Parkinson DiseaseNCT03883217
Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
A study testing Vibration Session and No vibration session in people with Parkinson Disease, run by Virginia Commonwealth University at 1 site in United States.
Trial 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). 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?
- Vibration Session and No vibration session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 11 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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)
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the detailed description
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.
- Conditions
- Parkinson Disease
- Being tested
- Vibration Session, No vibration session
- 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.
Vibration SessionDevice
Also called VibeForward (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.
No vibration sessionDevice
Also called VibeForward (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. 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.
| Study group | Role | What they receive |
|---|---|---|
| Vibration first then no vibration | Experimental | A session with PDVibe2 vibration turned on first, followed by (after a 2 week washout period) a session with PDVibe2 vibration turned off. The two arms both get a session with the PDVibe2 vibration turned on and turned off, but the order is reversed depending on the arm. Receives: Device: Vibration Session; Device: No vibration session |
| No vibration first then vibration | Experimental | A session with PDVibe2 vibration turned off first, followed by (after a 2 week washout period) a session with PDVibe2 vibration turned on. The two arms both get a session with the PDVibe2 vibration turned on and turned off, but the order is reversed depending on the arm. Receives: Device: Vibration Session; Device: No vibration session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Throughout study completion, from 9 to 34 days.
Secondary outcomes (4)
Timed Up and Go (TUG) Test
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.
Measured: 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.
Measured: 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.
Measured: 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.
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 posted20 Mar 2019
- Study start29 Jun 2021
- Primary completion11 Jan 2022
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 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 Pretzer-Aboff, PhD, RN, Principal investigator, Virginia Commonwealth UniversityLeslie Cloud, MD, Principal investigator, Virginia Commonwealth University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883217
- Sponsor's protocol ID
- HM20015593
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2019
- Last updated
- 16 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 16 Mar 2026. 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
- ClinicalTrials.gov ID
- NCT03883217
- Acronym / sponsor ID
- HM20015593
- Conditions
- Parkinson Disease
- Keywords
- Gait, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Posted 16 Mar 2026
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 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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration first then no vibration | Experimental | Device: Vibration Session, Device: No vibration sessionA session with PDVibe2 vibration turned on first, followed by (after a 2 week washout period) a session with PDVibe2 vibration turned off. The two arms both get a session with the PDVibe2 vibration turned on and turned off, but the order is reversed depending on the arm. |
| No vibration first then vibration | Experimental | Device: Vibration Session, Device: No vibration sessionA session with PDVibe2 vibration turned off first, followed by (after a 2 week washout period) a session with PDVibe2 vibration turned on. The two arms both get a session with the PDVibe2 vibration turned on and turned off, but the order is reversed depending on the arm. |
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)
- 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 |
|---|---|---|
| Vibration SessionAlso: VibeForward (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. | Device | No vibration first then vibration, Vibration first then no vibration |
| No vibration sessionAlso: VibeForward (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. 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. | Device | No vibration first then vibration, Vibration first then no vibration |
Primary outcome
Functional Ambulation Profile (FAP) Score
Time frame: Throughout study completion, from 9 to 34 days.
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.
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
Time frame: Throughout study completion, from 9 to 34 days.
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.
4 secondary outcomes
Timed Up and Go (TUG) Test
Time frame: Throughout study completion, between 9 to 34 days.
Berg Balance Scale (BBS)
Time frame: Throughout study completion, between 9 to 34 days.
New Freezing of Gait Questionnaire (nFOG-Q)
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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Pretzer-Aboff, PhD, RN principal investigator
Virginia Commonwealth University
Leslie Cloud, MD principal investigator
Virginia Commonwealth University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration Session and No vibration session in people with Parkinson Disease, run by Virginia Commonwealth University at 1 site in United States.
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: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 16 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.). The study lists 2 primary outcomes in all. 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 16 Mar 2026.