StrokeNCT01822704
Whole Body Vibration in Chronic Stroke
A study testing Low intensity whole body vibration, High intensity whole body vibration and Leg exercises in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study is a randomized controlled trial aimed to assess the efficacy of a 10-week whole body vibration training program on physical functioning, societal participation and quality of life in individuals 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?
- Low intensity whole body vibration, High intensity whole body vibration and Leg exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2013to May 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
- diagnosis of a hemispheric stroke
- chronic stroke (onset of 6 months or more)
- aged 18 years or older
- medically stable
- able to stand for at least 1 minute with hand support
- Abbreviated Mental Test score at 6 or more
- Chedoke McMaster Stroke Assessment leg or foot score less than 7 points
Who cannot join
- recurrent stroke
- brainstem or cerebellar stroke
- other neurological conditions
- significant musculoskeletal conditions (e.g. amputations)
- vestibular disorders
- peripheral vascular disease
- other serious illnesses
- other contraindications to exercise.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hung Hom, Kowloon
Alan Liao, MPT, 852-2766-4845, lr-liao@126.com
Marco Y Pang, PhD
About this study
Official title: Application of Vertical Whole Body Vibration in Stroke Patients: Neuromuscular Effects, and Clinical Efficacy
This study is a randomized controlled trial aimed to assess the efficacy of a 10-week whole body vibration training program on physical functioning, societal participation and quality of life in individuals with chronic stroke. It is hypothesized that the whole body vibration program will induce significantly more gain in physical functioning, societal participation, and quality of life in chronic stroke patients, compared with the control group.
- Conditions
- Stroke
- Being tested
- Low intensity whole body vibration, High intensity whole body vibration, Leg exercises
- Keywords
- Stroke, Exercise, Rehabilitation, Vibration
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity whole body vibrationDevice
High intensity whole body vibrationDevice
Leg exercisesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This group will undergo three 45-minute exercise sessions per week for 10 weeks. No whole body vibration will be given. Receives: Behavioral: Leg exercises |
| Low intensity vibration | Experimental | This group will receive three 45-minute whole body vibration training sessions for 10 consecutive weeks. The vibration will be of low intensity (frequency: 20 Hertz, amplitude: 1mm). Receives: Device: Low intensity whole body vibration; Behavioral: Leg exercises |
| High intensity vibration | Experimental | This group will receive three 45-minute whole body vibration training sessions per week for 10 consecutive weeks.The vibration will be of higher intensity than the low intensity vibration group (frequency: 30 Hertz, amplitude: 1mm). Receives: Device: High intensity whole body vibration; Behavioral: Leg exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric knee muscle strength
Measured: Week 0
Isometric knee muscle strength
Measured: week 10
Secondary outcomes (28)
Eccentric knee muscle strength at a velocity of 60 degrees per second
Measured: Week 0
Eccentric knee muscle strength at a velocity of 60 degrees per second
Measured: week 10
Concentric knee muscle strength at a velocity of 60 degrees per second
Measured: week 0
Concentric knee muscle strength at a velocity of 60 degrees per second
Measured: week 10
Distance walked in the Six Minute Walk Test
Measured: week 0
Distance walked in the Six Minute Walk Test
Measured: week 10
Average oxygen consumption rate during the Six Minute Walk Test
Measured: week 0
Average oxygen consumption rate during the Six Minute Walk Test
Measured: week 10
Time taken to complete the Timed Up and Go Test
Measured: week 0
Time taken to complete the Timed Up and Go Test
Measured: week 10
Time taken to complete the Five-times-sit-to-stand test
Measured: week 0
Time taken to complete the Five-times-sit-to-stand test
Measured: week 10
Distance reached in the Functional Reach test
Measured: Week 0
Distance reached in the Functional Reach test
Measured: week 10
Balance score as measured by the Mini-Balance Evaluation Systems Test
Measured: week 0
Balance score as measured by the Mini-Balance Evaluation Systems Test
Measured: week 10
Walking ability as measured by the Functional Ambulation Category
Measured: week 0
Walking ability as measured by the Functional Ambulation Category
Measured: week 10
Balance confidence scores as measured by the Activities-specific Balance Confidence Scale
Measured: week 0
Balance confidence scores as measured by the Activities-specific Balance Confidence Scale
Measured: week 10
Quality of life score as measured by the 12-item Short Form Health Survey
Measured: week 0
Quality of life score as measured by the 12-item Short Form Health Survey
Measured: week 10
Level of activity participation as measured by the Frenchay Activities Index
Measured: week 0
Level of activity participation as measured by the Frenchay Activities Index
Measured: Week 10
Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors
Measured: week 0
Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors
Measured: week 10
Ankle spasticity score as measured by the Modified Ashworth Scale
Measured: week 0
Ankle spasticity score as measured by the Modified Ashworth Scale
Measured: week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2014 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (estimated)
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
- NCT01822704
- Sponsor's protocol ID
- HSEARS20130209001
- Status last verified
- Apr 2013
- First submitted
- 28 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lau RW, Yip SP, Pang MY. Whole-body vibration has no effect on neuromotor function and falls in chronic stroke. Med Sci Sports Exerc. 2012 Aug;44(8):1409-18. doi: 10.1249/MSS.0b013e31824e4f8c.
PubMed 22330025
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
- Application of Vertical Whole Body Vibration in Stroke Patients: Neuromuscular Effects, and Clinical Efficacy
- ClinicalTrials.gov ID
- NCT01822704
- Acronym / sponsor ID
- HSEARS20130209001
- Conditions
- Stroke
- Keywords
- Stroke, Exercise, Rehabilitation, Vibration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 2 Apr 2013 (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 is a randomized controlled trial aimed to assess the efficacy of a 10-week whole body vibration training program on physical functioning, societal participation and quality of life in individuals with chronic stroke. It is hypothesized that the whole body vibration program will induce significantly more gain in physical functioning, societal participation, and quality of life in chronic stroke patients, compared with the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Leg exercisesThis group will undergo three 45-minute exercise sessions per week for 10 weeks. No whole body vibration will be given. |
| Low intensity vibration | Experimental | Device: Low intensity whole body vibration, Behavioral: Leg exercisesThis group will receive three 45-minute whole body vibration training sessions for 10 consecutive weeks. The vibration will be of low intensity (frequency: 20 Hertz, amplitude: 1mm). |
| High intensity vibration | Experimental | Device: High intensity whole body vibration, Behavioral: Leg exercisesThis group will receive three 45-minute whole body vibration training sessions per week for 10 consecutive weeks.The vibration will be of higher intensity than the low intensity vibration group (frequency: 30 Hertz, amplitude: 1mm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosis of a hemispheric stroke
- chronic stroke (onset of 6 months or more)
- aged 18 years or older
- medically stable
- able to stand for at least 1 minute with hand support
Key exclusion criteria (8 listed)
- recurrent stroke
- brainstem or cerebellar stroke
- other neurological conditions
- significant musculoskeletal conditions (e.g. amputations)
- vestibular disorders
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 |
|---|---|---|
| Low intensity whole body vibration | Device | Low intensity vibration |
| High intensity whole body vibration | Device | High intensity vibration |
| Leg exercises | Behavioural | Control, High intensity vibration, Low intensity vibration |
Primary outcome
Isometric knee muscle strength
Time frame: Week 0
Isometric knee muscle strength
Time frame: week 10
28 secondary outcomes
Eccentric knee muscle strength at a velocity of 60 degrees per second
Time frame: Week 0
Eccentric knee muscle strength at a velocity of 60 degrees per second
Time frame: week 10
Concentric knee muscle strength at a velocity of 60 degrees per second
Time frame: week 0
Concentric knee muscle strength at a velocity of 60 degrees per second
Time frame: week 10
Distance walked in the Six Minute Walk Test
Time frame: week 0
Distance walked in the Six Minute Walk Test
Time frame: week 10
Average oxygen consumption rate during the Six Minute Walk Test
Time frame: week 0
Average oxygen consumption rate during the Six Minute Walk Test
Time frame: week 10
Time taken to complete the Timed Up and Go Test
Time frame: week 0
Time taken to complete the Timed Up and Go Test
Time frame: week 10
Time taken to complete the Five-times-sit-to-stand test
Time frame: week 0
Time taken to complete the Five-times-sit-to-stand test
Time frame: week 10
Distance reached in the Functional Reach test
Time frame: Week 0
Distance reached in the Functional Reach test
Time frame: week 10
Balance score as measured by the Mini-Balance Evaluation Systems Test
Time frame: week 0
Balance score as measured by the Mini-Balance Evaluation Systems Test
Time frame: week 10
Walking ability as measured by the Functional Ambulation Category
Time frame: week 0
Walking ability as measured by the Functional Ambulation Category
Time frame: week 10
Balance confidence scores as measured by the Activities-specific Balance Confidence Scale
Time frame: week 0
Balance confidence scores as measured by the Activities-specific Balance Confidence Scale
Time frame: week 10
Quality of life score as measured by the 12-item Short Form Health Survey
Time frame: week 0
Quality of life score as measured by the 12-item Short Form Health Survey
Time frame: week 10
Level of activity participation as measured by the Frenchay Activities Index
Time frame: week 0
Level of activity participation as measured by the Frenchay Activities Index
Time frame: Week 10
Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors
Time frame: week 0
Level of perceived environmental barriers as measured by the Craig Hospital Inventory of Environmental Factors
Time frame: week 10
Ankle spasticity score as measured by the Modified Ashworth Scale
Time frame: week 0
Ankle spasticity score as measured by the Modified Ashworth Scale
Time frame: week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Background: PubMed 22330025Lau RW, Yip SP, Pang MY. Whole-body vibration has no effect on neuromotor function and falls in chronic stroke. Med Sci Sports Exerc. 2012 Aug;44(8):1409-18. doi: 10.1249/MSS.0b013e31824e4f8c.
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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 Low intensity whole body vibration, High intensity whole body vibration and Leg exercises 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 7 inclusion and 8 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 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco YC Pang, PhD (852-2766-7156, Marco.Pang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric knee muscle strength (time frame: 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?
On the ClinicalTrials.gov record for NCT01822704, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 1 Nov 2026.