StrokeNCT03982251
The Effects of Whole Body Vibration in People With Chronic Stroke
A study testing High frequency whole body vibration and Low frequency whole body vibration in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Whole body vibration (WBV) has been found to be useful in promoting bone health and muscle performance in older adults. To date, no study has examined the effects of different WBV frequencies on the properties of the muscle-bone unit in stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- High frequency whole body vibration and Low frequency whole body vibration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Jun 2017to 28 Aug 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a diagnosis of stroke
- stroke onset >6 months
- >18 years of age
- able to walk for short distance independently with or without walking aid
- able to understand simple verbal commands
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
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- 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 Whole Body Vibration Training With Different Frequencies on Bone Health and Neuromotor Performance in Individuals With Chronic Stroke: A Randomized Controlled Trial.
Whole body vibration (WBV) has been found to be useful in promoting bone health and muscle performance in older adults. To date, no study has examined the effects of different WBV frequencies on the properties of the muscle-bone unit in stroke patients. The overall aim of the proposed study is to compare the efficacy of different vibration frequencies on properties of the muscle function and bone turnover among people with chronic stroke.
It is hypothesized that the higher-vibration frequency protocol will lead to significantly better outcomes related to the bone turnover and muscle function.
Read the detailed description
Whole body vibration (WBV) has been found to be useful in promoting bone health and muscle performance in older adults. To date, no study has examined the effects of different WBV frequencies on the properties of the muscle-bone unit in stroke patients. The overall aim of the proposed study is to compare the efficacy of different vibration frequencies on properties of the muscle function and bone turnover among people with chronic stroke.
It is hypothesized that the higher-vibration frequency protocol will lead to significantly better outcomes related to the bone turnover and muscle function in people with chronic stroke.
- Conditions
- Stroke
- Being tested
- High frequency whole body vibration, Low frequency whole body vibration
- Keywords
- vibration, bone, mucle, cerebrovascular accident, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency whole body vibrationProcedure or surgery
Also called Whole body vibration therapy (30Hz)
1 single session ( 8 minutes) of whole body vibration therapy at 30 Hz
Low frequency whole body vibrationProcedure or surgery
Also called Whole body vibration therapy (20Hz)
1 single session ( 12 minutes) of whole body vibration therapy at 20 Hz
| Study group | Role | What they receive |
|---|---|---|
| High frequency whole body vibration | Experimental | This group will receive a single 8-minute session of WBV therapy. The frequency of the vibration signals will be set at 30Hz. Receives: Procedure: High frequency whole body vibration |
| low frequency whole body vibration | Active comparator | This group will receive a single 12-minute session of WBV. The frequency of the vibration signals will be set at 20 Hz. Receives: Procedure: Low frequency whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone resorption marker
Serum level of aminoterminal crosslinked telopeptide
Measured: pre-test (week 0)
bone resorption marker
Serum level of aminoterminal crosslinked telopeptide
Measured: post-test (week8)
Secondary outcomes (6)
Six Minute Walk Test
endurance test
Measured: pre-test (week 0)
Six Minute Walk Test
endurance Test
Measured: post-test (week8)
Gait velocity
10-meter walking test
Measured: pre-test (week 0)
Gait velocity
10-meter walking test
Measured: post-test (week8)
Spasticity
H-reflex on tibial nerve and modified ashworth scale
Measured: pre-test (week 0)
Spasticity
H-reflex on tibial nerve and modified ashworth scale
Measured: post-test (week8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start28 Jun 2017
- Primary completion28 Jun 2018
- Study completion28 Aug 2018
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
- 80 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
- NCT03982251
- Sponsor's protocol ID
- HSEARS20140226001-03
- Status last verified
- Jun 2019
- First submitted
- 6 Jun 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Whole Body Vibration Training With Different Frequencies on Bone Health and Neuromotor Performance in Individuals With Chronic Stroke: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03982251
- Acronym / sponsor ID
- HSEARS20140226001-03
- Conditions
- Stroke
- Keywords
- vibration, bone, mucle, cerebrovascular accident, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 11 Jun 2019 (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.
Whole body vibration (WBV) has been found to be useful in promoting bone health and muscle performance in older adults. To date, no study has examined the effects of different WBV frequencies on the properties of the muscle-bone unit in stroke patients. The overall aim of the proposed study is to compare the efficacy of different vibration frequencies on properties of the muscle function and bone turnover among people with chronic stroke.
It is hypothesized that the higher-vibration frequency protocol will lead to significantly better outcomes related to the bone turnover and muscle function.
Detailed description
Whole body vibration (WBV) has been found to be useful in promoting bone health and muscle performance in older adults. To date, no study has examined the effects of different WBV frequencies on the properties of the muscle-bone unit in stroke patients. The overall aim of the proposed study is to compare the efficacy of different vibration frequencies on properties of the muscle function and bone turnover among people with chronic stroke.
It is hypothesized that the higher-vibration frequency protocol will lead to significantly better outcomes related to the bone turnover and muscle function in people with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High frequency whole body vibration | Experimental | Procedure: High frequency whole body vibrationThis group will receive a single 8-minute session of WBV therapy. The frequency of the vibration signals will be set at 30Hz. |
| low frequency whole body vibration | Active comparator | Procedure: Low frequency whole body vibrationThis group will receive a single 12-minute session of WBV. The frequency of the vibration signals will be set at 20 Hz. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a diagnosis of stroke
- stroke onset >6 months
- >18 years of age
- able to walk for short distance independently with or without walking aid
- able to understand simple verbal commands
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 |
|---|---|---|
| High frequency whole body vibrationAlso: Whole body vibration therapy (30Hz)1 single session ( 8 minutes) of whole body vibration therapy at 30 Hz | Procedure or surgery | High frequency whole body vibration |
| Low frequency whole body vibrationAlso: Whole body vibration therapy (20Hz)1 single session ( 12 minutes) of whole body vibration therapy at 20 Hz | Procedure or surgery | low frequency whole body vibration |
Primary outcome
bone resorption marker
Time frame: pre-test (week 0)
Serum level of aminoterminal crosslinked telopeptide
bone resorption marker
Time frame: post-test (week8)
Serum level of aminoterminal crosslinked telopeptide
6 secondary outcomes
Six Minute Walk Test
Time frame: pre-test (week 0)
Six Minute Walk Test
Time frame: post-test (week8)
Gait velocity
Time frame: pre-test (week 0)
Gait velocity
Time frame: post-test (week8)
Spasticity
Time frame: pre-test (week 0)
Spasticity
Time frame: post-test (week8)
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 11 Jun 2019.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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 High frequency whole body vibration and Low frequency whole body vibration in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 5 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 11 Jun 2019. 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 Hong Kong. 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?
bone resorption marker (time frame: pre-test (week 0)). The study lists 2 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 11 Jun 2019.