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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02306863
Other study ID # 4291
Secondary ID
Status Recruiting
Phase N/A
First received December 1, 2014
Last updated February 13, 2015
Start date January 2015
Est. completion date August 2015

Study information

Verified date February 2015
Source Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Contact Adam K Koebel, BSc
Phone 519-884-0710
Email koeb2420@mylaurier.ca
Is FDA regulated No
Health authority Canada: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Device:
vibrating chair
vibration provided via physioacoustic method
sham treatment
simulated whole-body vibration

Locations

Country Name City State
Canada Sun Life Financial Movement Disorders Research & Rehabilitation Centre Waterloo Ontario

Sponsors (1)

Lead Sponsor Collaborator
Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Unified Parkinson's Disease Rating Scale (UPDRS) section III clinician monitored motor evaluation change from baseline, 12 weeks, and 2 week washout No
Secondary Gait Assessment 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 No
Secondary 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 change from baseline, 12 weeks, and 2 week washout No
Secondary 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) change from baseline, 12 weeks, and 2 week washout No
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