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Device feasibility study, not clinical trial
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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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The purpose of this research study is to determine optimum dose of vibration delivered by an experimental device called PDVibe2 required to treat freezing of gait in persons with Parkinson's disease (PD). The PDVibe2 was developed by Resonate Forward, LLC (RF). This PDVibe2 was designed to administer vibration therapy to the wearer to improve gait and balance in persons with PD while wearing the device.
Participation will require up to 8 treatment sessions within 5 days (no more than 2 sessions in one day) plus an additional day for screening and another for follow-up (7 days total). All visits will occur at the Virginia Commonwealth University Parkinson's Movement and Disorders Center in Richmond, VA. Participants will be asked to walk for a brief period of time while wearing the PDVibe2. The PDVibe2 will provide vibration therapy and study staff will measure the number of "freezes" before, during and after therapy. Participants will be asked to provide feedback on the device, the therapy session and how they are feeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Setting 1 | Experimental | PDVibe2 set to high frequency and low amplitude |
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| Setting 2 | Experimental | PDVibe2 set to high frequency and medium amplitude |
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| Setting 3 | Experimental | PDVibe2 set to high frequency and high amplitude |
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| Setting 4 | Experimental | PDVibe2 set to medium frequency and low amplitude |
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| Setting 5 | Experimental | PDVibe2 set to medium frequency and medium amplitude |
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| Setting 6 | Experimental | PDVibe2 set to medium frequency and high amplitude |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDVibe2 | Device | The PDVibe2 is owned by Resonate Forward, LLC and will be loaned to Virginia Commonwealth University (VCU) for this project. The device is non-invasive, lightweight, untethered, contains a rechargeable battery, and is worn on both feet and ankles. PDVibe2 delivers vibration when activated by an easy to access switch on the device or by remote. The internal circuitry has been miniaturized, is encased in a small box, and is attached to the ankle using a soft flexible band. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Ambulation Profile (FAP) Score | The FAP score is the gold standard for spatiotemporal gait parameter analysis. For this study, it will be calculated by participants walking on the Zeno walkway, which will measure the patient's physical measurements, step length, step time and degree of symmetry.Step length, step time, degree of symmetry, dynamic base of support and the use of ambulatory aids are factored into the score. The Zeno instrumented walkway (PKMAS) is a 20-foot computerized instrumented walkway containing sensor pads. | Throughout study completion, from 9 to 34 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III | The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS), parts II-IV will be used to assess the total burden of motor Parkinson Disease (PD) symptoms and impact on activities of daily living. All parts use scale of 0 (no problem) - 4 (severe problems) lower scores are better. Part II: 13 items about Activities of Daily Living, score range 0-52. Part III: 18 items PD motor signs, score range is 0-72, Part IV: 6 items, assesses dyskinesia (excessive motion) and motor fluctuations (medication is working or not), range is 0-24. Parts II-IV total scores will be summed and used to describe the participants, total score range 0-148. Part III, only, will be repeated during vibration and post vibration data collection times and will take 5 minutes to complete. This outcome measure will be used to report a change in PD motor symptoms from baseline, to vibration on, and at follow up two after treatment is completed. |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingrid A Pretzer-Aboff, PhD, RN | Virginia Commonweatlh University | Principal Investigator |
| Leslie Cloud, MD | Virginia Commonweatlh University Health System | Principal Investigator |
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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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Investigators and outcomes assessors will be blinded to the dose of vibration randomly assigned to participants.
| Setting 7 | Experimental | PDVibe2 set to low frequency and low amplitude |
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| Setting 8 | Experimental | PDVibe2 set to low frequency and medium amplitude |
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| Setting 9 | Experimental | PDVibe2 set to low frequency and high amplitude |
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| Throughout study completion, between 9 to 34 days. |
| Timed Up and Go Test | This test is a one item performance test. The participant starts by sitting in a chair, then stand up, walk 3 meters, turn around, walk back, and sit down. Participants are timed in seconds. TUG is used to identify/screen elderly individuals who are prone to falls. Lower numbers are better. | Throughout study completion, between 9 to 34 days. |
| Berg Balance Scale | The BBS assesses balance via performing 14 functional activities. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score is a summation of all items and ranges from 0 to 56. Higher scores indicate less risk of falls. A cutoff score of 45 has been traditionally identified as a useful cutoff to predict falls in those who scored below the cutoff score. | Throughout study completion, between 9 to 34 days. |
| Freezing of Gait Questionnaire | The FOG-Q is a six-item questionnaire that uses a 5-point scale that ranges from 0 = absence of symptoms to 4 = most severe stage. The total score ranges from 0 to 24; higher scores correspond to more severe FOG. | Throughout study completion, between 9 to 34 days |
| Parkinson's Disease Questionnaire - 39 | This is a 39 item self-report questionnaire assesses how often patients experience difficulties across the 8 quality of life dimensions of functioning and well-being. A five-point ordinal scoring system ranges from 0 Never to 5 = Always or cannot do at all. Scores are calculated for each dimension (sum of items divided by number of items /100; total score is summative | Throughout study completion, between 9 to 34 days. |
| Fall Efficacy Scale - International | This survey includes 16 items assessing fear of falling in different scenarios, in a community dwelling older population. Individuals are instructed to rate each activity on a four-point Likert scale, depending on how they concerned that they may fall when performing certain activities. Items are scored from 1 = Not at all concerned to 4 = very concerned. The total score ranges from 16 - 64. The higher the score the greater the fear of falling. | Throughout study completion, between 9 to 34 days. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |