Back to resultsEffects of Whole-body Vibration Exercise in Brain Injury Patients With Minimally Conscious State
Primary Purpose
Brain Injuries, Minimally Conscious State
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Whole body vibration
Exersice
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injuries
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Whole body vibration group
Exercise only group
Arm Description
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 session without vibration.
Outcomes
Primary Outcome Measures
Cerebral cortex activity
Cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT03389113
First Posted
December 27, 2017
Last Updated
September 19, 2019
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03389113
Brief Title
Effects of Whole-body Vibration Exercise in Brain Injury Patients With Minimally Conscious State
Official Title
Effects of Whole-body Vibration Exercise on Cortical Activity and Consciousness Level in Brain Injury Patients With Minimally Conscious State: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Minimally Conscious State
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Whole body vibration group
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise only group
Arm Type
Active Comparator
Arm Description
The control group performed the same session without vibration.
Intervention Type
Device
Intervention Name(s)
Whole body vibration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exersice
Intervention Description
Exercise maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees.
Primary Outcome Measure Information:
Title
Cerebral cortex activity
Description
Cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS
Time Frame
session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Secondary Outcome Measure Information:
Title
Coma Recovery Scale-Revised
Description
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.
Time Frame
session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Title
Modified Ashworth scale
Description
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
Time Frame
session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun-Hee Kim, MD, PhD
Phone
82-2-3410-2824
Email
yunkim@skku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Hee Kim, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su-Hyun Lee, Msc
Phone
+82-10-7147-0433
Email
suhyunlee0811@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effects of Whole-body Vibration Exercise in Brain Injury Patients With Minimally Conscious State
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