The purpose of this research study is to test the safety, tolerability, and the effect of vibration (delivered by an experimental device called PDVibe2) on freezing of gait (FOG) 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.
Enrolled patients with Parkinson's disease, Hoehn and Yahr Stage 2, will be randomized to receive either vibration or no vibration and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of two days followed by a washout period of 2 weeks. Each treatment period will consist of four treatments within 2 days, no more than 2 sessions in one day. Patients will participate in an additional day for screening and another for follow-up (6 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
12
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.
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. During this session, PDVibe2 delivers no vibration but is still worn. The internal circuitry has been miniaturized, is encased in a small box, and is attached to the ankle using a soft flexible band.
Virginia Commonwealth University
Richmond, Virginia, United States
Functional Ambulation Profile (FAP) Score
The Functional Ambulation Profile (FAP) score is the gold standard for spatiotemporal gait parameter analysis. For this study, it will be mean calculated by participants walking on the Zeno walkway, which will measure the patient's physical measurements, step length, step time and 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 walkway containing sensor pads. A full FAP (Functional Ambulation Profile) score is calculated by deducting points from a maximum score of 100 and the minimum is a 0, with points being subtracted based on deviations from normal gait patterns observed during a self-selected velocity walking trial; essentially, a higher score (closer to 100) indicates closer to normal gait function while a lower score (closer to 0) represents greater gait impairments. No subscales. This is reported as the mean of the two scores for each session aggregated.
Time frame: Throughout study completion, from 9 to 34 days.
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS),will be used to assess the total burden of motor Parkinson Disease (PD) symptoms and impact on activities of daily living. There are four sections to this scale and all sections use a scale of 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe)lower scores are better and indicate less disability. 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, Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). 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. This is reported as the mean of the scores for each session aggregated. The smaller the overall number (closer to 0), the less disability and the greater the number (closer to 148) the greater the disability.
Time frame: Throughout study completion, from 9 to 34 days.
Timed Up and Go (TUG) Test
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The Timed Up and Go (TUG) 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 times/measured in seconds is better. The Timed Up and Go (TUG) test is scored based on the time it takes to complete the test, in seconds: \< 10 seconds: Normal \< 20 seconds: Good mobility, can walk outside alone, no walking aid needed \< 30 seconds: Walking and balance problems, cannot walk outside alone, walking aid needed So less than 10 seconds would be normal and 30 seconds or more may indicate a higher risk of falling. This is reported as the mean of the scores for each session aggregated.
Time frame: Throughout study completion, between 9 to 34 days.
Berg Balance Scale (BBS)
The Berg Balance Scale (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 or total 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. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. So the closer to 0, the least function and the closer to 56, the more function a subject would have. This is reported as the mean of the scores for each session aggregated.
Time frame: Throughout study completion, between 9 to 34 days.
New Freezing of Gait Questionnaire (nFOG-Q)
The New Freezing of Gait Questionnaire (nFOG-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 (closer to 24) correspond to more severe and lower scores (closer to 0) have fewer symptoms on the New Freezing of Gait Questionnaire (nFOG-Q). To objectively assess FOG severity, Parkinson's disease (PD) subjects are asked to perform brief and standardized FOG-provoking tasks in clinical centers. Common tasks include timed-up-and-go (TUG), 180 or 360 degrees turning while walking and 360-degree turning-in-place (360Turn). This is reported as the mean of the scores for each session aggregated.
Time frame: Throughout study completion, between 9 to 34 days.
Fall Efficacy Scale - International
The Fall Efficacy Scale - International 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 concerned they are 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 closer to 64) the greater the fear of falling by the subject and the lower the score (closer to 16) the less fear of falling by the subject using the Fall Efficacy Scale - International. This is reported as the mean of the scores for each session aggregated.
Time frame: Throughout study completion, between 9 to 34 days