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

Primary Purpose

Parkinson Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PDVibe2
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Gait, Balance

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Setting 1

Setting 2

Setting 3

Setting 4

Setting 5

Setting 6

Setting 7

Setting 8

Setting 9

Arm Description

PDVibe2 set to high frequency and low amplitude

PDVibe2 set to high frequency and medium amplitude

PDVibe2 set to high frequency and high amplitude

PDVibe2 set to medium frequency and low amplitude

PDVibe2 set to medium frequency and medium amplitude

PDVibe2 set to medium frequency and high amplitude

PDVibe2 set to low frequency and low amplitude

PDVibe2 set to low frequency and medium amplitude

PDVibe2 set to low frequency and high amplitude

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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
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.

Full Information

First Posted
March 6, 2019
Last Updated
March 11, 2019
Sponsor
Virginia Commonwealth University
Collaborators
Michael J. Fox Foundation for Parkinson's Research
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1. Study Identification

Unique Protocol Identification Number
NCT03872115
Brief Title
Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
Official Title
Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease - Phase 1
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Device feasibility study, not clinical trial
Study Start Date
April 18, 2019 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Michael J. Fox Foundation for Parkinson's Research

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Gait, Balance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Investigators and outcomes assessors will be blinded to the dose of vibration randomly assigned to participants.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Setting 1
Arm Type
Experimental
Arm Description
PDVibe2 set to high frequency and low amplitude
Arm Title
Setting 2
Arm Type
Experimental
Arm Description
PDVibe2 set to high frequency and medium amplitude
Arm Title
Setting 3
Arm Type
Experimental
Arm Description
PDVibe2 set to high frequency and high amplitude
Arm Title
Setting 4
Arm Type
Experimental
Arm Description
PDVibe2 set to medium frequency and low amplitude
Arm Title
Setting 5
Arm Type
Experimental
Arm Description
PDVibe2 set to medium frequency and medium amplitude
Arm Title
Setting 6
Arm Type
Experimental
Arm Description
PDVibe2 set to medium frequency and high amplitude
Arm Title
Setting 7
Arm Type
Experimental
Arm Description
PDVibe2 set to low frequency and low amplitude
Arm Title
Setting 8
Arm Type
Experimental
Arm Description
PDVibe2 set to low frequency and medium amplitude
Arm Title
Setting 9
Arm Type
Experimental
Arm Description
PDVibe2 set to low frequency and high amplitude
Intervention Type
Device
Intervention Name(s)
PDVibe2
Other Intervention Name(s)
VibeForward
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Ambulation Profile (FAP) Score
Description
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.
Time Frame
Throughout study completion, from 9 to 34 days.
Secondary Outcome Measure Information:
Title
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III
Description
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.
Time Frame
Throughout study completion, between 9 to 34 days.
Title
Timed Up and Go Test
Description
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.
Time Frame
Throughout study completion, between 9 to 34 days.
Title
Berg Balance Scale
Description
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.
Time Frame
Throughout study completion, between 9 to 34 days.
Title
Freezing of Gait Questionnaire
Description
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.
Time Frame
Throughout study completion, between 9 to 34 days
Title
Parkinson's Disease Questionnaire - 39
Description
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
Time Frame
Throughout study completion, between 9 to 34 days.
Title
Fall Efficacy Scale - International
Description
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.
Time Frame
Throughout study completion, between 9 to 34 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid A Pretzer-Aboff, PhD, RN
Organizational Affiliation
Virginia Commonweatlh University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leslie Cloud, MD
Organizational Affiliation
Virginia Commonweatlh University Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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