Effects of Whole Body Vibration in Subacute Stroke Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by The Hong Kong Polytechnic University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Tung Wah Hospital
Information provided by:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT00796237
First received: November 21, 2008
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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 Intervention
Stroke
Device: Whole body vibration therapy
Other: standing on the vibration platform but no vibration will be applied

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Level of bone resorption marker CTx [ Time Frame: baseline, immediately after treatment, and 2-month follow-up ] [ Designated as safety issue: No ]
  • Level of bone formation marker, BSAP [ Time Frame: baseline, immediately after treatment, and 2-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Six minute walk test [ Time Frame: baseline, immediately after treatment, and 2-month follow-up ] [ Designated as safety issue: No ]
  • Ankle arm index [ Time Frame: baseline, immediately after treatment, and 2-month follow-up ] [ Designated as safety issue: No ]
  • Functional Ambulation category [ Time Frame: baseline, immediately after treatment, and 2-month follow-up ] [ Designated as safety issue: No ]
  • Leg muscle strength (hand-held dynamometry) [ Time Frame: baseline, immediately after treatment, and 2-month follow-up ] [ Designated as safety issue: No ]
  • Berg Balance Scale [ Time Frame: baseline, immediately after treatment, and 2-month follow-up ] [ Designated as safety issue: No ]
  • Modified Ashworth Scale of Spasticity [ Time Frame: baseline, immediately after treatment, and 2-month follow-up ] [ Designated as safety issue: No ]
  • Sensory threshold to light touch in the foot [ Time Frame: baseline, immediately after treatment, and 2-month follow-up ] [ Designated as safety issue: No ]
  • Fugl-Meyer Motor Assessment [ Time Frame: baseline, immediately after treatment, and 2-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796237

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

Locations
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
Principal Investigator: Marco YC Pang, PhD Hong Kong Polytechnic University
  More Information

Publications:
Responsible Party: Marco Yiu-Chung Pang, Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT00796237     History of Changes
Other Study ID Numbers: UW-08-032
Study First Received: November 21, 2008
Last Updated: August 8, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The Hong Kong Polytechnic University:
stroke
bone
gait
muscle
vibration
motor balance

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 22, 2014