Acute Effects of Whole Body Vibration for Individuals With Parkinson Disease
Impact of Whole Body Vibration on Backward Walking in Individuals With Parkinson's Disease: A Pilot Study
1 other identifier
interventional
26
1 country
1
Brief Summary
This is an exploratory study to assess the impact of whole body vibration on backward walking speed in people with Parkinson disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 3, 2024
CompletedFirst Posted
Study publicly available on registry
April 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedNovember 20, 2024
November 1, 2024
2 years
April 3, 2024
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-meter backward walk test (3MBWT)
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
Study Arms (2)
WBV Intervention
EXPERIMENTALParticipants 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.
Control group
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Mid-squats performed on level ground 5 repetitions of 60 seconds with 1 minute rest in between each set.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor Universitylead
- University of St. Augustine for Health Sciencescollaborator
Study Sites (1)
Baylor University
Waco, Texas, 76798, United States
Related Publications (7)
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.
PMID: 28511252BACKGROUNDHackney ME, Earhart GM. Backward walking in Parkinson's disease. Mov Disord. 2009 Jan 30;24(2):218-23. doi: 10.1002/mds.22330.
PMID: 18951535BACKGROUNDKwon 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.
PMID: 31591835BACKGROUNDFritz 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.
PMID: 23122938BACKGROUNDRogan 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.
PMID: 28800481BACKGROUNDArenales 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.
PMID: 36009865BACKGROUNDDincher 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.
PMID: 30689308BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Boddy
Baylor University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2024
First Posted
April 8, 2024
Study Start
September 1, 2022
Primary Completion
August 30, 2024
Study Completion
August 30, 2024
Last Updated
November 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share