Parkinson DiseaseNCT03872115
Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
A study testing PDVibe2 in people with Parkinson Disease, run by Virginia Commonwealth University.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- PDVibe2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2019to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
About this study
Official title: Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease - Phase 1
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- PDVibe2
- Keywords
- Gait, Balance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDVibe2Device
Also called VibeForward
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.
| Study group | Role | What they receive |
|---|---|---|
| Setting 1 | Experimental | PDVibe2 set to high frequency and low amplitude Receives: Device: PDVibe2 |
| Setting 2 | Experimental | PDVibe2 set to high frequency and medium amplitude Receives: Device: PDVibe2 |
| Setting 3 | Experimental | PDVibe2 set to high frequency and high amplitude Receives: Device: PDVibe2 |
| Setting 4 | Experimental | PDVibe2 set to medium frequency and low amplitude Receives: Device: PDVibe2 |
| Setting 5 | Experimental | PDVibe2 set to medium frequency and medium amplitude Receives: Device: PDVibe2 |
| Setting 6 | Experimental | PDVibe2 set to medium frequency and high amplitude Receives: Device: PDVibe2 |
| Setting 7 | Experimental | PDVibe2 set to low frequency and low amplitude Receives: Device: PDVibe2 |
| Setting 8 | Experimental | PDVibe2 set to low frequency and medium amplitude Receives: Device: PDVibe2 |
| Setting 9 | Experimental | PDVibe2 set to low frequency and high amplitude Receives: Device: PDVibe2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout study completion, from 9 to 34 days.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Throughout study completion, between 9 to 34 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start18 Apr 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: Device feasibility study, not clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Ingrid A Pretzer-Aboff, PhD, RN, Principal investigator, Virginia Commonweatlh UniversityLeslie Cloud, MD, Principal investigator, Virginia Commonweatlh University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872115
- Sponsor's protocol ID
- HM20015593-P1
- Status last verified
- Oct 2024
- First submitted
- 6 Mar 2019
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease - Phase 1
- ClinicalTrials.gov ID
- NCT03872115
- Acronym / sponsor ID
- HM20015593-P1
- Conditions
- Parkinson Disease
- Keywords
- Gait, Balance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Device feasibility study, not clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 18 Apr 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Setting 1 | Experimental | Device: PDVibe2PDVibe2 set to high frequency and low amplitude |
| Setting 2 | Experimental | Device: PDVibe2PDVibe2 set to high frequency and medium amplitude |
| Setting 3 | Experimental | Device: PDVibe2PDVibe2 set to high frequency and high amplitude |
| Setting 4 | Experimental | Device: PDVibe2PDVibe2 set to medium frequency and low amplitude |
| Setting 5 | Experimental | Device: PDVibe2PDVibe2 set to medium frequency and medium amplitude |
| Setting 6 | Experimental | Device: PDVibe2PDVibe2 set to medium frequency and high amplitude |
| Setting 7 | Experimental | Device: PDVibe2PDVibe2 set to low frequency and low amplitude |
| Setting 8 | Experimental | Device: PDVibe2PDVibe2 set to low frequency and medium amplitude |
| Setting 9 | Experimental | Device: PDVibe2PDVibe2 set to low frequency and high amplitude |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDVibe2Also: VibeForwardThe 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. | Device | Setting 1, Setting 2, Setting 3, Setting 4, Setting 5, Setting 6, Setting 7, Setting 8, Setting 9 |
Primary outcome
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.
6 secondary outcomes
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III
Time frame: Throughout study completion, between 9 to 34 days.
Timed Up and Go Test
Time frame: Throughout study completion, between 9 to 34 days.
Berg Balance Scale
Time frame: Throughout study completion, between 9 to 34 days.
Freezing of Gait Questionnaire
Time frame: Throughout study completion, between 9 to 34 days
Parkinson's Disease Questionnaire - 39
Time frame: Throughout study completion, between 9 to 34 days.
Fall Efficacy Scale - International
Time frame: Throughout study completion, between 9 to 34 days.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid A Pretzer-Aboff, PhD, RN principal investigator
Virginia Commonweatlh University
Leslie Cloud, MD principal investigator
Virginia Commonweatlh University Health System
Questions about this trial
What is this clinical trial studying?
A study testing PDVibe2 in people with Parkinson Disease, run by Virginia Commonwealth University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Ambulation Profile (FAP) Score (time frame: Throughout study completion, from 9 to 34 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.