Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT03883217|
Recruitment Status : Not yet recruiting
First Posted : March 20, 2019
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: PDVibe2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
PDVibe2 with vibration turned on
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.
Other Name: VibeForward
No Intervention: No vibration
PDVibe2 with vibration turned off
- Functional Ambulation Profile (FAP) Score [ Time Frame: Throughout study completion, from 9 to 34 days. ]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.
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III [ Time Frame: Throughout study completion, between 9 to 34 days. ]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.
- Timed Up and Go (TUG) Test [ Time Frame: Throughout study completion, between 9 to 34 days. ]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.
- Berg Balance Scale (BBS) [ Time Frame: Throughout study completion, between 9 to 34 days. ]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.
- Freezing of Gait Questionnaire (FOG-Q) [ Time Frame: Throughout study completion, between 9 to 34 days ]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.
- Parkinson's Disease Questionnaire - 39 [ Time Frame: Throughout study completion, between 9 to 34 days. ]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
- Fall Efficacy Scale - International [ Time Frame: Throughout study completion, between 9 to 34 days. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883217
|Contact: Gina Blackwellemail@example.com|
|Contact: Ingrid Pretzer-Aboff, PhD, RNfirstname.lastname@example.org|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Ingrid Pretzer-Aboff, PhD, RN||Virginia Commonwealth University|
|Principal Investigator:||Leslie Cloud, MD||Virginia Commonwealth University Health System|