Parkinson DiseaseNCT03777501
The Effect of Whole Body Vibration in Individuals With Parkinson's Disease
A study testing non-random whole body vibration and occupational therapy in people with Parkinson Disease, run by Chang Gung University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- non-random whole body vibration and occupational therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Dec 2018to 28 Jun 2019
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- diagnosed with other central nervous system diseases, ex: stroke
- had surgeries in head or arms
- unable to sit for assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
- Conditions
- Parkinson Disease
- Being tested
- non-random whole body vibration, occupational therapy
- Keywords
- proprioception, vibration, balance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-random whole body vibrationBehavioural
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.
occupational therapyBehavioural
Participants will receive the occupational therapy including dynamic balance training and functional ambulatory training.
| Study group | Role | What they receive |
|---|---|---|
| non-random whole body vibration group | Experimental | Each participant will receive the non-random type whole body vibration treatment about one hour after the administration of medicine. Receives: Behavioral: non-random whole body vibration |
| conventional therapy group | Active comparator | For the conventional therapy group, participants will receive the occupational therapy including dynamic balance training and functional ambulatory training. Each session is 10 minutes. Receives: Behavioral: occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in just noticeable difference threshold of proprioceptive sensitivity
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
Measured: baseline, 1 day and 4 weeks
Change of position sense of the knee joint
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.
Measured: baseline, 1 day and 4 weeks
Change of Unified Parkinson's disease rating scale-motor (UPDRS motor)
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).
Measured: baseline, 1 day and 4 weeks
Change of balance function (measured by Functional Reach Test)
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.
Measured: baseline, 1 day and 4 weeks
Change of mobility function (measured by Time up and go test)
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.
Measured: baseline, 1 day and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start28 Dec 2018
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- Model description
- randomized double-blinded controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuan-yi Li, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777501
- Sponsor's protocol ID
- 201702010B0C603
- Status last verified
- Jan 2020
- First submitted
- 7 Dec 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole Body Vibration on Sensorimotor Function in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03777501
- Acronym / sponsor ID
- 201702010B0C603
- Conditions
- Parkinson Disease
- Keywords
- proprioception, vibration, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 17 Dec 2018 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double-blinded controlled trial
| Arm | Type | Receives |
|---|---|---|
| non-random whole body vibration group | Experimental | Behavioral: non-random whole body vibrationEach participant will receive the non-random type whole body vibration treatment about one hour after the administration of medicine. |
| conventional therapy group | Active comparator | Behavioral: occupational therapyFor the conventional therapy group, participants will receive the occupational therapy including dynamic balance training and functional ambulatory training. Each session is 10 minutes. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- diagnosed with other central nervous system diseases, ex: stroke
- had surgeries in head or arms
- unable to sit for assessment
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 |
|---|---|---|
| non-random whole body vibrationEach 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. | Behavioural | non-random whole body vibration group |
| occupational therapyParticipants will receive the occupational therapy including dynamic balance training and functional ambulatory training. | Behavioural | conventional therapy group |
Primary outcome
Change in just noticeable difference threshold of proprioceptive sensitivity
Time frame: baseline, 1 day and 4 weeks
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
Change of position sense of the knee joint
Time frame: baseline, 1 day and 4 weeks
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.
Change of Unified Parkinson's disease rating scale-motor (UPDRS motor)
Time frame: baseline, 1 day and 4 weeks
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).
Change of balance function (measured by Functional Reach Test)
Time frame: baseline, 1 day and 4 weeks
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.
Change of mobility function (measured by Time up and go test)
Time frame: baseline, 1 day and 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-random whole body vibration and occupational therapy in people with Parkinson Disease, run by Chang Gung University at 1 site in Taiwan.
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 8 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jan 2020. 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 Taiwan. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in just noticeable difference threshold of proprioceptive sensitivity (time frame: baseline, 1 day and 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2020.