DystoniaNCT05663840
Effects of Exercise on Dystonia Pathophysiology
A study testing Progressive resistance exercise in people with Dystonia, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to investigate how the brain and motor behavior changes in individuals with dystonia in response to exercise training. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Dystonia
- What is being tested?
- Progressive resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have predominantly focal cervical dystonia and whose diagnosis will be confirmed by a movement disorders specialist following criteria recommended by Movement Disorders Society.
- Moderate disease severity.
- Are 30 to 85 years old
- Are able to tolerate exercise sessions.
- Reporting suboptimal clinical benefits despite receiving maximally tolerated doses of BoNT injections for the neck muscles and/or oral pharmacological therapy.
Who cannot join
- Participating in an alternate structured exercise program, receiving regular physical or occupational therapy
- Have significant pain, spondylosis or active arthritis
- Fail the Physical Activity Readiness Questionnaire
- Have significant cognitive impairment
- Have implanted electrical device (eg, cardiac pacemaker or a DBS or a neurostimulator or metallic clip in their body, as necessitated by the risks of MRI or TMS
- Active seizure disorder; not be eligible for TMS and claustrophobic for MRI portion. 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.
- Pregnancy tests will be carried out for each female subject of child bearing potential prior to the participation in the study and prior to each follow up visit (as indicated).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32611
Aparna Wagle Shukla, MD, 352-273-5550, aparna.shukla@neurology.ufl.edu
Aparna Wagle Shukla, MD
About this study
Official title: Progressive Resistance Exercise and Dystonia Pathophysiology.
The purpose of this research study is to investigate how the brain and motor behavior changes in individuals with dystonia in response to exercise training.
Read the detailed description
Dystonia is a debilitating movement disorder. It involves involuntary muscle contractions with abnormal and repetitive movements, postures, or both. The current treatments for dystonia comprise of oral medications, botulinum toxin injections, and deep brain stimulation surgery. These treatments, despite optimal management, fail to improve symptoms in more than a third of patients and the improvements are often unpredictable. We will investigate the brain adaptation effects for progressive resistance exercise-focused cervical and shoulder training (PERFECT) in patients with focal cervical dystonia with functional MRI (fMRI) and transcranial magnetic stimulation (TMS) techniques for understanding the pathophysiology of dystonia and treatment related changes. The investigators propose to enroll patients with predominantly focal cervical dystonia and compare PERFECT plus standard-of-care (SOC) therapy (n = 27) with a control group of SOC therapy (n = 27). Participants in the PERFECT + SOC group will perform physical therapist-guided exercises twice a week for 6 months and participants in the SOC group will continue receiving standard pharmacological therapies at stable doses and they will not exercise.
- Conditions
- Dystonia
- Being tested
- Progressive resistance exercise, Standard of care
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance exerciseBehavioural
Patients with predominant symptoms of cervical dystonia will receive exercise training. Patients will receive progressive resistance exercise focused cervical and shoulder training (PERFECT) plus standard-of-care (SOC) therapy. Resistance training will consist of mainly muscle-strengthening exercises for the neck, shoulder and arms and a few upper trunk muscles. Resistance training will be guided by physical therapists at twice a week schedule for 6 months. These participants will also receive SOC therapy.
Standard of careBehavioural
Subjects will receive SOC therapy only
| Study group | Role | What they receive |
|---|---|---|
| Progressive resistance exercise (exercise group) | Experimental | Subjects will receive physical therapy that will predominantly include progressive resistance exercise training program along with continuation of standard of care (exercise group) Receives: Behavioral: Progressive resistance exercise |
| Standard of care (non-exercise group). | Active comparator | Subjects will receive continuation of standard of care (non-exercise group). Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain effects measured with fMRI
To measure change in BOLD (fMRI) signals to functional connectivity in active group vs the control group.
Measured: Baseline up to 6 months
Brain effects measured with TMS
To measure motor cortex excitability and plasticity in TMS findings.
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start13 Oct 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aparna Wagle Shukla, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663840
- Sponsor's protocol ID
- IRB202200490
- Other IDs
- 1R01NS122943
- Status last verified
- Jun 2025
- First submitted
- 5 Oct 2022
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Resistance Exercise and Dystonia Pathophysiology.
- ClinicalTrials.gov ID
- NCT05663840
- Acronym / sponsor ID
- IRB202200490
- Conditions
- Dystonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to investigate how the brain and motor behavior changes in individuals with dystonia in response to exercise training.
Detailed description
Dystonia is a debilitating movement disorder. It involves involuntary muscle contractions with abnormal and repetitive movements, postures, or both. The current treatments for dystonia comprise of oral medications, botulinum toxin injections, and deep brain stimulation surgery. These treatments, despite optimal management, fail to improve symptoms in more than a third of patients and the improvements are often unpredictable. We will investigate the brain adaptation effects for progressive resistance exercise-focused cervical and shoulder training (PERFECT) in patients with focal cervical dystonia with functional MRI (fMRI) and transcranial magnetic stimulation (TMS) techniques for understanding the pathophysiology of dystonia and treatment related changes. The investigators propose to enroll patients with predominantly focal cervical dystonia and compare PERFECT plus standard-of-care (SOC) therapy (n = 27) with a control group of SOC therapy (n = 27). Participants in the PERFECT + SOC group will perform physical therapist-guided exercises twice a week for 6 months and participants in the SOC group will continue receiving standard pharmacological therapies at stable doses and they will not exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive resistance exercise (exercise group) | Experimental | Behavioral: Progressive resistance exerciseSubjects will receive physical therapy that will predominantly include progressive resistance exercise training program along with continuation of standard of care (exercise group) |
| Standard of care (non-exercise group). | Active comparator | Behavioral: Standard of careSubjects will receive continuation of standard of care (non-exercise group). |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients have predominantly focal cervical dystonia and whose diagnosis will be confirmed by a movement disorders specialist following criteria recommended by Movement Disorders Society.
- Moderate disease severity.
- Are 30 to 85 years old
- Are able to tolerate exercise sessions.
- Reporting suboptimal clinical benefits despite receiving maximally tolerated doses of BoNT injections for the neck muscles and/or oral pharmacological therapy.
Key exclusion criteria (7 listed)
- Participating in an alternate structured exercise program, receiving regular physical or occupational therapy
- Have significant pain, spondylosis or active arthritis
- Fail the Physical Activity Readiness Questionnaire
- Have significant cognitive impairment
- Have implanted electrical device (eg, cardiac pacemaker or a DBS or a neurostimulator or metallic clip in their body, as necessitated by the risks of MRI or TMS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive resistance exercisePatients with predominant symptoms of cervical dystonia will receive exercise training. Patients will receive progressive resistance exercise focused cervical and shoulder training (PERFECT) plus standard-of-care (SOC) therapy. Resistance training will consist of mainly muscle-strengthening exercises for the neck, shoulder and arms and a few upper trunk muscles. Resistance training will be guided by physical therapists at twice a week schedule for 6 months. These participants will also receive SOC therapy. | Behavioural | Progressive resistance exercise (exercise group) |
| Standard of careSubjects will receive SOC therapy only | Behavioural | Standard of care (non-exercise group). |
Primary outcome
Brain effects measured with fMRI
Time frame: Baseline up to 6 months
To measure change in BOLD (fMRI) signals to functional connectivity in active group vs the control group.
Brain effects measured with TMS
Time frame: Baseline up to 6 months
To measure motor cortex excitability and plasticity in TMS findings.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
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Deep Brain Stimulation Surgery for Movement Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aparna Wagle Shukla, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance exercise in people with Dystonia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain effects measured with fMRI (time frame: Baseline up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.