Effects of Whole Body Vibration in Subacute Stroke Patients

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00796237
• Other study ID #: UW-08-032
• Status: Recruiting
• Phase: N/A
• First received: November 21, 2008
• Last updated: August 8, 2011
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2011
• Source: The Hong Kong Polytechnic University
• Contact: Ricky WK Lau, MSc
• Phone: 85298743644
• Email: rsricky[@]inet.polyu.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

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.

Locations

Country	Name	City	State
Hong Kong	Tung Wah Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Tung Wah Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

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. — View Citation

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. — View 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. — View 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. Epub 2003 Dec 22. — View 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. Epub 2004 Jan 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of bone resorption marker CTx		baseline, immediately after treatment, and 2-month follow-up	No
Primary	Level of bone formation marker, BSAP		baseline, immediately after treatment, and 2-month follow-up	No
Secondary	Six minute walk test		baseline, immediately after treatment, and 2-month follow-up	No
Secondary	Ankle arm index		baseline, immediately after treatment, and 2-month follow-up	No
Secondary	Functional Ambulation category		baseline, immediately after treatment, and 2-month follow-up	No
Secondary	Leg muscle strength (hand-held dynamometry)		baseline, immediately after treatment, and 2-month follow-up	No
Secondary	Berg Balance Scale		baseline, immediately after treatment, and 2-month follow-up	No
Secondary	Modified Ashworth Scale of Spasticity		baseline, immediately after treatment, and 2-month follow-up	No
Secondary	Sensory threshold to light touch in the foot		baseline, immediately after treatment, and 2-month follow-up	No
Secondary	Fugl-Meyer Motor Assessment		baseline, immediately after treatment, and 2-month follow-up	No