RehabilitationNCT03963258
Short-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia
A study testing whole-body vibration training and conventional upper limb training in people with Rehabilitation and Stroke, run by Peking University Third Hospital at 1 site in China.
Trial summary
To investigate the effect of whole body vibration on upper limb motor function in hemiplegic patients with subacute stroke Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rehabilitation, Stroke, Hemiplegia
- What is being tested?
- whole-body vibration training and conventional upper limb training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2019to May 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After unilateral stroke 1 to 6 months
- An ischemic or hemorrhagic poststroke hemiplegia
- No cognitive impairment
- Able to reach Brunnstrom stage II or above in the proximal and distal parts of the arms
- No excessive pain in the more affected upper extremity
- All subjects agreed to participate in the study after receiving explanations regarding the purpose and procedures of the experiment, and they signed an informed consent statement before participation
Who cannot join
- Unsteadiness
- Accompanied by important organs (such as heart, liver, lung, kidney) dysfunction or malignant tumors
- Contraindications to general vibration training exist
- Combined with other diseases causing upper limb dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Univercity Third Hospital
Beijing, No State Or Province, 100191
Hongbo Li, bachelor
About this study
To investigate the effect of whole body vibration on upper limb motor function in hemiplegic patients with subacute stroke
- Conditions
- Rehabilitation, Stroke, Hemiplegia, Physical Therapy Modalities, Electromyography, Upper Extremity
- Being tested
- whole-body vibration training, conventional upper limb training
- Keywords
- Whole-Body vibration, Stroke, Hemiplegia, upper extremity, Rehabilitation training, Muscular surface EMG, Vibration training
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole-body vibration trainingDevice
Also called vibration training
The subjects were exposed to alternating vertical sinusoidal vibration using a Galileo tilting table system.The frequency of WBV ranged from 5 to 20 Hz, and the amplitude ranged from 1 to 6 mm.The subjects were kneeled on the ground, both shoulders flexed at 90 degrees, elbows slightly flexed, their trunk bent in this position and contacted on the platform board with their palms equidistant from the midpoint of the board
conventional upper limb trainingOther
compensatory techniques for activities of daily living, UE strength, therapist-guided techniques for facilitating normal UE movement patterns,and range of motion and traditional positioning
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Over a 3-week period, the subjects in the control group received 1 hour daily of conventional upper limb training 5 times a week,including compensatory techniques for activities of daily living, UE strength, therapist-guided techniques for facilitating normal UE movement patterns,and range of motion and traditional positioning Receives: Other: conventional upper limb training |
| whole-body vibration group | Experimental | Subjects in the whole-body vibration group received half an hour of daily conventional upper limb training, followed by whole-body vibration training for an additional half hour per day,5 days per week during a 3-week period Receives: Device: whole-body vibration training |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper-extremity Fugl-Meyer Scale
the assessment is scored by summing item ratings and reporting the aggregate score out of 66 points,with higher scores representing a greater UE motor ability summing item ratings and reporting the aggregate score out of 66 points, with higher scores representing a greater UE motor ability
Measured: After the 3-week intervention period
Wolf Motor Function Test
participants were timed as they completed 15 activities that progressively involved more difficult arm movements and interactions with objects such as lifting a soda can, stacking checkers, and folding a towel. We reported the average time to perform the 15 items and the evaluator rated the normalcy of these items with a 6-point ordinal scale (range,0-5) using the functional ability scale.
Measured: After the 3-week intervention period
Surface electromyography
Surface electromyography was used to measure the integrated EMG（IEMG）of the biceps and triceps during maximum isometric voluntary contraction（MIVC）of the affected elbow flexion and extension and then the co-contraction rate（CR）was calculated
Measured: After the 3-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start15 Jun 2019
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mouwang Zhou, Peking University Third Hospital
- Investigators
- mouwang zhou, master, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963258
- Sponsor's protocol ID
- IRB00006761-M2018112
- Status last verified
- Jul 2019
- First submitted
- 4 Dec 2018
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia
- ClinicalTrials.gov ID
- NCT03963258
- Acronym / sponsor ID
- IRB00006761-M2018112
- Conditions
- Rehabilitation, Stroke, Hemiplegia, Physical Therapy Modalities, Electromyography, Upper Extremity
- Keywords
- Whole-Body vibration, Stroke, Hemiplegia, upper extremity, Rehabilitation training, Muscular surface EMG, Vibration training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 24 May 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.
To investigate the effect of whole body vibration on upper limb motor function in hemiplegic patients with subacute stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: conventional upper limb trainingOver a 3-week period, the subjects in the control group received 1 hour daily of conventional upper limb training 5 times a week,including compensatory techniques for activities of daily living, UE strength, therapist-guided techniques for facilitating normal UE movement patterns,and range of motion and traditional positioning |
| whole-body vibration group | Experimental | Device: whole-body vibration trainingSubjects in the whole-body vibration group received half an hour of daily conventional upper limb training, followed by whole-body vibration training for an additional half hour per day,5 days per week during a 3-week period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- After unilateral stroke 1 to 6 months
- An ischemic or hemorrhagic poststroke hemiplegia
- No cognitive impairment
- Able to reach Brunnstrom stage II or above in the proximal and distal parts of the arms
- No excessive pain in the more affected upper extremity
Key exclusion criteria (4 listed)
- Unsteadiness
- Accompanied by important organs (such as heart, liver, lung, kidney) dysfunction or malignant tumors
- Contraindications to general vibration training exist
- Combined with other diseases causing upper limb dysfunction
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 trainingAlso: vibration trainingThe subjects were exposed to alternating vertical sinusoidal vibration using a Galileo tilting table system.The frequency of WBV ranged from 5 to 20 Hz, and the amplitude ranged from 1 to 6 mm.The subjects were kneeled on the ground, both shoulders flexed at 90 degrees, elbows slightly flexed, their trunk bent in this position and contacted on the platform board with their palms equidistant from the midpoint of the board | Device | whole-body vibration group |
| conventional upper limb trainingcompensatory techniques for activities of daily living, UE strength, therapist-guided techniques for facilitating normal UE movement patterns,and range of motion and traditional positioning | Other | control group |
Primary outcome
upper-extremity Fugl-Meyer Scale
Time frame: After the 3-week intervention period
the assessment is scored by summing item ratings and reporting the aggregate score out of 66 points,with higher scores representing a greater UE motor ability summing item ratings and reporting the aggregate score out of 66 points, with higher scores representing a greater UE motor ability
Wolf Motor Function Test
Time frame: After the 3-week intervention period
participants were timed as they completed 15 activities that progressively involved more difficult arm movements and interactions with objects such as lifting a soda can, stacking checkers, and folding a towel. We reported the average time to perform the 15 items and the evaluator rated the normalcy of these items with a 6-point ordinal scale (range,0-5) using the functional ability scale.
Surface electromyography
Time frame: After the 3-week intervention period
Surface electromyography was used to measure the integrated EMG（IEMG）of the biceps and triceps during maximum isometric voluntary contraction（MIVC）of the affected elbow flexion and extension and then the co-contraction rate（CR）was calculated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
mouwang zhou, master principal investigator
Peking University Third Hospital
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 training and conventional upper limb training in people with Rehabilitation and Stroke, run by Peking University Third Hospital 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 4 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 2 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mouwang zhou, master (13910092892, zhoumouwang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper-extremity Fugl-Meyer Scale (time frame: After the 3-week intervention period). 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 2 Jul 2019.