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

NCT03872115 | Withdrawn DMC FDA Device

• 1 other identifier: HM20015593-P1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Keywords

Gait; Balance

Outcome Measures

Primary Outcomes (1)

• 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.

  Throughout study completion, from 9 to 34 days.

Secondary Outcomes (6)

• Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III

  Throughout study completion, between 9 to 34 days.

• Timed Up and Go Test

  Throughout study completion, between 9 to 34 days.

• Berg Balance Scale

  Throughout study completion, between 9 to 34 days.

• Freezing of Gait Questionnaire

  Throughout study completion, between 9 to 34 days

• Parkinson's Disease Questionnaire - 39

  Throughout study completion, between 9 to 34 days.

Study Arms (9)

Setting 1

EXPERIMENTAL

PDVibe2 set to high frequency and low amplitude

Device: PDVibe2

Setting 2

EXPERIMENTAL

PDVibe2 set to high frequency and medium amplitude

Device: PDVibe2

Setting 3

EXPERIMENTAL

PDVibe2 set to high frequency and high amplitude

Device: PDVibe2

Setting 4

EXPERIMENTAL

PDVibe2 set to medium frequency and low amplitude

Device: PDVibe2

Setting 5

EXPERIMENTAL

PDVibe2 set to medium frequency and medium amplitude

Device: PDVibe2

Setting 6

EXPERIMENTAL

PDVibe2 set to medium frequency and high amplitude

Device: PDVibe2

Setting 7

EXPERIMENTAL

PDVibe2 set to low frequency and low amplitude

Device: PDVibe2

Setting 8

EXPERIMENTAL

PDVibe2 set to low frequency and medium amplitude

Device: PDVibe2

Setting 9

EXPERIMENTAL

PDVibe2 set to low frequency and high amplitude

Device: PDVibe2

Interventions

PDVibe2 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

Setting 1; Setting 2; Setting 3; Setting 4; Setting 5; Setting 6; Setting 7; Setting 8; Setting 9

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) 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.

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

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

Study Officials

• Ingrid A Pretzer-Aboff, PhD, RN

  Virginia Commonweatlh University

  PRINCIPAL INVESTIGATOR

• Leslie Cloud, MD

  Virginia Commonweatlh University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcomes assessors will be blinded to the dose of vibration randomly assigned to participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 13, 2019
• Study Start: April 18, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share