Clinical trial NCT06352905: Acute Effects of Whole Body Vibration for Individuals With Parkinson Disease
Official title: Impact of Whole Body Vibration on Backward Walking in Individuals With Parkinson's Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
backward walking
whole body vibration
Lead sponsor: Baylor University
Sponsor class: OTHER
Collaborators: name: University of St. Augustine for Health Sciences
First posted: 2024-04-08
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: 3-meter backward walk test (3MBWT)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
affiliation: Baylor University
name: Anne Boddy
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.
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.