Effects of Whole-body Vibration Exercise in Brain Injury Patients With Minimally Conscious State

Not Applicable

• Conditions: Minimally Conscious State; Brain Injuries
• Interventions: Other: Exersice; Device: Whole body vibration

• Registration Number: NCT03389113
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-02
• Status Verified: 2017-12
• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2018-01-03
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-20
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise only group	Exersice	The control group performed the same session without vibration.
Whole body vibration group	Whole body vibration	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.
Whole body vibration group	Exersice	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.

Primary Outcome Measures

Name	Time	Method
Cerebral cortex activity	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

Secondary Outcome Measures

Name	Time	Method
Coma Recovery Scale-Revised	session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)	assess patients with a disorder of consciousness, commonly coma; The CRS-R consists of 23 items, grouped into 6 sub-scales: 1. .Auditory; 2. Visual; 3. Motor; 4. Oromotor; 5. Communication; 6. 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	session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)	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; 1. 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; 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; 3. Considerable increase in muscle tone, passive movement difficult; 4. Affected part(s) rigid in flexion or extension

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of