- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03777501
The Effect of Whole Body Vibration in Individuals With Parkinson's Disease
January 22, 2020 updated by: Kuan-yi Li, Chang Gung University
The Effect of Whole Body Vibration on Sensorimotor Function in Individuals With Parkinson's Disease
Previous studies reported that whole body vibration has the potential impact on balance and walking abilities in individuals with Parkinson's disease; however, the inconsistent treatment protocols and different experimental designs lead to inconclusive results.
Therefore, the purpose of this study is to investigate the short term and long term effect of whole body vibration on sensorimotor function in individuals with Parkinson's disease.
The experimental design will be randomized double-blinded controlled trial.
Sixty individuals with idiopathic Parkinson's disease will be randomly assigned to two groups and they are non-random whole body vibration group and conventional therapy group.
Each participant will receive the treatment about one hour after the administration of medicine.
For non-random whole body vibration group, participants will be required to maintain the erect standing position on the vibratory platform and the frequency and amplitude of vibratory stimuli will be 6Hz and 3mm respectively.
Each treatment includes five sessions and each session is composed of one minute whole body vibration and one minute rest.
For the conventional therapy group, participants will receive the occupational therapy including dynamic balance training and functional ambulatory training.
Each session is 10 minutes in both groups and all participants will receive one and twelve treatment sessions for short-term and long-term effect respectively.
Outcome measures include proprioceptive sensitivity threshold of upper limb, position sense test of the knee joint, Unified Parkinson's disease rating scale-motor (UPDRS motor), functional reach, and time up and go test (TUG).
Specifically, the investigators want to answer the following four questions: 1) Is there any difference in proprioceptive sensitivity, motor performance and balance before and after treatment in individuals with Parkinson's disease?
2) Is there any difference in short-term and long term effect of whole body vibration in individuals with Parkinson's disease? 3) Is there any difference in treatment effect in individuals with Parkinson's disease in Taiwan?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Linkou, Taiwan, 333
- Chang Gung Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- agree to sign the informed consent form.
- diagnosed with idiopathic Parkinson's disease with Hoehn and Yahr stage 2~3
- cognitive impairment (Mini-Mental State Examination [MMSE] score greater than 24 points
- no depression as evaluated by the Beck Depression Inventory
- no severe arm injuries or shoulder dislocation which might interfere with proprioceptive function
- can perform reaching movement
- no diagnosed peripheral nerve disorders or other neurologic conditions
- no severe tremor which might interfere with the measurement proprioceptive function
Exclusion Criteria:
- diagnosed with other central nervous system diseases, ex: stroke
- had surgeries in head or arms
- unable to sit for assessment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: non-random whole body vibration group
Each participant will receive the non-random type whole body vibration treatment about one hour after the administration of medicine.
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Each participant will receive the treatment about one hour after the administration of medicine.
For non-random whole body vibration group, participants will be required to maintain the erect standing position on the vibratory platform and the frequency and amplitude of vibratory stimuli will be 6Hz and 3mm respectively.
Each treatment includes five sessions and each session is composed of one minute whole body vibration and one minute rest.
|
ACTIVE_COMPARATOR: conventional therapy group
For the conventional therapy group, participants will receive the occupational therapy including dynamic balance training and functional ambulatory training.
Each session is 10 minutes.
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Participants will receive the occupational therapy including dynamic balance training and functional ambulatory training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in just noticeable difference threshold of proprioceptive sensitivity
Time Frame: baseline, 1 day and 4 weeks
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This experiment will use psychophysical methods to assess subject perception, the psychophysical methods developed two thresholds: detection threshold/absolute threshold and difference threshold/just noticeable difference threshold (JNDT).
Difference threshold represents the minimum difference between two different intensity stimulation.
In this experiment, the investigator will test the difference threshold for position sense and passive motion sense
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baseline, 1 day and 4 weeks
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Change of position sense of the knee joint
Time Frame: baseline, 1 day and 4 weeks
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In the beginning, each subject sits comfortably in an arm chair (knee flexion 90o).
The subject's non-affected leg is passively moved at three target angles (knee flexion 15, 30 and 70 degrees), and maintained the testing angle for 15 seconds before being return to knee flexion 90 degree (initial position).
Subjects will be required to move the knee joint of the ipsilateral leg to the target angle.
The assessor will use a hand-held goniometer to measure the angle of knee flexion.
Each target angle will be measured three times, and both knee joints will be tested.
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baseline, 1 day and 4 weeks
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Change of Unified Parkinson's disease rating scale-motor (UPDRS motor)
Time Frame: baseline, 1 day and 4 weeks
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Unified Parkinson's disease rating scale is used to evaluate the disease progression for Parkinson's disease (PD).
Higher scores represent the more advanced disease progression.
It includes four subscales: mentation, behavior and mood, activities of daily living, motor examination, and complications of therapy.
In this study, the investigator mainly use the motor examination subscale.
There are 14 items in motor examination including speech, facial expression, tremor at test, action or postural tremor of hands, rigidity, finger taps, postural stability, gait, body bradykinesia and hypokinesia…etc.
The purpose is to evaluate the motor performance for individuals with PD (Movement Disorder Society Task Force on Rating Scales for Parkinson's, 2003).
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baseline, 1 day and 4 weeks
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Change of balance function (measured by Functional Reach Test)
Time Frame: baseline, 1 day and 4 weeks
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The purpose of functional reach test is used to measure balance function.
Participants can be in standing or sitting position (unable to stand).
It measures the difference of distance in centimeters between arm's length with arms at 90° flexion and maximal forward reach with a fixed base of support.
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baseline, 1 day and 4 weeks
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Change of mobility function (measured by Time up and go test)
Time Frame: baseline, 1 day and 4 weeks
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The purpose of time up and go test (TUG) is to evaluate the mobility function including both static and dynamic balance.
The experimenter uses a stopwatch to measure the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Participants can walk independently or with walking devices.
It is easy to administer and can applied to elderly population.
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baseline, 1 day and 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 28, 2018
Primary Completion (ACTUAL)
June 28, 2019
Study Completion (ACTUAL)
June 28, 2019
Study Registration Dates
First Submitted
December 7, 2018
First Submitted That Met QC Criteria
December 13, 2018
First Posted (ACTUAL)
December 17, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 23, 2020
Last Update Submitted That Met QC Criteria
January 22, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201702010B0C603
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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