Effects of Whole Body Vibration in Subacute Stroke Patients
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Whole body vibration therapy
standing on the vibration platform but no vibration will be applied
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, bone, gait, muscle, vibration, motor balance
Eligibility 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
Sites / Locations
- Tung Wah HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
WBV
CON
Arm Description
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.
The subjects in this group will not receive whole body vibration therapy.
Outcomes
Primary Outcome Measures
Level of bone resorption marker CTx
Level of bone formation marker, BSAP
Secondary Outcome Measures
Six minute walk test
Ankle arm index
Functional Ambulation category
Leg muscle strength (hand-held dynamometry)
Berg Balance Scale
Modified Ashworth Scale of Spasticity
Sensory threshold to light touch in the foot
Fugl-Meyer Motor Assessment
Full Information
NCT ID
NCT00796237
First Posted
November 21, 2008
Last Updated
August 8, 2011
Sponsor
The Hong Kong Polytechnic University
Collaborators
Tung Wah Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00796237
Brief Title
Effects of Whole Body Vibration in Subacute Stroke Patients
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 Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Tung Wah Hospital
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 turnover, physical fitness and neuromotor performance in patients with subacute stroke.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, bone, gait, muscle, vibration, motor balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WBV
Arm Type
Experimental
Arm Description
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.
Arm Title
CON
Arm Type
Active Comparator
Arm Description
The subjects in this group will not receive whole body vibration therapy.
Intervention Type
Device
Intervention Name(s)
Whole body vibration therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standing on the vibration platform but no vibration will be applied
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of bone resorption marker CTx
Time Frame
baseline, immediately after treatment, and 2-month follow-up
Title
Level of bone formation marker, BSAP
Time Frame
baseline, immediately after treatment, and 2-month follow-up
Secondary Outcome Measure Information:
Title
Six minute walk test
Time Frame
baseline, immediately after treatment, and 2-month follow-up
Title
Ankle arm index
Time Frame
baseline, immediately after treatment, and 2-month follow-up
Title
Functional Ambulation category
Time Frame
baseline, immediately after treatment, and 2-month follow-up
Title
Leg muscle strength (hand-held dynamometry)
Time Frame
baseline, immediately after treatment, and 2-month follow-up
Title
Berg Balance Scale
Time Frame
baseline, immediately after treatment, and 2-month follow-up
Title
Modified Ashworth Scale of Spasticity
Time Frame
baseline, immediately after treatment, and 2-month follow-up
Title
Sensory threshold to light touch in the foot
Time Frame
baseline, immediately after treatment, and 2-month follow-up
Title
Fugl-Meyer Motor Assessment
Time Frame
baseline, immediately after treatment, and 2-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricky WK Lau, MSc
Phone
85298743644
Email
rsricky@inet.polyu.edu.hk
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
Tung Wah Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonard SW Li, MD
Email
lswli@hkucc.hku.hk
First Name & Middle Initial & Last Name & Degree
Leonard SW Li, MD
First Name & Middle Initial & Last Name & Degree
Felix HF Chung, MSc
First Name & Middle Initial & Last Name & Degree
Ricky WK Lau, MSc
12. IPD Sharing Statement
Citations:
PubMed Identifier
17595419
Citation
Bogaerts A, Delecluse C, Claessens AL, Coudyzer W, Boonen S, Verschueren SM. Impact of whole-body vibration training versus fitness training on muscle strength and muscle mass in older men: a 1-year randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2007 Jun;62(6):630-5. doi: 10.1093/gerona/62.6.630.
Results Reference
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PubMed Identifier
15040822
Citation
Verschueren SM, Roelants M, Delecluse C, Swinnen S, Vanderschueren D, Boonen S. Effect of 6-month whole body vibration training on hip density, muscle strength, and postural control in postmenopausal women: a randomized controlled pilot study. J Bone Miner Res. 2004 Mar;19(3):352-9. doi: 10.1359/JBMR.0301245. Epub 2003 Dec 22.
Results Reference
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PubMed Identifier
15502741
Citation
van Nes IJ, Geurts AC, Hendricks HT, Duysens J. Short-term effects of whole-body vibration on postural control in unilateral chronic stroke patients: preliminary evidence. Am J Phys Med Rehabil. 2004 Nov;83(11):867-73. doi: 10.1097/01.phm.0000140801.23135.09.
Results Reference
background
PubMed Identifier
12733727
Citation
Torvinen S, Kannus P, Sievanen H, Jarvinen TA, Pasanen M, Kontulainen S, Nenonen A, Jarvinen TL, Paakkala T, Jarvinen M, Vuori I. Effect of 8-month vertical whole body vibration on bone, muscle performance, and body balance: a randomized controlled study. J Bone Miner Res. 2003 May;18(5):876-84. doi: 10.1359/jbmr.2003.18.5.876.
Results Reference
background
PubMed Identifier
15040823
Citation
Ward K, Alsop C, Caulton J, Rubin C, Adams J, Mughal Z. Low magnitude mechanical loading is osteogenic in children with disabling conditions. J Bone Miner Res. 2004 Mar;19(3):360-9. doi: 10.1359/JBMR.040129. Epub 2004 Jan 27.
Results Reference
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Effects of Whole Body Vibration in Subacute Stroke Patients
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