NCT02306863

Brief Summary

This study will evaluate whether whole-body vibration applied over a 12-week period is effective in treating motor symptoms of Parkinson's disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

December 1, 2014

Last Update Submit

February 13, 2015

Conditions

Idiopathic Parkinson's DiseasePrimary Parkinsonism

Keywords

Parkinson's Diseasewhole-body vibrationWBV

Outcome Measures

Primary Outcomes (1)

  • Unified Parkinson's Disease Rating Scale (UPDRS) section III

    clinician monitored motor evaluation

    change from baseline, 12 weeks, and 2 week washout

Secondary Outcomes (3)

  • Gait Assessment

    change from baseline, 12 weeks, and 2 week washout

  • Timed Up & Go (TUG) Test

    change from baseline, 12 weeks, and 2 week washout

  • Timed Grooved Pegboard Task

    change from baseline, 12 weeks, and 2 week washout

Study Arms (2)

whole-body vibration

EXPERIMENTAL

40 Hz Whole-body vibration applied via physioaccoustic method for 12 weeks, 3 times a week

Device: vibrating chair

sham treatment

SHAM COMPARATOR

simulated whole-body vibration applied 3 times a week for 12 weeks

Device: sham treatment

Interventions

vibrating chairDEVICE

vibration provided via physioacoustic method

whole-body vibration
sham treatmentDEVICE

simulated whole-body vibration

Also known as: placebo
sham treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with idiopathic Parkinson's Disease by a Neurologist
  • Currently taking anti-Parkinsonian medication
  • Able to stand for 2 minutes without assistance
  • Able to walk 10 meters without assistance
  • Ability to understand English instructions
  • Normal or corrected vision

You may not qualify if:

  • A neurological disease other than PD
  • recent stroke
  • cardiovascular disease
  • previous major hemorrhage
  • artificial pacemaker
  • currently pregnant
  • Current participation in any physical therapy or experimental treatments
  • Peripheral neuropathy, severe osteoporosis
  • Visual impairments that cannot be corrected
  • Clinically diagnosed with dementia
  • Greater than mild dementia (screened using Montreal Cognitive Assessment (MOCA) \<24 being excluded)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Life Financial Movement Disorders Research & Rehabilitation Centre

Waterloo, Ontario, N2L 3J5, Canada

RECRUITING

Related Publications (3)

  • Haas CT, Turbanski S, Kessler K, Schmidtbleicher D. The effects of random whole-body-vibration on motor symptoms in Parkinson's disease. NeuroRehabilitation. 2006;21(1):29-36.

    PMID: 16720935BACKGROUND

  • Ebersbach G, Edler D, Kaufhold O, Wissel J. Whole body vibration versus conventional physiotherapy to improve balance and gait in Parkinson's disease. Arch Phys Med Rehabil. 2008 Mar;89(3):399-403. doi: 10.1016/j.apmr.2007.09.031.

    PMID: 18295614BACKGROUND

  • King LK, Almeida QJ, Ahonen H. Short-term effects of vibration therapy on motor impairments in Parkinson's disease. NeuroRehabilitation. 2009;25(4):297-306. doi: 10.3233/NRE-2009-0528.

    PMID: 20037223BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Adam K Koebel, BSc

    Wilfrid Laurier University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam K Koebel, BSc

CONTACT

519-884-0710koeb2420@mylaurier.ca

Patricia Freeman

CONTACT

519-884-0710pafreeman@wlu.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Undergraduate Thesis Student

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations

CA(1)