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

NCT03389113 | Unknown

• 1 other identifier: 2016-04-101-004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries; Minimally Conscious State

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Coma Recovery Scale-Revised

  session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)

• Modified Ashworth scale

  session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)

Study Arms (2)

Whole body vibration group

EXPERIMENTAL

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.

Device: Whole body vibration; Other: Exersice

Exercise only group

ACTIVE COMPARATOR

The control group performed the same session without vibration.

Other: Exersice

Interventions

Whole body vibration DEVICE

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.

Whole body vibration group

Exersice OTHER

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

Exercise only group; Whole body vibration group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Persistent Vegetative State

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yun-Hee Kim, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-Hee Kim, MD, PhD

CONTACT

82-2-3410-2824; yunkim@skku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 3, 2018
• Study Start: January 2, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 20, 2019

Record last verified: 2017-12

Locations

KR (1)