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

NCT03883217 | Completed Results DMC FDA Device

• 1 other identifier: HM20015593
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Gait; Balance

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Throughout study completion, from 9 to 34 days.

Secondary Outcomes (4)

• Timed Up and Go (TUG) Test

  Throughout study completion, between 9 to 34 days.

• Berg Balance Scale (BBS)

  Throughout study completion, between 9 to 34 days.

• New Freezing of Gait Questionnaire (nFOG-Q)

  Throughout study completion, between 9 to 34 days.

• Fall Efficacy Scale - International

  Throughout study completion, between 9 to 34 days

Study Arms (2)

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.

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.

Device: Vibration Session; Device: No vibration session

Interventions

Vibration Session DEVICE

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.

Also known as: VibeForward (PDVibe2)

No vibration first then vibration; Vibration first then no vibration

No vibration session DEVICE

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.

Also known as: VibeForward (PDVibe2)

No vibration first then vibration; Vibration first then no vibration

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Ingrid Pretzer-Aboff
• Organization: Virginia Commonwealth University

iaboff@vcu.edu

302-893-9504

Study Officials

• Ingrid Pretzer-Aboff, PhD, RN

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Leslie Cloud, MD

  Virginia Commonwealth University Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: June 29, 2021
• Primary Completion: January 11, 2022
• Study Completion: January 11, 2022
• Last Updated: March 16, 2026
• Results First Posted: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)