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

Idiopathic Parkinson's Disease Clinical Trial

Official title:

The Efficacy of Long-term Whole-body Vibration in the Treatment of Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02306863
• Other study ID #: 4291
• 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

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease
• Parkinsonian Disorders
• Primary Parkinsonism

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