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Vibration Impact on Parkinson's Tremor

NCT ID: NCT03799614

Last Updated: 2020-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2019-11-27

Brief Summary

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The primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called RMBand that is worn on the subject's arm) on parkinsonian tremor. The RMBand was developed by Resonate Forward, LLC (RF). This RMBand is designed to administer a vibration to the wearer to decrease or stop tremor in persons with Parkinson's disease (PD).

Detailed Description

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Participation will be completed in one visit at VCU Parkinson's and Movement Disorders Center. A baseline Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) will be taken prior to vibration therapy. The RMBand (experimental device) will be placed on the arm of the participant to provide the vibration therapy. The MDS-UPDRS Part III will be repeated both during and after the therapy. Participants will be asked to provide feedback about the device, the therapy session and how they are feeling.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lower dose vibration

RMBand lower dose vibration

Group Type EXPERIMENTAL

RMBand lower dose

Intervention Type DEVICE

Light-weight portable device that delivers low dose vibration to the arm

Higher dose vibration

RMBand higher dose vibration

Group Type EXPERIMENTAL

RMBand higher dose

Intervention Type DEVICE

Light-weight portable device that delivers higher dose vibration to the arm

Interventions

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RMBand lower dose

Light-weight portable device that delivers low dose vibration to the arm

Intervention Type DEVICE

RMBand higher dose

Light-weight portable device that delivers higher dose vibration to the arm

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Parkinson's disease (PD) as diagnosed by a movement disorder specialist
* Tremor caused by their Parkinson's disease
* Ability to provide informed consent

Exclusion Criteria

* Known diagnosis of Parkinson Plus Syndrome
* Dementia
* Other known non-PD cause of tremor
* Other known non-PD cause of limb dysfunction
* Presence of implantable cardiac device, severe neuropathy or sensory loss that would prevent perception of vibration stimulus
* Non-English speaker
* Prisoners
* Pregnant women
Minimum Eligible Age

21 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ingrid Pretzer-Aboff, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HM20012404

Identifier Type: -

Identifier Source: org_study_id