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

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Samsung Medical Center

Status

Unknown

Conditions

Brain Injuries
Minimally Conscious State

Treatments

Device: Whole body vibration
Other: Exersice

Study type

Interventional

Funder types

Other

Identifiers

NCT03389113
2016-04-101-004

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Whole body vibration group
Experimental group
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.
Treatment:
Other: Exersice
Device: Whole body vibration
Exercise only group
Active Comparator group
Description:
The control group performed the same session without vibration.
Treatment:
Other: Exersice

Trial contacts and locations

1

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Central trial contact

Yun-Hee Kim, MD, PhD

Data sourced from clinicaltrials.gov

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