Clinical trial NCT03375346: Effects of Whole-body Vibration Exercise on Stroke Patients
Official title: Effects of Whole-body Vibration Exercise on Brain Activity and Physical Function in Hemiplegia Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegia
Keywords: Whole body vibration exercise
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 29
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 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. The control group performed the same session 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cerebral cortex activity
timeFrame: check before, during and directly after intervention(for approximately 14 minutes)
Secondary outcomes:
measure: 10 meter walk test
timeFrame: before and after intervention(Approximately 14 minutes)
measure: Timed up and go test
timeFrame: before and after intervention(Approximately 14 minutes)
measure: Fugl-Meyer Assessment
timeFrame: before and after intervention(Approximately 14 minutes)
measure: Tinetti Performance Oriented Mobility Assessment
timeFrame: before and after intervention(Approximately 14 minutes)
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: