Effects of Whole Body Vibration in People With Chronic Stroke

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.

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Exercise on the vibration platform with the device turned off; Device: Whole body vibration therapy

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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.	Device: Exercise on the vibration platform with the device turned off; 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.; Other Names: Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)
Experimental: Whole body vibration; 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.	Device: Whole body vibration therapy; 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.; Other Names: Jet-Vibe System (Danil SMC Co., Ltd., Seoul, Korea)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Paretic knee concentric muscle strength	pre-test (week 0)
Paretic knee concentric muscle strength	Post-test (week 8)
Paretic knee concentric muscle strength	Follow-up (week 12)

Secondary Outcome Measures

Outcome Measure	Time Frame
Non-paretic concentric knee muscle strength	Pre-test (week 0)
Non-paretic knee concentric muscle strength	Post-test (week 8)
Non-paretic knee concentric muscle strength	Follow-up (week 12)
Paretic knee eccentric muscle strength	pre-test (week 0)
Paretic knee eccentric muscle strength	Post-test (week 8)
Paretic knee eccentric muscle strength	WFollow-up (week 12)
Non-paretic knee eccentric muscle strength	Pre-test (week 0)
Non-paretic knee eccentric muscle strength	Post-test (week 8)
Non-paretic knee eccentric muscle strength	Follow-up (week 12)
Paretic knee isometric muscle strength	Pre-test (week 0)
Paretic knee isometric muscle strength	Post-test (week 8)
Paretic knee isometric muscle strength	Follow-up (week 12)
Non-paretic knee isometric muscle strength	Pre-test (week 0)
Non-paretic knee isometric muscle strength	Post-test (week 8)
Non-paretic knee isometric muscle strength	Follow-up (week 12)
Limit of stability test	Pre-test (week 0)
Limit of stability test	Post-test (week 8)
Limit of stability test	Follow-up (week 12)
Berg balance test	Pre-test (week 0)
Berg balance test	Post-test (week 12)
Berg balance test	Follow-up (week 12)
Activities-specific Balance Confidence Scale	Pre-test (week 0)
Activities-specific Balance Confidence Scale	Post-test (week 8)
Activities-specific Balance Confidence Scale	Follow-up (week 12)
Six Minute Walk Test	Pre-test (week 0)
Six Minute Walk Test	Post-test (week 8)
Six Minute Walk Test	Follow-up (week 12)
Self-selected gait velocity	Pre-test (week 0)
Self-selected gait velocity	post-test (week 8)
Self-selected gait velocity	Follow-up (week 12)
Bone formation marker level	pre-test (week 0)
Bone formation marker level	Post-test (week 8)
Bone resorption marker level	pre-test (week 0)
Bone formation marker level	Follow-up (week 12)
Bone resorption marker level	post-test (week 8)
Bone resorption marker level	Follow-up (week 12)
fall rate	6 months after termination of treatment
Knee spasticity	Pre-test (week 0)
Knee spasticity	Post-test (week 8)
Knee spasticity	Follow-up (week 12)
Ankle spasticity	Pre-test (week 0)
Ankle spasticity	Post-test (week 8)
Ankle spasticity	Follow-up (week 12)
Level of satisfaction	Post-test (week 8)

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: April 1, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: muscle; bone; cerebrovascular accident; vibration
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HSEARS20090520002-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No