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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
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Whole body vibration exercise

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 12, 2017
    Last Updated
    December 18, 2017
    Sponsor
    Samsung Medical Center
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    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

    Learn more about this trial

    Effects of Whole-body Vibration Exercise on Stroke Patients

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