Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease - Phase 1

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: PDVibe2


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: age 21 years or older PD diagnosed by a movement disorder specialist for 3 months or longer prior to recruitment PD medication regimen is stable over the last 3 months with no changes Hoehn & Yahr stage 2 (N = 13) and H&Y stage 3 (N=13), able to walk independently or with a simple assistive device (e.g., cane, walker) observed by the research team to have PD related gait disturbance such as FOG, shortened or irregular stride lengths, irregular step cadence, slowed speed while on their regular treatment regimen. Exclusion Criteria: diagnosed with a known Parkinson plus syndrome were previously exposed to vibration treatment for gait and balance presence of dementia (Montreal Cognitive Assessment < 21) additional disorders (not related to PD)impairing gait, stance, balance or coordination (e.g. stroke, leg amputations, or multiple sclerosis) history of implantable cardiac device or any other implanted electronic device except a deep brain stimulator (DBS) use of braces/orthotics that assist with walking are currently in physical therapy (PT) treatment for balance or gait peripheral neuropathy by exam any condition that, in the opinion of the PIs, would compromise participant safety, data integrity, or data interpretation. Children under the age of 18 Prisoners Women who are pregnant or may become pregnant during the course of this study since the safety of this device for an unborn child is unknown.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Setting 1<br>PDVibe2 set to high frequency and low amplitude | Device: PDVibe2<br>* 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.<br>* Other names: VibeForward;|
| Experimental: Setting 2<br>PDVibe2 set to high frequency and medium amplitude | Device: PDVibe2<br>* 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.<br>* Other names: VibeForward;|
| Experimental: Setting 3<br>PDVibe2 set to high frequency and high amplitude | Device: PDVibe2<br>* 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.<br>* Other names: VibeForward;|
| Experimental: Setting 4<br>PDVibe2 set to medium frequency and low amplitude | Device: PDVibe2<br>* 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.<br>* Other names: VibeForward;|
| Experimental: Setting 5<br>PDVibe2 set to medium frequency and medium amplitude | Device: PDVibe2<br>* 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.<br>* Other names: VibeForward;|
| Experimental: Setting 6<br>PDVibe2 set to medium frequency and high amplitude | Device: PDVibe2<br>* 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.<br>* Other names: VibeForward;|
| Experimental: Setting 7<br>PDVibe2 set to low frequency and low amplitude | Device: PDVibe2<br>* 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.<br>* Other names: VibeForward;|
| Experimental: Setting 8<br>PDVibe2 set to low frequency and medium amplitude | Device: PDVibe2<br>* 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.<br>* Other names: VibeForward;|
| Experimental: Setting 9<br>PDVibe2 set to low frequency and high amplitude | Device: PDVibe2<br>* 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.<br>* Other names: VibeForward;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait, Balance