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| ID | Type | Description | Link |
|---|---|---|---|
| 40115065 | Other Identifier | State of Florida | |
| OCR28822 | Other Identifier | UF Oncore |
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The purpose of this research study is to investigate how the brain and motor behavior changes in individuals with dystonia and other involuntary movement disorders and healthy individuals over time with exercise training.
The study team plan to conduct a randomized prospective, parallel-group, controlled study to examine the effects of exercises in dystonia and other involuntary movement disorders. Patients will be randomized to receive either progressive resistance training or a control treatment following the modified fitness protocol. The study team hypothesize that progressive resistance training will result in better outcomes compared to modified fitness protocol.
Data collect includes 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities (the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, COWA and Animals, and Brief Test of Attention); 4) tests assessing motor abilities including Toronto Western Spasmodic Rating Scale (TWSTRS) and Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS); 5) measures of anxiety and depression (Beck Depression Index, Hamilton Anxiety and Depression Rating Scales); 5) Cervical dystonia related quality of life (CDQ-24); 6) Visual Analog Scales-Quality of Life (VAS QOL) evaluating of health related quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progressive Resistance Training | Experimental | Participants assigned to this arm will receive progressive resistance training under the supervision of a personal trainer at a gym facility close to their home. They will be required to perform these exercises twice a week for the first six months. They will be monitored with an activity monitor. |
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| Control Arm | No Intervention | The control arm offered to subjects with dystonia and other involuntary muscle disorders, participants will be followed at baseline and 6 months similar to what will be done in active exercise arm but this arm will not receive exercise. They will be monitored with an activity monitor. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive Resistance Training | Behavioral | Participants will perform required resistance training exercises at regular intervals for a period of up to 3 years. They will be tested at a baseline visit, then every 6 months for a total of at least 5 visits. During these visits, they will be asked to complete the following: questionnaires about quality of life and depression, tests to measure strength and motor function, tests to measure cognition, an orientation session to learn a precision griping task, structural and functional MRI scans of the brain, measurement of brain waves using a non-invasive technique called electroencephalography (EEG) and muscle activity using electromyography (EMG), measurement of brain function with TMS, pregnancy test (if applicable). |
| Measure | Description | Time Frame |
|---|---|---|
| Toronto Western Spasmodic Torticollis Rating Scale Score | Investigate changes in clinical function before and after exercise intervention. A 35 point clinical tool for assessing and documenting the status of patients with spasmodic torticollis (cervical dystonia). | Baseline through 24 months |
| Burke-Fahn-Marsden Dystonia Rating Scale score | Investigate changes in clinical function before and after exercise intervention. This is a specific questionnaire for dystonia developed to assess the severity of the effect of dystonia on various parts of the body (eyes, mouth, speech/swallowing, neck, trunk, upper limb, and lower limb). Severity factors and provoking factors are rated on a scale from 0-4 and a total score is calculated. | Baseline through 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Investigate changes in motor cortex excitability via transcranial magnetic stimulation before and after exercise intervention | Baseline through 24 months |
| Oral Medication |
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Inclusion Criteria:
Patients with dystonia and other involuntary movement disorders will be recruited whose diagnosis will be confirmed by a Movement Disorders specialist following the criteria recommended by movement disorders society.
Exclusion Criteria:
Patients will be ineligible if they have a neurological history other than dystonia, have significant arthritis
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| Name | Affiliation | Role |
|---|---|---|
| Aparna Wagle Shukla, M.D. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
Individual participant data will be available without any personal identifiers included.
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| ID | Term |
|---|---|
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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Investigate changes in oral medications taken by participants before and after exercise intervention
| Baseline through 24 months |
| Changes in blood oxygen level-dependent (BOLD) signal | Investigate changes in motor cortex excitability via blood oxygen level-dependent (BOLD) signal before and after exercise intervention | Baseline through 24 months |
| Hand grip dynamometer | Investigate changes in maximum hand grip strength | Baseline through 24 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |