Brain InjuriesNCT03389113
Effects of Whole-body Vibration Exercise in Brain Injury Patients With Minimally Conscious State
A study testing Whole body vibration and Exersice in people with Brain Injuries and Minimally Conscious State, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effect of the whole body vibration exercise on cortical activity and consciousness Level in brain injury patients with minimally conscious state. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Brain Injuries, Minimally Conscious State
- What is being tested?
- Whole body vibration and Exersice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2017to 31 Dec 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose consciousness level was assessed as minimally conscious state by traumatic brain injury, stroke, and hypoxic brain injury
- Patients who had more than 3 months after brain injury
Who cannot join
- Patients under 18 years of age and older patients over 80 years
- Pregnant women
- In cases of uncontrolled internal or external disease
- Patients with severe heart, musculoskeletal problems and disabilities, and those with severe neurological lesions prior to brain injury
- Acute or chronic venous thrombosis or hemorrhage
- Person wearing an implant on the spine
- People with severe osteoporosis
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Su-Hyun Lee, Msc, +82-10-7147-0433, suhyunlee0811@gmail.com
About this study
Official title: Effects of Whole-body Vibration Exercise on Cortical Activity and Consciousness Level in Brain Injury Patients With Minimally Conscious State: Pilot Study
The purpose of this study is to investigate the effect of the whole body vibration exercise on cortical activity and consciousness Level in brain injury patients with minimally conscious state.
Read the detailed description
Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle strength and postural control. However, there has not yet been a report on the cortical activity changes induced by whole body vibration exercise in brain injury patients with minimally conscious state.
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 assessment were performed using the coma recovery scale-revised and modified ashworth scale.
- Conditions
- Brain Injuries, Minimally Conscious State
- Being tested
- Whole body vibration, Exersice
- Medical subject headings
- Brain Injuries, Persistent Vegetative State
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.
ExersiceOther
Exercise 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 five sessions 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: Exersice |
| Exercise only group | Active comparator | The control group performed the same session without vibration. Receives: Other: Exersice |
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: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Secondary outcomes (2)
Coma Recovery Scale-Revised
assess patients with a disorder of consciousness, commonly coma
The CRS-R consists of 23 items, grouped into 6 sub-scales:
- .Auditory
- Visual
- Motor
- Oromotor
- Communication
- Arousal The lowest score on each sub-scale represents reflexive activity; the highest represents behaviors mediated by cognitive input.
The total score ranges between 0 (worst) and 23 (best). This measure takes a minimum of 25 minutes to complete.
Measured: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Modified Ashworth scale
measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity The Ashworth scale is one of the most widely used methods of measuring spasticity, due in a large part to the simplicity and reproducible method.
0: No increase in muscle tone Grade Description
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
- More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension
Measured: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start2 Jan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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 five sessions 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 sessions without vibration.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
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
- NCT03389113
- Sponsor's protocol ID
- 2016-04-101-004
- Status last verified
- Dec 2017
- First submitted
- 27 Dec 2017
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole-body Vibration Exercise on Cortical Activity and Consciousness Level in Brain Injury Patients With Minimally Conscious State: Pilot Study
- ClinicalTrials.gov ID
- NCT03389113
- Acronym / sponsor ID
- 2016-04-101-004
- Conditions
- Brain Injuries, Minimally Conscious State
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 Jan 2018 (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 consciousness Level in brain injury patients with minimally conscious state.
Detailed description
Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle strength and postural control. However, there has not yet been a report on the cortical activity changes induced by whole body vibration exercise in brain injury patients with minimally conscious state.
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 assessment were performed using the coma recovery scale-revised and modified ashworth scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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 five sessions 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 sessions without vibration.
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration group | Experimental | Device: Whole body vibration, Other: ExersiceWhole body vibration group performed five sessions 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: ExersiceThe 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 (2 listed)
- Patients whose consciousness level was assessed as minimally conscious state by traumatic brain injury, stroke, and hypoxic brain injury
- Patients who had more than 3 months after brain injury
Key exclusion criteria (7 listed)
- Patients under 18 years of age and older patients over 80 years
- Pregnant women
- In cases of uncontrolled internal or external disease
- Patients with severe heart, musculoskeletal problems and disabilities, and those with severe neurological lesions prior to brain injury
- Acute or chronic venous thrombosis or hemorrhage
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 |
| ExersiceExercise maintain 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: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS
2 secondary outcomes
Coma Recovery Scale-Revised
Time frame: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Modified Ashworth scale
Time frame: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
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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.
Yun-Hee Kim, MD, PhD principal investigator
Samsung Medical Center
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 and Exersice in people with Brain Injuries and Minimally Conscious State, run by Samsung Medical Center at 1 site in South Korea.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Sep 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 South Korea. 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 Yun-Hee Kim, MD, PhD (82-2-3410-2824, yunkim@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral cortex activity (time frame: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)). 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 20 Sep 2019.