Effects of Whole Body Vibration in Subacute Stroke Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

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. Epub 2003 Dec 22.

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.

Torvinen S, Kannus P, Sievänen H, Järvinen TA, Pasanen M, Kontulainen S, Nenonen A, Järvinen TL, Paakkala T, Järvinen 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.

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. Epub 2004 Jan 27.

Responsible Party:	Marco Yiu-Chung Pang, Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:	NCT00796237 History of Changes
Other Study ID Numbers:	UW-08-032
First Posted:	November 24, 2008
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:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases	Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases