Clinical trial NCT03389113: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Injuries
Minimally Conscious State
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cerebral cortex activity
timeFrame: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Secondary outcomes:
measure: Coma Recovery Scale-Revised
timeFrame: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
measure: Modified Ashworth scale
timeFrame: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: