NCT06352905

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

April 3, 2024

Last Update Submit

November 18, 2024

Conditions

Keywords

Parkinson diseasebackward walkingwhole body vibration

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

EXPERIMENTAL

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)

Control group

ACTIVE COMPARATOR

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

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.

WBV Intervention
ControlOTHER

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

Control group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Baylor University

Waco, Texas, 76798, United States

Location

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: 28511252BACKGROUND
  • Hackney ME, Earhart GM. Backward walking in Parkinson's disease. Mov Disord. 2009 Jan 30;24(2):218-23. doi: 10.1002/mds.22330.

    PMID: 18951535BACKGROUND
  • 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.

    PMID: 31591835BACKGROUND
  • 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.

    PMID: 23122938BACKGROUND
  • 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.

    PMID: 28800481BACKGROUND
  • 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.

    PMID: 36009865BACKGROUND
  • 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.

    PMID: 30689308BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Anne Boddy

    Baylor University

    PRINCIPAL INVESTIGATOR

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

Locations