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

History of Changes

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:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

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 (Adult, Senior)
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:

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

ClinicalTrials.gov processed this record on September 27, 2016

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