Acute Effects of Whole Body Vibration for Individuals With Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06352905
• Other study ID #: 2157711
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Baylor University
• Contact: Assistant Vice Provost for Research
• Phone: 254-710-3708
• Email: IRB[@]baylor.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United States	Baylor University	Waco	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor University	University of St. Augustine for Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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