Idiopathic Parkinson's DiseaseNCT02306863
Whole-body Vibration as a Treatment for Parkinson's Disease
A study testing vibrating chair in people with Idiopathic Parkinson's Disease and Primary Parkinsonism, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Parkinson's Disease, Primary Parkinsonism
- What is being tested?
- vibrating chair
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A neurological disease other than PD
- recent stroke
- cardiovascular disease
- previous major hemorrhage
- artificial pacemaker
- currently pregnant
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sun Life Financial Movement Disorders Research & Rehabilitation Centre
Waterloo, Ontario, N2L 3J5
Patricia Freeman, 519-884-0710 ext. 3924, pafreeman@wlu.ca
Adam Koebel, 519-884-0710, koeb2420@mylaurier.ca
About this study
Official title: The Efficacy of Long-term Whole-body Vibration in the Treatment of Parkinson's Disease
This study will evaluate whether whole-body vibration applied over a 12-week period is effective in treating motor symptoms of Parkinson's disease.
Read the 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.
- Being tested
- vibrating chair, sham treatment
- Keywords
- Parkinson's Disease, whole-body vibration, WBV
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibrating chairDevice
vibration provided via physioacoustic method
sham treatmentDevice
Also called placebo
simulated whole-body vibration
| Study group | Role | What they receive |
|---|---|---|
| whole-body vibration | Experimental | 40 Hz Whole-body vibration applied via physioaccoustic method for 12 weeks, 3 times a week Receives: Device: vibrating chair |
| sham treatment | Sham comparator | simulated whole-body vibration applied 3 times a week for 12 weeks Receives: Device: sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale (UPDRS) section III
clinician monitored motor evaluation
Measured: change from baseline, 12 weeks, and 2 week washout
Secondary outcomes (3)
Gait Assessment
pressure sensitive carpet (GAITRite) measuring gait parameters (step length, step velocity, stride-to-stride variability, etc)
Measured: change from baseline, 12 weeks, and 2 week washout
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
Measured: change from baseline, 12 weeks, and 2 week washout
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)
Measured: change from baseline, 12 weeks, and 2 week washout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Koebel, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
- Investigators
- Adam K Koebel, BSc, Principal investigator, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306863
- Sponsor's protocol ID
- 4291
- Status last verified
- Feb 2015
- First submitted
- 1 Dec 2014
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 16720935Ebersbach 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.
PubMed 18295614King 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.
PubMed 20037223
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Long-term Whole-body Vibration in the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02306863
- Acronym / sponsor ID
- 4291
- Keywords
- Parkinson's Disease, whole-body vibration, WBV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation CentreUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whole-body vibration | Experimental | Device: vibrating chair40 Hz Whole-body vibration applied via physioaccoustic method for 12 weeks, 3 times a week |
| sham treatment | Sham comparator | Device: sham treatmentsimulated whole-body vibration applied 3 times a week for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- A neurological disease other than PD
- recent stroke
- cardiovascular disease
- previous major hemorrhage
- artificial pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vibrating chairvibration provided via physioacoustic method | Device | whole-body vibration |
| sham treatmentAlso: placebosimulated whole-body vibration | Device | sham treatment |
Primary outcome
Unified Parkinson's Disease Rating Scale (UPDRS) section III
Time frame: change from baseline, 12 weeks, and 2 week washout
clinician monitored motor evaluation
3 secondary outcomes
Gait Assessment
Time frame: 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
Timed Grooved Pegboard Task
Time frame: change from baseline, 12 weeks, and 2 week washout
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Background: PubMed 16720935Haas 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.
- Background: PubMed 18295614Ebersbach 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.
- Background: PubMed 20037223King 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam K Koebel, BSc principal investigator
Wilfrid Laurier University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vibrating chair in people with Idiopathic Parkinson's Disease and Primary Parkinsonism, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam K Koebel, BSc (519-884-0710 ext. 3924, koeb2420@mylaurier.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's Disease Rating Scale (UPDRS) section III (time frame: change from baseline, 12 weeks, and 2 week washout). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02306863, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.