Whole-body Vibration as a Treatment for Parkinson's Disease
Primary Purpose
Idiopathic Parkinson's Disease, Primary Parkinsonism
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
vibrating chair
sham treatment
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's Disease, whole-body vibration, WBV
Eligibility 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)
Sites / Locations
- Sun Life Financial Movement Disorders Research & Rehabilitation CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
whole-body vibration
sham treatment
Arm Description
40 Hz Whole-body vibration applied via physioaccoustic method for 12 weeks, 3 times a week
simulated whole-body vibration applied 3 times a week for 12 weeks
Outcomes
Primary Outcome Measures
Unified Parkinson's Disease Rating Scale (UPDRS) section III
clinician monitored motor evaluation
Secondary Outcome Measures
Gait Assessment
pressure sensitive carpet (GAITRite) measuring gait parameters (step length, step velocity, stride-to-stride variability, etc)
Timed Up & Go (TUG) Test
measuring time participants take to stand up from chair, walk towards an obstacle, turn around, walk back to chair, and sit back down again
Timed Grooved Pegboard Task
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)
Full Information
NCT ID
NCT02306863
First Posted
December 1, 2014
Last Updated
February 13, 2015
Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
1. Study Identification
Unique Protocol Identification Number
NCT02306863
Brief Title
Whole-body Vibration as a Treatment for Parkinson's Disease
Official Title
The Efficacy of Long-term Whole-body Vibration in the Treatment of Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Life Financial Movement Disorders Research and Rehabilitation Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease, Primary Parkinsonism
Keywords
Parkinson's Disease, whole-body vibration, WBV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
whole-body vibration
Arm Type
Experimental
Arm Description
40 Hz Whole-body vibration applied via physioaccoustic method for 12 weeks, 3 times a week
Arm Title
sham treatment
Arm Type
Sham Comparator
Arm Description
simulated whole-body vibration applied 3 times a week for 12 weeks
Intervention Type
Device
Intervention Name(s)
vibrating chair
Intervention Description
vibration provided via physioacoustic method
Intervention Type
Device
Intervention Name(s)
sham treatment
Other Intervention Name(s)
placebo
Intervention Description
simulated whole-body vibration
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) section III
Description
clinician monitored motor evaluation
Time Frame
change from baseline, 12 weeks, and 2 week washout
Secondary Outcome Measure Information:
Title
Gait Assessment
Description
pressure sensitive carpet (GAITRite) measuring gait parameters (step length, step velocity, stride-to-stride variability, etc)
Time Frame
change from baseline, 12 weeks, and 2 week washout
Title
Timed Up & Go (TUG) Test
Description
measuring time participants take to stand up from chair, walk towards an obstacle, turn around, walk back to chair, and sit back down again
Time Frame
change from baseline, 12 weeks, and 2 week washout
Title
Timed Grooved Pegboard Task
Description
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)
Time Frame
change from baseline, 12 weeks, and 2 week washout
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam K Koebel, BSc
Phone
519-884-0710
Ext
3924
Email
koeb2420@mylaurier.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Freeman
Phone
519-884-0710
Ext
2877
Email
pafreeman@wlu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam K Koebel, BSc
Organizational Affiliation
Wilfrid Laurier University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Life Financial Movement Disorders Research & Rehabilitation Centre
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3J5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Freeman
Phone
519-884-0710
Ext
3924
Email
pafreeman@wlu.ca
First Name & Middle Initial & Last Name & Degree
Adam Koebel
Phone
519-884-0710
Email
koeb2420@mylaurier.ca
First Name & Middle Initial & Last Name & Degree
Adam Koebel
12. IPD Sharing Statement
Citations:
PubMed Identifier
16720935
Citation
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.
Results Reference
background
PubMed Identifier
18295614
Citation
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.
Results Reference
background
PubMed Identifier
20037223
Citation
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.
Results Reference
background
Learn more about this trial
Whole-body Vibration as a Treatment for Parkinson's Disease
We'll reach out to this number within 24 hrs