Effects of Whole Body Vibration in Subacute Stroke Patients

August 8, 2011 updated by: The Hong Kong Polytechnic University

Effects of Whole Body Vibration Training on Bone Health, Physical Fitness, and Neuromotor Performance in Individuals With Subacute Stroke: a Randomized Controlled Trial

The overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone turnover, physical fitness and neuromotor performance in patients with subacute stroke.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Brief periods of Whole body vibration (WBV) have been shown to improve bone density in post-menopausal women and children with cerebral palsy. In addition to the apparent benefits on bone health, WBV has been shown to increase muscle strength, postural control, muscular blood flow and oxygen uptake in various populations. Therefore, WBV can potentially be used as a tool to improve muscle strength, balance, and cardiovascular performance, especially for those with relatively low level of functioning. Stroke patients are therefore possible beneficiaries of WBV, as they often demonstrate muscle weakness, balance deficits, and poor cardiovascular function, in addition to bone loss. Only one pilot study has examined the effects of WBV in stroke patients. Van Nes et al.showed that postural stability in chronic stroke patients is improved after a few minutes of WBV at 30Hz and 3mm amplitude. The overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone turnover, physical fitness and neuromotor performance in patients with subacute stroke.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Tung Wah Hospital
        • Contact:
        • Principal Investigator:
          • Leonard SW Li, MD
        • Sub-Investigator:
          • Felix HF Chung, MSc
        • Sub-Investigator:
          • Ricky WK Lau, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • diagnosis of stroke
  • medically stable
  • able to understand simple verbal commands
  • of chinese origin

Exclusion Criteria:

  • previous stroke in addition to the current admission
  • other neurological conditions, in addition to stroke
  • significant musculoskeletal or vascular conditions in the lower extremity
  • metal implants in the lower extremity
  • previous fracture in the lower extremity
  • are taking or were taking bone resorption inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: WBV
In their regular physiotherapy sessions, the subjects in the experimental group will receive whole body vibration therapy for a duration of 4 weeks during their stay in the Tung Wah Hospital.
Device: Whole body vibration therapy
In their regular physiotherapy sessions, the subjects in the experimental group will receive WBV (20-240Hz, 10-minute sessions, 1 session per day, 5 sessions per week). The vibration loading will be carried out using the Fit-Vibe System (Germany), which is a vibration platform that is capable of generating vertical vibration.
ACTIVE_COMPARATOR: CON
The subjects in this group will not receive whole body vibration therapy.
Other: standing on the vibration platform but no vibration will be applied
The subjects in this group will perform the same exercises on the vibration platform as in the experimental group for the same duration, but no vibration will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of bone resorption marker CTx
Time Frame: baseline, immediately after treatment, and 2-month follow-up
baseline, immediately after treatment, and 2-month follow-up
Level of bone formation marker, BSAP
Time Frame: baseline, immediately after treatment, and 2-month follow-up
baseline, immediately after treatment, and 2-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Six minute walk test
Time Frame: baseline, immediately after treatment, and 2-month follow-up
baseline, immediately after treatment, and 2-month follow-up
Ankle arm index
Time Frame: baseline, immediately after treatment, and 2-month follow-up
baseline, immediately after treatment, and 2-month follow-up
Functional Ambulation category
Time Frame: baseline, immediately after treatment, and 2-month follow-up
baseline, immediately after treatment, and 2-month follow-up
Leg muscle strength (hand-held dynamometry)
Time Frame: baseline, immediately after treatment, and 2-month follow-up
baseline, immediately after treatment, and 2-month follow-up
Berg Balance Scale
Time Frame: baseline, immediately after treatment, and 2-month follow-up
baseline, immediately after treatment, and 2-month follow-up
Modified Ashworth Scale of Spasticity
Time Frame: baseline, immediately after treatment, and 2-month follow-up
baseline, immediately after treatment, and 2-month follow-up
Sensory threshold to light touch in the foot
Time Frame: baseline, immediately after treatment, and 2-month follow-up
baseline, immediately after treatment, and 2-month follow-up
Fugl-Meyer Motor Assessment
Time Frame: baseline, immediately after treatment, and 2-month follow-up
baseline, immediately after treatment, and 2-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Tung Wah Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

November 21, 2008

First Submitted That Met QC Criteria

November 21, 2008

First Posted (ESTIMATE)

November 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2011

Last Update Submitted That Met QC Criteria

August 8, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW-08-032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Whole body vibration therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe