Clinical trial NCT00796237: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
bone
gait
muscle
vibration
motor balance
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Tung Wah Hospital
First posted: 2008-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Level of bone resorption marker CTx
timeFrame: baseline, immediately after treatment, and 2-month follow-up
measure: Level of bone formation marker, BSAP
timeFrame: baseline, immediately after treatment, and 2-month follow-up
Secondary outcomes:
measure: Six minute walk test
timeFrame: baseline, immediately after treatment, and 2-month follow-up
measure: Ankle arm index
timeFrame: baseline, immediately after treatment, and 2-month follow-up
measure: Functional Ambulation category
timeFrame: baseline, immediately after treatment, and 2-month follow-up
measure: Leg muscle strength (hand-held dynamometry)
timeFrame: baseline, immediately after treatment, and 2-month follow-up
measure: Berg Balance Scale
timeFrame: baseline, immediately after treatment, and 2-month follow-up
measure: Modified Ashworth Scale of Spasticity
timeFrame: baseline, immediately after treatment, and 2-month follow-up
measure: Sensory threshold to light touch in the foot
timeFrame: baseline, immediately after treatment, and 2-month follow-up
measure: Fugl-Meyer Motor Assessment
timeFrame: baseline, immediately after treatment, and 2-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital
Study officials:
affiliation: Hong Kong Polytechnic University
name: Marco YC Pang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.