StrokeNCT00937339
Effects of Whole Body Vibration in People With Chronic Stroke
A study testing Whole body vibration therapy and Exercise on the vibration platform with the device turned off in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone health, physical fitness and neuromotor performance in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Whole body vibration therapy and Exercise on the vibration platform with the device turned off
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- Jul 2009to Jul 2011
- 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
- a diagnosis of stroke more than 6 months
- medically stable
- able to understand verbal commands
- Abbreviated mental test score 6 or above
- age >18
- able to stand with or without aids for at least 1.5 minutes
Who cannot join
- neurological conditions other than stroke
- significant musculoskeletal conditions (e.g. amputations)
- metal implants in the lower extremity
- previous fracture of the lower extremity
- are currently taking bone resorption inhibitors or were taking the same before stroke.
- significant peripheral vascular disease
Show all 9Show fewer
- vestibular disorders
- pregnancy
- Other serious illnesses that preclude the person from participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Exercise and Whole Body Vibration Training on Bone Health, Physical Fitness, and Neuromotor Performance in Individuals With Chronic Stroke: A Randomized Controlled Trial.
The overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone health, physical fitness and neuromotor performance in patients with chronic stroke.
Subjects in the experimental group will undergo whole body vibration therapy (1 session per day, 3 sessions per week) for 8 weeks. The vibration frequency used in this study will be 30Hz. The total duration of exposure to vibration for the experimental group will be 10 minutes. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2) deep squatting, (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The control exercise group, on the other hand, will perform the same exercise program on the platform, but no vibration will be given. The training will be conducted by a qualified personnel with physiotherapy background.
The outcome measurement will be performed 4 times: (1) immediately before the commencement of intervention, (2) immediately after termination of treatment, (3) at 1 month after termination of treatment. Each subject will be evaluated for bone markers, leg muscle strength, balance, spasticity, and walking ability.
- Conditions
- Stroke
- Being tested
- Whole body vibration therapy, Exercise on the vibration platform with the device turned off
- Keywords
- cerebrovascular accident, bone, muscle, vibration
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration therapyDevice
Also called Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)
Experimental group: One session per day, 3 sessions per week, for consecutive 8 weeks. The total duration of whole body vibration therapy will be about 10 minutes per session.
Exercise on the vibration platform with the device turned offDevice
Also called Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)
Control group: One session per day, 3 sessions per week, for consecutive 8 weeks. The subjects will perform the same exercises on the vibration platform but no vibration will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The control group will perform the same exercises on the vibration platform, as in the experimental group. However, the vibration device will be turned off during the exercises. Receives: Device: Exercise on the vibration platform with the device turned off |
| Whole body vibration | Experimental | Subjects in the experimental group will undergo whole body vibration (1 session per day, 3 sessions per week) for 8 weeks. The vibration loading will be carried out using the Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea). The vibration protocol used in this study will be 30Hz. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2)deep squatting , (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The total duration of exposure of whole body vibration per session will be about 10 minutes. Receives: Device: Whole body vibration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paretic knee concentric muscle strength
Measured: pre-test (week 0)
Paretic knee concentric muscle strength
Measured: Post-test (week 8)
Paretic knee concentric muscle strength
Measured: Follow-up (week 12)
Secondary outcomes (44)
Non-paretic concentric knee muscle strength
Measured: Pre-test (week 0)
Non-paretic knee concentric muscle strength
Measured: Post-test (week 8)
Non-paretic knee concentric muscle strength
Measured: Follow-up (week 12)
Paretic knee eccentric muscle strength
Measured: pre-test (week 0)
Paretic knee eccentric muscle strength
Measured: Post-test (week 8)
Paretic knee eccentric muscle strength
Measured: WFollow-up (week 12)
Non-paretic knee eccentric muscle strength
Measured: Pre-test (week 0)
Non-paretic knee eccentric muscle strength
Measured: Post-test (week 8)
Non-paretic knee eccentric muscle strength
Measured: Follow-up (week 12)
Paretic knee isometric muscle strength
Measured: Pre-test (week 0)
Paretic knee isometric muscle strength
Measured: Post-test (week 8)
Paretic knee isometric muscle strength
Measured: Follow-up (week 12)
Non-paretic knee isometric muscle strength
Measured: Pre-test (week 0)
Non-paretic knee isometric muscle strength
Measured: Post-test (week 8)
Non-paretic knee isometric muscle strength
Measured: Follow-up (week 12)
Limit of stability test
Measured: Pre-test (week 0)
Limit of stability test
Measured: Post-test (week 8)
Limit of stability test
Measured: Follow-up (week 12)
Berg balance test
Measured: Pre-test (week 0)
Berg balance test
Measured: Post-test (week 12)
Berg balance test
Measured: Follow-up (week 12)
Activities-specific Balance Confidence Scale
Measured: Pre-test (week 0)
Activities-specific Balance Confidence Scale
Measured: Post-test (week 8)
Activities-specific Balance Confidence Scale
Measured: Follow-up (week 12)
Six Minute Walk Test
Measured: Pre-test (week 0)
Six Minute Walk Test
Measured: Post-test (week 8)
Six Minute Walk Test
Measured: Follow-up (week 12)
Self-selected gait velocity
Measured: Pre-test (week 0)
Self-selected gait velocity
Measured: post-test (week 8)
Self-selected gait velocity
Measured: Follow-up (week 12)
Bone formation marker level
Measured: pre-test (week 0)
Bone formation marker level
Measured: Post-test (week 8)
Bone resorption marker level
Measured: pre-test (week 0)
Bone formation marker level
Measured: Follow-up (week 12)
Bone resorption marker level
Measured: post-test (week 8)
Bone resorption marker level
Measured: Follow-up (week 12)
fall rate
Measured: 6 months after termination of treatment
Knee spasticity
Measured: Pre-test (week 0)
Knee spasticity
Measured: Post-test (week 8)
Knee spasticity
Measured: Follow-up (week 12)
Ankle spasticity
Measured: Pre-test (week 0)
Ankle spasticity
Measured: Post-test (week 8)
Ankle spasticity
Measured: Follow-up (week 12)
Level of satisfaction
Measured: Post-test (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Yiu-Chung Pang, The Hong Kong Polytechnic University
- Investigators
- Marco YC Pang, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937339
- Sponsor's protocol ID
- HSEARS20090520002-01
- Status last verified
- Apr 2013
- First submitted
- 10 Jul 2009
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise and Whole Body Vibration Training on Bone Health, Physical Fitness, and Neuromotor Performance in Individuals With Chronic Stroke: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00937339
- Acronym / sponsor ID
- HSEARS20090520002-01
- Conditions
- Stroke
- Keywords
- cerebrovascular accident, bone, muscle, vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 13 Jul 2009 (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.
The overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone health, physical fitness and neuromotor performance in patients with chronic stroke.
Subjects in the experimental group will undergo whole body vibration therapy (1 session per day, 3 sessions per week) for 8 weeks. The vibration frequency used in this study will be 30Hz. The total duration of exposure to vibration for the experimental group will be 10 minutes. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2) deep squatting, (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The control exercise group, on the other hand, will perform the same exercise program on the platform, but no vibration will be given. The training will be conducted by a qualified personnel with physiotherapy background.
The outcome measurement will be performed 4 times: (1) immediately before the commencement of intervention, (2) immediately after termination of treatment, (3) at 1 month after termination of treatment. Each subject will be evaluated for bone markers, leg muscle strength, balance, spasticity, and walking ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Exercise on the vibration platform with the device turned offThe control group will perform the same exercises on the vibration platform, as in the experimental group. However, the vibration device will be turned off during the exercises. |
| Whole body vibration | Experimental | Device: Whole body vibration therapySubjects in the experimental group will undergo whole body vibration (1 session per day, 3 sessions per week) for 8 weeks. The vibration loading will be carried out using the Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea). The vibration protocol used in this study will be 30Hz. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2)deep squatting , (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The total duration of exposure of whole body vibration per session will be about 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- a diagnosis of stroke more than 6 months
- medically stable
- able to understand verbal commands
- Abbreviated mental test score 6 or above
- age >18
Key exclusion criteria (9 listed)
- neurological conditions other than stroke
- significant musculoskeletal conditions (e.g. amputations)
- metal implants in the lower extremity
- previous fracture of the lower extremity
- are currently taking bone resorption inhibitors or were taking the same before stroke.
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 |
|---|---|---|
| Whole body vibration therapyAlso: Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)Experimental group: One session per day, 3 sessions per week, for consecutive 8 weeks. The total duration of whole body vibration therapy will be about 10 minutes per session. | Device | Whole body vibration |
| Exercise on the vibration platform with the device turned offAlso: Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)Control group: One session per day, 3 sessions per week, for consecutive 8 weeks. The subjects will perform the same exercises on the vibration platform but no vibration will be applied. | Device | Control |
Primary outcome
Paretic knee concentric muscle strength
Time frame: pre-test (week 0)
Paretic knee concentric muscle strength
Time frame: Post-test (week 8)
Paretic knee concentric muscle strength
Time frame: Follow-up (week 12)
44 secondary outcomes
Non-paretic concentric knee muscle strength
Time frame: Pre-test (week 0)
Non-paretic knee concentric muscle strength
Time frame: Post-test (week 8)
Non-paretic knee concentric muscle strength
Time frame: Follow-up (week 12)
Paretic knee eccentric muscle strength
Time frame: pre-test (week 0)
Paretic knee eccentric muscle strength
Time frame: Post-test (week 8)
Paretic knee eccentric muscle strength
Time frame: WFollow-up (week 12)
Non-paretic knee eccentric muscle strength
Time frame: Pre-test (week 0)
Non-paretic knee eccentric muscle strength
Time frame: Post-test (week 8)
Non-paretic knee eccentric muscle strength
Time frame: Follow-up (week 12)
Paretic knee isometric muscle strength
Time frame: Pre-test (week 0)
Paretic knee isometric muscle strength
Time frame: Post-test (week 8)
Paretic knee isometric muscle strength
Time frame: Follow-up (week 12)
Non-paretic knee isometric muscle strength
Time frame: Pre-test (week 0)
Non-paretic knee isometric muscle strength
Time frame: Post-test (week 8)
Non-paretic knee isometric muscle strength
Time frame: Follow-up (week 12)
Limit of stability test
Time frame: Pre-test (week 0)
Limit of stability test
Time frame: Post-test (week 8)
Limit of stability test
Time frame: Follow-up (week 12)
Berg balance test
Time frame: Pre-test (week 0)
Berg balance test
Time frame: Post-test (week 12)
Berg balance test
Time frame: Follow-up (week 12)
Activities-specific Balance Confidence Scale
Time frame: Pre-test (week 0)
Activities-specific Balance Confidence Scale
Time frame: Post-test (week 8)
Activities-specific Balance Confidence Scale
Time frame: Follow-up (week 12)
Six Minute Walk Test
Time frame: Pre-test (week 0)
Six Minute Walk Test
Time frame: Post-test (week 8)
Six Minute Walk Test
Time frame: Follow-up (week 12)
Self-selected gait velocity
Time frame: Pre-test (week 0)
Self-selected gait velocity
Time frame: post-test (week 8)
Self-selected gait velocity
Time frame: Follow-up (week 12)
Bone formation marker level
Time frame: pre-test (week 0)
Bone formation marker level
Time frame: Post-test (week 8)
Bone resorption marker level
Time frame: pre-test (week 0)
Bone formation marker level
Time frame: Follow-up (week 12)
Bone resorption marker level
Time frame: post-test (week 8)
Bone resorption marker level
Time frame: Follow-up (week 12)
fall rate
Time frame: 6 months after termination of treatment
Knee spasticity
Time frame: Pre-test (week 0)
Knee spasticity
Time frame: Post-test (week 8)
Knee spasticity
Time frame: Follow-up (week 12)
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 4 Apr 2013.
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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.
Marco YC Pang, PhD principal investigator
The Hong Kong Polytechnic 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 Whole body vibration therapy and Exercise on the vibration platform with the device turned off in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in China.
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 9 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 4 Apr 2013. 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 China. 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?
Paretic knee concentric muscle strength (time frame: pre-test (week 0)). The study lists 3 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 4 Apr 2013.