StrokeNCT03375346
Effects of Whole-body Vibration Exercise on Stroke Patients
A study testing Whole body vibration and Exercise in people with Stroke and Hemiplegia, run by Samsung Medical Center.
Trial summary
The purpose of this study is to investigate the effect of the whole body vibration exercise on cortical activity and gait function in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Whole body vibration and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 4 Aug 2015to 3 Aug 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral stroke with hemiplegia
- 3 months after stroke onset
- Able to walk at least 10 meters without assistive devices
Who cannot join
- Subjects under 18 years and above 80 years old,
- Unable to perform a half squat on a vibrator (eg. visual field defects, fracture, and severe muscle paralysis)
- Musculoskeletal disorders
- Risk of falling due to dizziness
- Pregnant women
About this study
Official title: Effects of Whole-body Vibration Exercise on Brain Activity and Physical Function in Hemiplegia Stroke Patients
The purpose of this study is to investigate the effect of the whole body vibration exercise on cortical activity and gait function in patients with chronic stroke.
Read the detailed description
Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle strength and postural control in stroke patients. However, there has not yet been a report on the cortical activity changes induced by whole body vibration exercise.
Patients will be randomly assigned to one of the two groups. One group will go through whole body vibration with exercise and the other will only perform exercise. The primary outcome measurement of this study was cerebral cortex activity based on changes in oxygenated hemoglobin concentration using functional near-infrared spectroscopy. Behavioral assessments were performed before and after the intervention session using the 10-meter walk test, timed up and go test, Fugl-Meyer Assessment, and Tinetti Performance Oriented Mobility Assessment.
- Conditions
- Stroke, Hemiplegia
- Being tested
- Whole body vibration, Exercise
- Keywords
- Whole body vibration exercise
- 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 vibrationDevice
whole body vibration exercise is a stimulus that uses vibrations generated on a machine with oscillatory movement determined by the amplitude and frequency of the vibration.
ExerciseOther
maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration group | Experimental | Whole body vibration group performed a single session of whole body vibration exercise via a vibrating platform (Galileo® Advanced Plus, Novotec Medical, Pforzheim, Germany) with a magnitude of 20 Hz and an amplitude of 4 mm. Receives: Device: Whole body vibration; Other: Exercise |
| Exercise only group | Active comparator | The control group performed the same session without vibration. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral cortex activity
cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS
Measured: check before, during and directly after intervention(for approximately 14 minutes)
Secondary outcomes (4)
10 meter walk test
performance measure used to assess walking speed in metres per second over a short distance. It can be Blender3D NormalWalkCycle.gifemployed to determine functional mobility, gait, and vestibular function.
Measured: before and after intervention(Approximately 14 minutes)
Timed up and go test
test for gait speed and gait balance
Measured: before and after intervention(Approximately 14 minutes)
Fugl-Meyer Assessment
a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Measured: before and after intervention(Approximately 14 minutes)
Tinetti Performance Oriented Mobility Assessment
Task-oriented outcome measure that assesses gait and balance ability; is composed of a 9-item gait portion (POMA-G) and 7-item balance portion (POMA-B)
Measured: before and after intervention(Approximately 14 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start4 Aug 2015
- Primary completion3 Aug 2017
- Study completion3 Aug 2017
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.
- More trials run by Samsung Medical CenterThe 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
- Model description
- Eligible patients were randomly assigned to one of the two groups in a 1:1 ratio using an odd or even random numbers table. Whole body vibration group performed a single session of whole body vibration exercise via a vibrating platform (Galileo® Advanced Plus, Novotec Medical, Pforzheim, Germany) with a magnitude of 20 Hz and an amplitude of 4 mm. The control group performed the same session without vibration.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun-Hee Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375346
- Sponsor's protocol ID
- 2015-07-092
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee A, Kim H, Kim J, Choi DS, Jung JH, Lee J, Kim YH. Modulating Effects of Whole-body Vibration on Cortical Activity and Gait Function in Chronic Stroke Patients. Brain Neurorehabil. 2020 Mar 26;13(2):e12. doi: 10.12786/bn.2020.13.e12. eCollection 2020 Jul.
PubMed 36744184
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole-body Vibration Exercise on Brain Activity and Physical Function in Hemiplegia Stroke Patients
- ClinicalTrials.gov ID
- NCT03375346
- Acronym / sponsor ID
- 2015-07-092
- Conditions
- Stroke, Hemiplegia
- Keywords
- Whole body vibration exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 4 Aug 2015 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 18 Dec 2017 (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.
The purpose of this study is to investigate the effect of the whole body vibration exercise on cortical activity and gait function in patients with chronic stroke.
Detailed description
Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle strength and postural control in stroke patients. However, there has not yet been a report on the cortical activity changes induced by whole body vibration exercise.
Patients will be randomly assigned to one of the two groups. One group will go through whole body vibration with exercise and the other will only perform exercise. The primary outcome measurement of this study was cerebral cortex activity based on changes in oxygenated hemoglobin concentration using functional near-infrared spectroscopy. Behavioral assessments were performed before and after the intervention session using the 10-meter walk test, timed up and go test, Fugl-Meyer Assessment, and Tinetti Performance Oriented Mobility Assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Eligible patients were randomly assigned to one of the two groups in a 1:1 ratio using an odd or even random numbers table. Whole body vibration group performed a single session of whole body vibration exercise via a vibrating platform (Galileo® Advanced Plus, Novotec Medical, Pforzheim, Germany) with a magnitude of 20 Hz and an amplitude of 4 mm. The control group performed the same session without vibration.
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration group | Experimental | Device: Whole body vibration, Other: ExerciseWhole body vibration group performed a single session of whole body vibration exercise via a vibrating platform (Galileo® Advanced Plus, Novotec Medical, Pforzheim, Germany) with a magnitude of 20 Hz and an amplitude of 4 mm. |
| Exercise only group | Active comparator | Other: ExerciseThe control group performed the same session without vibration. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral stroke with hemiplegia
- 3 months after stroke onset
- Able to walk at least 10 meters without assistive devices
Key exclusion criteria (5 listed)
- Subjects under 18 years and above 80 years old,
- Unable to perform a half squat on a vibrator (eg. visual field defects, fracture, and severe muscle paralysis)
- Musculoskeletal disorders
- Risk of falling due to dizziness
- Pregnant women
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 vibrationwhole body vibration exercise is a stimulus that uses vibrations generated on a machine with oscillatory movement determined by the amplitude and frequency of the vibration. | Device | Whole body vibration group |
| Exercisemaintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees | Other | Exercise only group, Whole body vibration group |
Primary outcome
Cerebral cortex activity
Time frame: check before, during and directly after intervention(for approximately 14 minutes)
cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS
4 secondary outcomes
10 meter walk test
Time frame: before and after intervention(Approximately 14 minutes)
Timed up and go test
Time frame: before and after intervention(Approximately 14 minutes)
Fugl-Meyer Assessment
Time frame: before and after intervention(Approximately 14 minutes)
Tinetti Performance Oriented Mobility Assessment
Time frame: before and after intervention(Approximately 14 minutes)
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 20 Dec 2017.
- Derived from this study: PubMed 36744184Lee A, Kim H, Kim J, Choi DS, Jung JH, Lee J, Kim YH. Modulating Effects of Whole-body Vibration on Cortical Activity and Gait Function in Chronic Stroke Patients. Brain Neurorehabil. 2020 Mar 26;13(2):e12. doi: 10.12786/bn.2020.13.e12. eCollection 2020 Jul.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Yun-Hee Kim, MD, PhD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration and Exercise in people with Stroke and Hemiplegia, run by Samsung Medical Center.
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 3 inclusion and 5 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 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Cerebral cortex activity (time frame: check before, during and directly after intervention(for approximately 14 minutes)). 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 NCT03375346, 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 20 Dec 2017.