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Clinical Trials/NCT03375346
NCT03375346CompletedNot Applicable

Effects of Whole-body Vibration Exercise on Brain Activity and Physical Function in Hemiplegia Stroke Patients

Samsung Medical Center0 sites29 target enrollmentStarted: August 4, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
29
Primary Endpoint
Cerebral cortex activity

Study Overview

Brief Summary

The purpose of this study is to investigate the effect of the whole body vibration exercise on cortical activity and gait function in patients with chronic stroke.

Detailed Description

Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle strength and postural control in stroke patients. However, there has not yet been a report on the cortical activity changes induced by whole body vibration exercise.

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 assessments were performed before and after the intervention session using the 10-meter walk test, timed up and go test, Fugl-Meyer Assessment, and Tinetti Performance Oriented Mobility Assessment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
19 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Unilateral stroke with hemiplegia
  • 3 months after stroke onset
  • Able to walk at least 10 meters without assistive devices

Exclusion Criteria

  • Subjects under 18 years and above 80 years old,
  • Unable to perform a half squat on a vibrator (eg. visual field defects, fracture, and severe muscle paralysis)
  • Musculoskeletal disorders
  • Risk of falling due to dizziness
  • Pregnant women

Arms & Interventions

Whole body vibration group

Experimental

Whole body vibration group performed a single session 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.

Intervention: Whole body vibration (Device)

Whole body vibration group

Experimental

Whole body vibration group performed a single session 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.

Intervention: Exercise (Other)

Exercise only group

Active Comparator

The control group performed the same session without vibration.

Intervention: Exercise (Other)

Outcomes

Primary Outcomes

Cerebral cortex activity

Time Frame: check before, during and directly after intervention(for approximately 14 minutes)

cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS

Secondary Outcomes

  • 10 meter walk test(before and after intervention(Approximately 14 minutes))
  • Fugl-Meyer Assessment(before and after intervention(Approximately 14 minutes))
  • Timed up and go test(before and after intervention(Approximately 14 minutes))
  • Tinetti Performance Oriented Mobility Assessment(before and after intervention(Approximately 14 minutes))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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