StrokeNCT03015545
The Effects of WBV on Muscle Stiffness and Reflex Activity in Stroke.
A study testing paretic leg-WBV and non-paretic leg-WBV in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in the management of spastic hypertonia post-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?
- paretic leg-WBV and non-paretic leg-WBV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2017to 31 Dec 2017
- 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
- Adult with a diagnosis of a hemispheric stroke >6 months,
- Medically stable,
- Able to stand independently for at least 1 minute and
- Mas score >1 measured at the ankle plantar flexors.
Who cannot join
- Brainstem or cerebellar stroke,
- Other neurological condition,
- Serious musculoskeletal or cardiovascular disease,
- Severe contracture of the ankle that the cannot be put in the neutral position.
- Metal implants or recent fractures in the lower extremities or spine,
- Fresh skin wound in lower extremities, especially popliteal fossa
- Other severe illnesses or contraindication for exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Whole Body Vibration (WBV) on Muscle Stiffness and Reflex Activity in People After Stroke.
Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in the management of spastic hypertonia post-stroke. This study aims to investigate the acute effect of WBV on leg muscle H-reflex, stiffness, and blood perfusion in people with chronic stroke.
Read the detailed description
Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in management of spastic hypertonia post-stroke. However, the potential effects of WBV on leg muscle stiffness in stroke rehabilitation remains unknown. Scientific evidence is warranted to fill the knowledge gap.
Purpose This study aims to investigate the acute effect of WBV on leg muscle H-reflex, stiffness and blood perfusion in people with chronic stroke.
Methods Individuals with chronic stroke will be recruited from community self-help groups and existing patient database. Relevant information (e.g. demographic information, medical history) will be obtained from medical records and subject interviews. Each subject will have to fulfill the following inclusion criteria: (1) diagnosis of chronic stroke, (2) community-dwelling, (3) able to follow simple verbal instructions. Exclusion criteria are: (1) other diagnoses of neurological conditions, (2) significant musculoskeletal conditions (e.g. amputations), (3) metal implants in the lower extremity or spine, (4) recent fracture in the lower extremity, (5) diagnosis of osteoporosis, (6) vestibular disorders, (7) peripheral vascular disease, and (11) other serious illnesses or contraindications to exercise.
This is a single-blinded randomized within-patient cross-over study. Each participant was evaluated for the soleus H-reflex, stiffness and blood perfusion of the medial gastrocnemius (MG) using ultrasound on both sides before and after either a 5-minute WBV intervention (30 Hertz, 1.5mm, knee flexed 60 degrees) or a no-WBV condition (5 minutes). The measurements were performed at baseline and every 1-min post-intervention up to 5 minutes. The outcomes generated included the soleus H/M ratio, shear modulus and vascular index (VI) of the MG muscle.
- Conditions
- Stroke
- Being tested
- paretic leg-control, paretic leg-WBV, non-paretic leg-control, non-paretic leg-WBV
- Keywords
- Muscle Stiffness, Ultrasound elastography, H-reflex, Whole body vibration, blood perfusion
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paretic leg-controlDevice
standing on the vibration platform, with no vibration signals delivered.
paretic leg-WBVDevice
standing on the vibration platform, with WBV at 30Hz, 1.5mm.
non-paretic leg-controlDevice
standing on the vibration platform, with no vibration signals delivered.
non-paretic leg-WBVDevice
standing on the vibration platform, with WBV at 30Hz, 1.5mm.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This group will stand with knee flexion 60 degrees on the same vibration platform for 60 seconds for 5 times with 60-seconds rest interval, but no vibration will be given. Receives: Device: paretic leg-control; Device: non-paretic leg-control |
| High intensity whole body vibration | Active comparator | This group will stand with knee flexion 60 degrees on the same vibration platform for 60 seconds for 5 times with 60-seconds rest interval. The whole body vibration platform will be set with frequency at 30Hz and amplitude at 1.5mm. Receives: Device: paretic leg-WBV; Device: non-paretic leg-WBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Measured: Immediately before the intervention
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Measured: 1st minute after the intervention
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Measured: 2nd minute after the intervention
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Measured: 3rd minute after the intervention
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Measured: 4th minute after the intervention
H-reflex of paretic soleus muscle
To measure the efficacy of synaptic transmission
Measured: 5th minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Measured: Immediately before the intervention
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Measured: 1st minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Measured: 2nd minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Measured: 3rd minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Measured: 4th minute after the intervention
Muscle stiffness of paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Measured: 5th minute after the intervention
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Measured: Immediately before the intervention
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Measured: 1st minute after the intervention
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Measured: 2nd minute after the intervention
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Measured: 3rd minute after the intervention
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Measured: 4th minute after the intervention
H-reflex of non-paretic soleus muscle
To measure the efficacy of synaptic transmission
Measured: 5th minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Measured: Immediately before the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Measured: 1st minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Measured: 2nd minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Measured: 3th minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Measured: 4th minute after the intervention
Muscle stiffness of non-paretic medial gastrocnemius
Measured by Supersonic elastography with ankle in neutral position
Measured: 5th minute after the intervention
Secondary outcomes (12)
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Measured: Immediately before the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Measured: 1 minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Measured: 2nd minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Measured: 3rd minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Measured: 4th minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Measured: 5th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Measured: Immediately before the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Measured: 1th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Measured: 2nd minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Measured: 3rd minute after the intervention
MoviIntramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Measured: 4th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Measured by power Doppler ultrasound
Measured: 5th minute after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start1 May 2017
- Primary completion3 Sep 2017
- Study completion31 Dec 2017
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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 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
- Hector WH Tsang, PhD, Study chair, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015545
- Sponsor's protocol ID
- HSEARS20161117007
- Status last verified
- Dec 2018
- First submitted
- 29 Dec 2016
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Whole Body Vibration (WBV) on Muscle Stiffness and Reflex Activity in People After Stroke.
- ClinicalTrials.gov ID
- NCT03015545
- Acronym / sponsor ID
- HSEARS20161117007
- Conditions
- Stroke
- Keywords
- Muscle Stiffness, Ultrasound elastography, H-reflex, Whole body vibration, blood perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 3 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 10 Jan 2017 (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.
Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in the management of spastic hypertonia post-stroke. This study aims to investigate the acute effect of WBV on leg muscle H-reflex, stiffness, and blood perfusion in people with chronic stroke.
Detailed description
Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in management of spastic hypertonia post-stroke. However, the potential effects of WBV on leg muscle stiffness in stroke rehabilitation remains unknown. Scientific evidence is warranted to fill the knowledge gap.
Purpose This study aims to investigate the acute effect of WBV on leg muscle H-reflex, stiffness and blood perfusion in people with chronic stroke.
Methods Individuals with chronic stroke will be recruited from community self-help groups and existing patient database. Relevant information (e.g. demographic information, medical history) will be obtained from medical records and subject interviews. Each subject will have to fulfill the following inclusion criteria: (1) diagnosis of chronic stroke, (2) community-dwelling, (3) able to follow simple verbal instructions. Exclusion criteria are: (1) other diagnoses of neurological conditions, (2) significant musculoskeletal conditions (e.g. amputations), (3) metal implants in the lower extremity or spine, (4) recent fracture in the lower extremity, (5) diagnosis of osteoporosis, (6) vestibular disorders, (7) peripheral vascular disease, and (11) other serious illnesses or contraindications to exercise.
This is a single-blinded randomized within-patient cross-over study. Each participant was evaluated for the soleus H-reflex, stiffness and blood perfusion of the medial gastrocnemius (MG) using ultrasound on both sides before and after either a 5-minute WBV intervention (30 Hertz, 1.5mm, knee flexed 60 degrees) or a no-WBV condition (5 minutes). The measurements were performed at baseline and every 1-min post-intervention up to 5 minutes. The outcomes generated included the soleus H/M ratio, shear modulus and vascular index (VI) of the MG muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: paretic leg-control, Device: non-paretic leg-controlThis group will stand with knee flexion 60 degrees on the same vibration platform for 60 seconds for 5 times with 60-seconds rest interval, but no vibration will be given. |
| High intensity whole body vibration | Active comparator | Device: paretic leg-WBV, Device: non-paretic leg-WBVThis group will stand with knee flexion 60 degrees on the same vibration platform for 60 seconds for 5 times with 60-seconds rest interval. The whole body vibration platform will be set with frequency at 30Hz and amplitude at 1.5mm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult with a diagnosis of a hemispheric stroke >6 months,
- Medically stable,
- Able to stand independently for at least 1 minute and
- Mas score >1 measured at the ankle plantar flexors.
Key exclusion criteria (7 listed)
- Brainstem or cerebellar stroke,
- Other neurological condition,
- Serious musculoskeletal or cardiovascular disease,
- Severe contracture of the ankle that the cannot be put in the neutral position.
- Metal implants or recent fractures in the lower extremities or spine,
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 |
|---|---|---|
| paretic leg-controlstanding on the vibration platform, with no vibration signals delivered. | Device | Control |
| paretic leg-WBVstanding on the vibration platform, with WBV at 30Hz, 1.5mm. | Device | High intensity whole body vibration |
| non-paretic leg-controlstanding on the vibration platform, with no vibration signals delivered. | Device | Control |
| non-paretic leg-WBVstanding on the vibration platform, with WBV at 30Hz, 1.5mm. | Device | High intensity whole body vibration |
Primary outcome
H-reflex of paretic soleus muscle
Time frame: Immediately before the intervention
To measure the efficacy of synaptic transmission
H-reflex of paretic soleus muscle
Time frame: 1st minute after the intervention
To measure the efficacy of synaptic transmission
H-reflex of paretic soleus muscle
Time frame: 2nd minute after the intervention
To measure the efficacy of synaptic transmission
H-reflex of paretic soleus muscle
Time frame: 3rd minute after the intervention
To measure the efficacy of synaptic transmission
H-reflex of paretic soleus muscle
Time frame: 4th minute after the intervention
To measure the efficacy of synaptic transmission
H-reflex of paretic soleus muscle
Time frame: 5th minute after the intervention
To measure the efficacy of synaptic transmission
Muscle stiffness of paretic medial gastrocnemius
Time frame: Immediately before the intervention
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of paretic medial gastrocnemius
Time frame: 1st minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of paretic medial gastrocnemius
Time frame: 2nd minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of paretic medial gastrocnemius
Time frame: 3rd minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of paretic medial gastrocnemius
Time frame: 4th minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of paretic medial gastrocnemius
Time frame: 5th minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
H-reflex of non-paretic soleus muscle
Time frame: Immediately before the intervention
To measure the efficacy of synaptic transmission
H-reflex of non-paretic soleus muscle
Time frame: 1st minute after the intervention
To measure the efficacy of synaptic transmission
H-reflex of non-paretic soleus muscle
Time frame: 2nd minute after the intervention
To measure the efficacy of synaptic transmission
H-reflex of non-paretic soleus muscle
Time frame: 3rd minute after the intervention
To measure the efficacy of synaptic transmission
H-reflex of non-paretic soleus muscle
Time frame: 4th minute after the intervention
To measure the efficacy of synaptic transmission
H-reflex of non-paretic soleus muscle
Time frame: 5th minute after the intervention
To measure the efficacy of synaptic transmission
Muscle stiffness of non-paretic medial gastrocnemius
Time frame: Immediately before the intervention
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of non-paretic medial gastrocnemius
Time frame: 1st minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of non-paretic medial gastrocnemius
Time frame: 2nd minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of non-paretic medial gastrocnemius
Time frame: 3th minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of non-paretic medial gastrocnemius
Time frame: 4th minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
Muscle stiffness of non-paretic medial gastrocnemius
Time frame: 5th minute after the intervention
Measured by Supersonic elastography with ankle in neutral position
12 secondary outcomes
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Time frame: Immediately before the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Time frame: 1 minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Time frame: 2nd minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Time frame: 3rd minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Time frame: 4th minute after the intervention
Intramuscular blood perfusion of paretic medial gastrocnemius muscle
Time frame: 5th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Time frame: Immediately before the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Time frame: 1th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Time frame: 2nd minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Time frame: 3rd minute after the intervention
MoviIntramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Time frame: 4th minute after the intervention
Intramuscular blood perfusion of non-paretic medial gastrocnemius muscle
Time frame: 5th minute after the intervention
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 10 Dec 2018.
- 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.
Hector WH Tsang, PhD study chair
Department of Rehabilitation Sciences, 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 paretic leg-WBV and non-paretic leg-WBV 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 4 inclusion and 7 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 10 Dec 2018. 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?
H-reflex of paretic soleus muscle (time frame: Immediately before the intervention). The study lists 24 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 10 Dec 2018.