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Whole-body Vibration as a Treatment for Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02306863
Recruitment Status : Unknown
Verified February 2015 by Adam Koebel, Sun Life Financial Movement Disorders Research and Rehabilitation Centre.
Recruitment status was:  Recruiting
First Posted : December 3, 2014
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Adam Koebel, Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Primary Parkinsonism Device: vibrating chair Device: sham treatment Not Applicable

Detailed Description:

Parkinson's disease (PD) is a progressive neurodegenerative disease resulting in the loss of dopaminergic neurons projecting from the substantia nigra pars compacta to the striatum.

Whole-body vibration (WBV) is potentially beneficial in treating Parkinson's disease because it has been shown to elicit effects specific to both the brain and muscular system. Animal models of PD indicate that whole-body vibration can increase striatal dopamine levels, as well as the number of dopaminergic neurons in the substantia nigra. These findings were correlated with increased levels of brain-derived neurotrophic factor.

In addition to the potentially neuroplastic effects, >20 Hz WBV has been shown to improve muscular performance. Improved muscular performance is believed to be attributed to WBV induced neuromuscular effects rather than muscle hypertrophy, with the specific mechanism defined as the tonic vibration reflex.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Long-term Whole-body Vibration in the Treatment of Parkinson's Disease
Study Start Date : January 2015
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: whole-body vibration
40 Hz Whole-body vibration applied via physioaccoustic method for 12 weeks, 3 times a week
 Device: vibrating chair
vibration provided via physioacoustic method
Sham Comparator: sham treatment
simulated whole-body vibration applied 3 times a week for 12 weeks
 Device: sham treatment
simulated whole-body vibration
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale (UPDRS) section III [ Time Frame: change from baseline, 12 weeks, and 2 week washout ]
    clinician monitored motor evaluation


Secondary Outcome Measures :
  1. Gait Assessment [ Time Frame: change from baseline, 12 weeks, and 2 week washout ]
    pressure sensitive carpet (GAITRite) measuring gait parameters (step length, step velocity, stride-to-stride variability, etc)

  2. Timed Up & Go (TUG) Test [ Time Frame: change from baseline, 12 weeks, and 2 week washout ]
    measuring time participants take to stand up from chair, walk towards an obstacle, turn around, walk back to chair, and sit back down again

  3. Timed Grooved Pegboard Task [ Time Frame: change from baseline, 12 weeks, and 2 week washout ]
    25 pegs with a key along one side must be rotated to properly be inserted into slot on board (measuring time-in and time-out)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306863


Contacts
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Contact: Adam K Koebel, BSc 519-884-0710 ext 3924 koeb2420@mylaurier.ca
Contact: Patricia Freeman 519-884-0710 ext 2877 pafreeman@wlu.ca

Locations
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Canada, Ontario
Sun Life Financial Movement Disorders Research & Rehabilitation Centre Recruiting
Waterloo, Ontario, Canada, N2L 3J5
Contact: Patricia Freeman    519-884-0710 ext 3924    pafreeman@wlu.ca   
Contact: Adam Koebel    519-884-0710    koeb2420@mylaurier.ca   
Principal Investigator: Adam Koebel         
Sponsors and Collaborators
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Investigators
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Principal Investigator: Adam K Koebel, BSc Wilfrid Laurier University
More Information
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Publications:

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Responsible Party: Adam Koebel, Undergraduate Thesis Student, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
ClinicalTrials.gov Identifier: NCT02306863    
Other Study ID Numbers: 4291
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015
Keywords provided by Adam Koebel, Sun Life Financial Movement Disorders Research and Rehabilitation Centre:
Parkinson's Disease
whole-body vibration
WBV
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases