Effects of Whole-body Vibration Exercise on Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375346
• Other study ID #: 2015-07-092
• Status: Completed
• Phase: N/A
• First received: December 12, 2017
• Last updated: December 18, 2017
• Start date: August 4, 2015
• Est. completion date: August 3, 2017

Study information

• Verified date: December 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 3, 2017
• Est. primary completion date: August 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Device:
• Whole body vibration
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.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral cortex activity	cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS	check before, during and directly after intervention(for approximately 14 minutes)
Secondary	10 meter walk test	performance measure used to assess walking speed in metres per second over a short distance. It can be Blender3D NormalWalkCycle.gifemployed to determine functional mobility, gait, and vestibular function.	before and after intervention(Approximately 14 minutes)
Secondary	Timed up and go test	test for gait speed and gait balance	before and after intervention(Approximately 14 minutes)
Secondary	Fugl-Meyer Assessment	a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.	before and after intervention(Approximately 14 minutes)
Secondary	Tinetti Performance Oriented Mobility Assessment	Task-oriented outcome measure that assesses gait and balance ability; is composed of a 9-item gait portion (POMA-G) and 7-item balance portion (POMA-B)	before and after intervention(Approximately 14 minutes)