincipal InvestigatorUniversity of Florida
4 Previous Clinical Trials
52 Total Patients Enrolled
2 Trials studying Dystonia
45 Patients Enrolled for Dystonia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have major problems with your thinking and memory.My condition is considered moderate in severity.My condition is considered moderate in severity.I haven't seen much improvement despite taking the highest safe doses of BoNT injections for my neck and/or oral medications.I am currently in a structured exercise program or receiving therapy.You are not physically ready for the study based on a questionnaire about your activity level.I have severe pain, spine degeneration, or active joint inflammation.I have been diagnosed with focal cervical dystonia by a specialist.I have seizures and cannot undergo TMS or MRI due to claustrophobia.You have a pacemaker or other implanted electrical device that could be affected by MRI or TMS.My cervical dystonia diagnosis has been confirmed by a specialist.I do not have a pacemaker, neurostimulator, certain brain clips, or an active seizure disorder.You are able to handle physical activity sessions.I am between 30 and 85 years old.I haven't seen much improvement despite taking the highest safe doses of BoNT injections for my neck and/or oral medications.You can handle the exercise sessions.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care (non-exercise group).
- Group 2: Progressive resistance exercise (exercise group)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Dystonia Patient Testimony for trial: Trial Name: NCT05663840 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial include geriatric individuals among its participants?
"The current eligibility criteria for this study requires participants to be between 30-85 years old."
Answered by AI
Is enrolment still available for this research project?
"According to clinicaltrials.gov, this medical trial is not recruiting at present; the study was first publicised on January 1st 2023 and last updated December 15th 2022. Nonetheless, there are 31 other studies actively seeking participants now."
Answered by AI
Is participation in this experiment feasible for me?
"This clinical trial is enrolling 56 individuals aged 30-85 with dystonia. The diagnosis must be confirmed by a Movement Disorders Society specialist, and the patient's condition should not have responded to Botox injections or other oral medications. In addition, patients need to be able to tolerate exercise sessions and present moderate severity of disease symptoms."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I love to exercise and would like to see if this helps with my dystonia. To see if exercise can help since I used to exercise previously and this may help with symptoms.
PatientReceived 2+ prior treatments
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