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

Brain Injuries Clinical Trial

Official title:

Effects of Whole-body Vibration Exercise on Cortical Activity and Consciousness Level in Brain Injury Patients With Minimally Conscious State: Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03389113
• Other study ID #: 2016-04-101-004
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2017
• Source: Samsung Medical Center
• Contact: Yun-Hee Kim, MD, PhD
• Phone: 82-2-3410-2824
• Email: yunkim[@]skku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Minimally Conscious State
• Persistent Vegetative State
• Wounds and Injuries

Intervention

Device:
• Whole body vibration
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.

Other:
• Exersice
Exercise maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral cortex activity	Cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS	session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Secondary	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.	session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Secondary	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	session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)