Acute Effects of Whole Body Vibration for Individuals With Parkinson Disease

April 3, 2024 updated by: Baylor University

Impact of Whole Body Vibration on Backward Walking in Individuals With Parkinson's Disease: A Pilot Study

This is an exploratory study to assess the impact of whole body vibration on backward walking speed in people with Parkinson disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will provide valuable information towards the relationship between backward walking using the 3-minute backward walk test and whole body vibration (WBV). The 3MBWT has shown to have diagnostic accuracy for fall prediction in older adults. The 3MBWT has been found to be feasible within the acute stroke population. In a study, the 3MBWT revealed that in the geriatric population a score of more than 4.5 seconds were likely to report a fall history. Gait parameters including a decrease in gait velocity (p<0.01) have been found to worsen while performing dual tasks (serial-7 subtraction) in individuals with PD. Research has shown when compared to other cognitive tests, the "serial sevens" tests increased the time required to perform the Timed Up and Go in individuals with PD.

This study will use a control group performing mid-squats on level ground and an intervention group performing mid-squats on a WBV machine. Each group will perform 5 sets of mid-squats for 60 seconds with a 60 second rest period between each set. Pre and post testing will involve three trials of the 3MBWT.

The purpose of this study is to determine the immediate impact of WBV on backward walking velocity in individuals diagnosed with PD.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Assistant Vice Provost for Research
  • Phone Number: 254-710-3708
  • Email: IRB@baylor.edu

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosed with Parkinson disease (PD)
  • classified Hoehn and Yahr stages I - IV
  • ability to walk independently for at least 5 minutes
  • alert and oriented to person, place and time
  • Age between 40-85 years old

Exclusion Criteria:

  • Deep-Brain Stimulation surgery less than 24 months prior to the start of the study
  • physician changes in Deep-Brain Stimulation parameters during the study
  • acute orthopedic injury or surgery that could impact gait
  • a neurological condition other than PD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WBV Intervention
Participants will complete testing on the 3 meter backward test (3MBWT) for 3 trials (pretest). Participants will perform mid-squats on a whole body vibration (WBV) platform. The participant will complete the WBV with the platform next to a wall so they can use the wall for balance if needed. Additionally, supervision or hand held assist will be provided if needed for balance by a licensed physical therapist. After the completion of the WBV session, the participant will complete testing 3MBWT for 3 trials (posttest). All participants will have a gait belt donned the entire time and be closely guarded during every test by a licensed physical therapist. At any point the participant appears unsafe to continue, the protocol will stop immediately. Participants will be given the option to stop and rest when needed.
Other: Whole body vibration (WBV)
WBV is a platform that vibrates while a person stands or sits and performs exercises. The WBV session will consist of 5 sets of 60 seconds set at 6 Hertz (frequency), 3 mm (amplitude) while performing mid-squats. There will be a 1 minute rest in between each set. These parameters were chosen as commonly used parameters in previous studies of WBV in people with PD.
Active Comparator: Control group
Participants will complete testing on the 3 meter backward test (3MBWT) for 3 trials (pretest). Participants will perform 5 sets of 60 seconds of mid-squats on level ground. There will be a 1 minute rest in between each set. The participant will complete the mid-squats next to a wall so they can use the wall for balance if needed. Additionally, supervision or hand held assist will be provided if needed for balance by a licensed physical therapist. After the completion of the the mid-squats, the participant will complete testing 3MBWT for 3 trials (posttest). All participants will have a gait belt donned the entire time and be closely guarded during every test by a licensed physical therapist. At any point the participant appears unsafe to continue, the protocol will stop immediately. Participants will be given the option to stop and rest when needed.
Other: Control
Mid-squats performed on level ground 5 repetitions of 60 seconds with 1 minute rest in between each set.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-meter backward walk test (3MBWT)
Time Frame: 5 minutes
The 3MBWT has excellent intrarater reliability as a backward walking velocity assessment. This standardized measure demonstrates diagnostic accuracy for predicting falls within a year in healthy older adults and people with Parkinson disease. Participants stand with their heel touching a line of tape on the floor and are instructed to initiate backward walking at the verbal cue "start" and to continue until instructed to stop (3 meters) by the tester guarding. The average of 3 trials is the score.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor University

Collaborators

University of St. Augustine for Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2157711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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