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Effects of Whole Body Vibration in Subacute Stroke Patients

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ClinicalTrials.gov Identifier: NCT00796237
Recruitment Status : Unknown
Verified August 2011 by The Hong Kong Polytechnic University.
Recruitment status was:  Recruiting
First Posted : November 24, 2008
Last Update Posted : August 9, 2011
Sponsor:
Collaborator:
Tung Wah Hospital
Information provided by:
The Hong Kong Polytechnic University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Device: Whole body vibration therapy Other: standing on the vibration platform but no vibration will be applied Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Whole Body Vibration Training on Bone Health, Physical Fitness, and Neuromotor Performance in Individuals With Subacute Stroke: a Randomized Controlled Trial
Study Start Date : May 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Level of bone resorption marker CTx [ Time Frame: baseline, immediately after treatment, and 2-month follow-up ]
  2. Level of bone formation marker, BSAP [ Time Frame: baseline, immediately after treatment, and 2-month follow-up ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00796237


Contacts
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Contact: Ricky WK Lau, MSc 85298743644 rsricky@inet.polyu.edu.hk

Locations
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Hong Kong
Tung Wah Hospital Recruiting
Hong Kong, Hong Kong
Contact: Leonard SW Li, MD       lswli@hkucc.hku.hk   
Principal Investigator: Leonard SW Li, MD         
Sub-Investigator: Felix HF Chung, MSc         
Sub-Investigator: Ricky WK Lau, MSc         
Sponsors and Collaborators
The Hong Kong Polytechnic University
Tung Wah Hospital
Investigators
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Principal Investigator: Marco YC Pang, PhD Hong Kong Polytechnic University
More Information
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Publications:

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Responsible Party: Marco Yiu-Chung Pang, Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00796237    
Other Study ID Numbers: UW-08-032
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: August 2011
Keywords provided by The Hong Kong Polytechnic University:
stroke
bone
gait
 muscle
vibration
motor balance
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases