- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02306863
Whole-body Vibration as a Treatment for Parkinson's Disease
The Efficacy of Long-term Whole-body Vibration in the Treatment of Parkinson's Disease
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Waterloo, Ontario, Canada, N2L 3J5
- Recruiting
- Sun Life Financial Movement Disorders Research & Rehabilitation Centre
-
Contact:
- Patricia Freeman
- Phone Number: 3924 519-884-0710
- Email: pafreeman@wlu.ca
-
Contact:
- Adam Koebel
- Phone Number: 519-884-0710
- Email: koeb2420@mylaurier.ca
-
Principal Investigator:
- Adam Koebel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: whole-body vibration
40 Hz Whole-body vibration applied via physioaccoustic method for 12 weeks, 3 times a week
|
vibration provided via physioacoustic method
|
|
Sham Comparator: sham treatment
simulated whole-body vibration applied 3 times a week for 12 weeks
|
simulated whole-body vibration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) section III
Time Frame: change from baseline, 12 weeks, and 2 week washout
|
clinician monitored motor evaluation
|
change from baseline, 12 weeks, and 2 week washout
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
change from baseline, 12 weeks, and 2 week washout
|
|
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
|
change from baseline, 12 weeks, and 2 week washout
|
|
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)
|
change from baseline, 12 weeks, and 2 week washout
|
Collaborators and Investigators
Investigators
- Principal Investigator: Adam K Koebel, BSc, Wilfrid Laurier University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4291
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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