Acute Effects of Whole Body Vibration for Individuals With Parkinson Disease

NCT ID: NCT06352905

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-08-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Whole body vibration (WBV)

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Mid-squats performed on level ground 5 repetitions of 60 seconds with 1 minute rest in between each set.

Interventions

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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.

Intervention Type OTHER

Control

Mid-squats performed on level ground 5 repetitions of 60 seconds with 1 minute rest in between each set.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of St. Augustine for Health Sciences

OTHER

Sponsor Role collaborator

Baylor University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Boddy

Role: PRINCIPAL_INVESTIGATOR

Baylor University

Locations

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Baylor University

Waco, Texas, United States

Site Status

Countries

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United States

References

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Tarakad A, Jankovic J. Diagnosis and Management of Parkinson's Disease. Semin Neurol. 2017 Apr;37(2):118-126. doi: 10.1055/s-0037-1601888. Epub 2017 May 16.

Reference Type BACKGROUND
PMID: 28511252 (View on PubMed)

Hackney ME, Earhart GM. Backward walking in Parkinson's disease. Mov Disord. 2009 Jan 30;24(2):218-23. doi: 10.1002/mds.22330.

Reference Type BACKGROUND
PMID: 18951535 (View on PubMed)

Kwon KY, Park S, Lee HM, Park YM, Kim J, Kim J, Koh SB. Backward Gait is Associated with Motor Symptoms and Fear of Falling in Patients with De Novo Parkinson's Disease. J Clin Neurol. 2019 Oct;15(4):473-479. doi: 10.3988/jcn.2019.15.4.473.

Reference Type BACKGROUND
PMID: 31591835 (View on PubMed)

Fritz NE, Worstell AM, Kloos AD, Siles AB, White SE, Kegelmeyer DA. Backward walking measures are sensitive to age-related changes in mobility and balance. Gait Posture. 2013 Apr;37(4):593-7. doi: 10.1016/j.gaitpost.2012.09.022. Epub 2012 Nov 2.

Reference Type BACKGROUND
PMID: 23122938 (View on PubMed)

Rogan S, Taeymans J, Radlinger L, Naepflin S, Ruppen S, Bruelhart Y, Hilfiker R. Effects of whole-body vibration on postural control in elderly: An update of a systematic review and meta-analysis. Arch Gerontol Geriatr. 2017 Nov;73:95-112. doi: 10.1016/j.archger.2017.07.022. Epub 2017 Aug 3.

Reference Type BACKGROUND
PMID: 28800481 (View on PubMed)

Arenales Arauz YL, Ahuja G, Kamsma YPT, Kortholt A, van der Zee EA, van Heuvelen MJG. Potential of Whole-Body Vibration in Parkinson's Disease: A Systematic Review and Meta-Analysis of Human and Animal Studies. Biology (Basel). 2022 Aug 19;11(8):1238. doi: 10.3390/biology11081238.

Reference Type BACKGROUND
PMID: 36009865 (View on PubMed)

Dincher A, Schwarz M, Wydra G. Analysis of the Effects of Whole-Body Vibration in Parkinson Disease - Systematic Review and Meta-Analysis. PM R. 2019 Jun;11(6):640-653. doi: 10.1002/pmrj.12094. Epub 2019 May 6.

Reference Type BACKGROUND
PMID: 30689308 (View on PubMed)

Other Identifiers

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2157711

Identifier Type: -

Identifier Source: org_study_id

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