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Effects of Whole Body Vibration in People With Chronic Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Whole body vibration therapy
Exercise on the vibration platform with the device turned off
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring cerebrovascular accident, bone, muscle, vibration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a diagnosis of stroke more than 6 months
  • medically stable
  • able to understand verbal commands
  • Abbreviated mental test score 6 or above
  • age >18
  • able to stand with or without aids for at least 1.5 minutes

Exclusion Criteria:

  • neurological conditions other than stroke
  • significant musculoskeletal conditions (e.g. amputations)
  • metal implants in the lower extremity
  • previous fracture of the lower extremity
  • are currently taking bone resorption inhibitors or were taking the same before stroke.
  • significant peripheral vascular disease
  • vestibular disorders
  • pregnancy
  • Other serious illnesses that preclude the person from participating in the study

Sites / Locations

  • Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Whole body vibration

Arm Description

The control group will perform the same exercises on the vibration platform, as in the experimental group. However, the vibration device will be turned off during the exercises.

Subjects in the experimental group will undergo whole body vibration (1 session per day, 3 sessions per week) for 8 weeks. The vibration loading will be carried out using the Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea). The vibration protocol used in this study will be 30Hz. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2)deep squatting , (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The total duration of exposure of whole body vibration per session will be about 10 minutes.

Outcomes

Primary Outcome Measures

Paretic knee concentric muscle strength
Paretic knee concentric muscle strength
Paretic knee concentric muscle strength

Secondary Outcome Measures

Non-paretic concentric knee muscle strength
Non-paretic knee concentric muscle strength
Non-paretic knee concentric muscle strength
Paretic knee eccentric muscle strength
Paretic knee eccentric muscle strength
Paretic knee eccentric muscle strength
Non-paretic knee eccentric muscle strength
Non-paretic knee eccentric muscle strength
Non-paretic knee eccentric muscle strength
Paretic knee isometric muscle strength
Paretic knee isometric muscle strength
Paretic knee isometric muscle strength
Non-paretic knee isometric muscle strength
Non-paretic knee isometric muscle strength
Non-paretic knee isometric muscle strength
Limit of stability test
Limit of stability test
Limit of stability test
Berg balance test
Berg balance test
Berg balance test
Activities-specific Balance Confidence Scale
Activities-specific Balance Confidence Scale
Activities-specific Balance Confidence Scale
Six Minute Walk Test
Six Minute Walk Test
Six Minute Walk Test
Self-selected gait velocity
Self-selected gait velocity
Self-selected gait velocity
Bone formation marker level
Bone formation marker level
Bone resorption marker level
Bone formation marker level
Bone resorption marker level
Bone resorption marker level
fall rate
Knee spasticity
Knee spasticity
Knee spasticity
Ankle spasticity
Ankle spasticity
Ankle spasticity
Level of satisfaction

Full Information

First Posted
July 10, 2009
Last Updated
April 1, 2013
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT00937339
Brief Title
Effects of Whole Body Vibration in People With Chronic Stroke
Official Title
The Effects of Exercise and Whole Body Vibration Training on Bone Health, Physical Fitness, and Neuromotor Performance in Individuals With Chronic Stroke: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone health, physical fitness and neuromotor performance in patients with chronic stroke. Subjects in the experimental group will undergo whole body vibration therapy (1 session per day, 3 sessions per week) for 8 weeks. The vibration frequency used in this study will be 30Hz. The total duration of exposure to vibration for the experimental group will be 10 minutes. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2) deep squatting, (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The control exercise group, on the other hand, will perform the same exercise program on the platform, but no vibration will be given. The training will be conducted by a qualified personnel with physiotherapy background. The outcome measurement will be performed 4 times: (1) immediately before the commencement of intervention, (2) immediately after termination of treatment, (3) at 1 month after termination of treatment. Each subject will be evaluated for bone markers, leg muscle strength, balance, spasticity, and walking ability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
cerebrovascular accident, bone, muscle, vibration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will perform the same exercises on the vibration platform, as in the experimental group. However, the vibration device will be turned off during the exercises.
Arm Title
Whole body vibration
Arm Type
Experimental
Arm Description
Subjects in the experimental group will undergo whole body vibration (1 session per day, 3 sessions per week) for 8 weeks. The vibration loading will be carried out using the Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea). The vibration protocol used in this study will be 30Hz. While standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2)deep squatting , (3) side-to-side weight-shift, (4) Forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. The total duration of exposure of whole body vibration per session will be about 10 minutes.
Intervention Type
Device
Intervention Name(s)
Whole body vibration therapy
Other Intervention Name(s)
Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)
Intervention Description
Experimental group: One session per day, 3 sessions per week, for consecutive 8 weeks. The total duration of whole body vibration therapy will be about 10 minutes per session.
Intervention Type
Device
Intervention Name(s)
Exercise on the vibration platform with the device turned off
Other Intervention Name(s)
Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)
Intervention Description
Control group: One session per day, 3 sessions per week, for consecutive 8 weeks. The subjects will perform the same exercises on the vibration platform but no vibration will be applied.
Primary Outcome Measure Information:
Title
Paretic knee concentric muscle strength
Time Frame
pre-test (week 0)
Title
Paretic knee concentric muscle strength
Time Frame
Post-test (week 8)
Title
Paretic knee concentric muscle strength
Time Frame
Follow-up (week 12)
Secondary Outcome Measure Information:
Title
Non-paretic concentric knee muscle strength
Time Frame
Pre-test (week 0)
Title
Non-paretic knee concentric muscle strength
Time Frame
Post-test (week 8)
Title
Non-paretic knee concentric muscle strength
Time Frame
Follow-up (week 12)
Title
Paretic knee eccentric muscle strength
Time Frame
pre-test (week 0)
Title
Paretic knee eccentric muscle strength
Time Frame
Post-test (week 8)
Title
Paretic knee eccentric muscle strength
Time Frame
WFollow-up (week 12)
Title
Non-paretic knee eccentric muscle strength
Time Frame
Pre-test (week 0)
Title
Non-paretic knee eccentric muscle strength
Time Frame
Post-test (week 8)
Title
Non-paretic knee eccentric muscle strength
Time Frame
Follow-up (week 12)
Title
Paretic knee isometric muscle strength
Time Frame
Pre-test (week 0)
Title
Paretic knee isometric muscle strength
Time Frame
Post-test (week 8)
Title
Paretic knee isometric muscle strength
Time Frame
Follow-up (week 12)
Title
Non-paretic knee isometric muscle strength
Time Frame
Pre-test (week 0)
Title
Non-paretic knee isometric muscle strength
Time Frame
Post-test (week 8)
Title
Non-paretic knee isometric muscle strength
Time Frame
Follow-up (week 12)
Title
Limit of stability test
Time Frame
Pre-test (week 0)
Title
Limit of stability test
Time Frame
Post-test (week 8)
Title
Limit of stability test
Time Frame
Follow-up (week 12)
Title
Berg balance test
Time Frame
Pre-test (week 0)
Title
Berg balance test
Time Frame
Post-test (week 12)
Title
Berg balance test
Time Frame
Follow-up (week 12)
Title
Activities-specific Balance Confidence Scale
Time Frame
Pre-test (week 0)
Title
Activities-specific Balance Confidence Scale
Time Frame
Post-test (week 8)
Title
Activities-specific Balance Confidence Scale
Time Frame
Follow-up (week 12)
Title
Six Minute Walk Test
Time Frame
Pre-test (week 0)
Title
Six Minute Walk Test
Time Frame
Post-test (week 8)
Title
Six Minute Walk Test
Time Frame
Follow-up (week 12)
Title
Self-selected gait velocity
Time Frame
Pre-test (week 0)
Title
Self-selected gait velocity
Time Frame
post-test (week 8)
Title
Self-selected gait velocity
Time Frame
Follow-up (week 12)
Title
Bone formation marker level
Time Frame
pre-test (week 0)
Title
Bone formation marker level
Time Frame
Post-test (week 8)
Title
Bone resorption marker level
Time Frame
pre-test (week 0)
Title
Bone formation marker level
Time Frame
Follow-up (week 12)
Title
Bone resorption marker level
Time Frame
post-test (week 8)
Title
Bone resorption marker level
Time Frame
Follow-up (week 12)
Title
fall rate
Time Frame
6 months after termination of treatment
Title
Knee spasticity
Time Frame
Pre-test (week 0)
Title
Knee spasticity
Time Frame
Post-test (week 8)
Title
Knee spasticity
Time Frame
Follow-up (week 12)
Title
Ankle spasticity
Time Frame
Pre-test (week 0)
Title
Ankle spasticity
Time Frame
Post-test (week 8)
Title
Ankle spasticity
Time Frame
Follow-up (week 12)
Title
Level of satisfaction
Time Frame
Post-test (week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: a diagnosis of stroke more than 6 months medically stable able to understand verbal commands Abbreviated mental test score 6 or above age >18 able to stand with or without aids for at least 1.5 minutes Exclusion Criteria: neurological conditions other than stroke significant musculoskeletal conditions (e.g. amputations) metal implants in the lower extremity previous fracture of the lower extremity are currently taking bone resorption inhibitors or were taking the same before stroke. significant peripheral vascular disease vestibular disorders pregnancy Other serious illnesses that preclude the person from participating in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco YC Pang, PhD
Organizational Affiliation
Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Polytechnic University
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Effects of Whole Body Vibration in People With Chronic Stroke

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