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| ID | Type | Description | Link |
|---|---|---|---|
| MJFF-024692 | Other Grant/Funding Number | Michael J. Fox Foundation for Parkinson's Research |
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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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The goals of this clinical trial are to 1) learn how two different rehabilitation interventions for PD can reduce Freezing of Gait (FOG) in people with Parkinson's disease, as assessed by patients, clinicians, and wearable sensors, and 2) to explore whether two different rehabilitation intervention can reduce FOG and improve daily life mobility in people with FOG sufficiently to justify a clinical trial.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic balance exercise intervention group | Experimental | Six weeks of exercise intervention to improve gait disturbances. Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding. |
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| Strength training exercise intervention group | Active Comparator | Six weeks of exercise intervention to improve gait disturbances. Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental intervention | Behavioral | Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient- Perceived Freezing of Gait Severity | Change in freezing of gait severity with the intervention (scored in likert scale by the patient; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse) | From enrollment/randomization through intervention; 8 weeks |
| Clinician- Perceived Freezing of Gait Severity | Change in freezing of gait severity with the intervention (scored in likert scale by the clinician; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse | From enrollment/randomization through intervention; 8 weeks |
| Sensors-based Freezing of gait severity | Freezing of Gait Index calculated during a 360 degrees turning in place from wearable sensors; continuous scale, with a higher positive score meaning a greater level of freezing of gait. | From enrollment/randomization through intervention; 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent in FOG during daily life | % time spent FOG compared to walking during daily life calculated from wearable sensors | From enrollment/randomization through intervention; 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Graham R Harker, MPH | Contact | (503) 418-2601 | harkerg@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Martina Mancini, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Recruiting | Tempe | Arizona | 85281 | United States | |
| Oregon Health and Science University |
De-identified data related to study outcomes measures will be publicly shared
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Data would be available 6 months after publication.
Data will be deposited on Zenodo https://zenodo.org/records/12548174
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Active intervention | Behavioral | Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding. |
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| Recruiting |
| Portland |
| Oregon |
| 97239 |
| United States |
| University of São Paulo, Bauru Campus | Recruiting | Bauru | São Paulo | 17012-230 | Brazil |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |