Effects of Whole-body Vibration Exercise on Stroke Patients
Primary Purpose
Stroke, Hemiplegia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole body vibration
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Whole body vibration exercise
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Whole body vibration group
Exercise only group
Arm Description
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.
Outcomes
Primary Outcome Measures
Cerebral cortex activity
cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS
Secondary Outcome Measures
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.
Timed up and go test
test for gait speed and gait balance
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.
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)
Full Information
NCT ID
NCT03375346
First Posted
December 12, 2017
Last Updated
December 18, 2017
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03375346
Brief Title
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
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 4, 2015 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
August 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia
Keywords
Whole body vibration exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole body vibration group
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise only group
Arm Type
Active Comparator
Arm Description
The control group performed the same session without vibration.
Intervention Type
Device
Intervention Name(s)
Whole body vibration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees
Primary Outcome Measure Information:
Title
Cerebral cortex activity
Description
cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS
Time Frame
check before, during and directly after intervention(for approximately 14 minutes)
Secondary Outcome Measure Information:
Title
10 meter walk test
Description
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.
Time Frame
before and after intervention(Approximately 14 minutes)
Title
Timed up and go test
Description
test for gait speed and gait balance
Time Frame
before and after intervention(Approximately 14 minutes)
Title
Fugl-Meyer Assessment
Description
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.
Time Frame
before and after intervention(Approximately 14 minutes)
Title
Tinetti Performance Oriented Mobility Assessment
Description
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)
Time Frame
before and after intervention(Approximately 14 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Hee Kim, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Whole-body Vibration Exercise on Stroke Patients
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