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Trial record 2 of 5 for:    Resonate 2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03883217
Recruitment Status : Not yet recruiting
First Posted : March 20, 2019
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE March 18, 2019
First Posted Date  ICMJE March 20, 2019
Last Update Posted Date February 19, 2020
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03883217 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • 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 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 [ 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 [ 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
Official Title  ICMJE Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Device: PDVibe2
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
Study Arms  ICMJE
  • Experimental: Vibration
    PDVibe2 with vibration turned on
    Intervention: Device: PDVibe2
  • No Intervention: No vibration
    PDVibe2 with vibration turned off
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gina Blackwell 804-921-9990 gina.blackwell@vcuhealth.org
Contact: Ingrid Pretzer-Aboff, PhD, RN 302-893-9504 iaboff@vcu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03883217
Other Study ID Numbers  ICMJE HM20015593
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Michael J. Fox Foundation for Parkinson's Research
Investigators  ICMJE
Principal Investigator: Ingrid Pretzer-Aboff, PhD, RN Virginia Commonwealth University
Principal Investigator: Leslie Cloud, MD Virginia Commonwealth University Health System
PRS Account Virginia Commonwealth University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP