Effects of Whole Body Vibration in Subacute Stroke Patients

NCT00796237 | Unknown DMC

• 1 other identifier: UW-08-032
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; bone; gait; muscle; vibration; motor balance

Outcome Measures

Primary Outcomes (2)

• Level of bone resorption marker CTx

  baseline, immediately after treatment, and 2-month follow-up

• Level of bone formation marker, BSAP

  baseline, immediately after treatment, and 2-month follow-up

Secondary Outcomes (8)

• Six minute walk test

  baseline, immediately after treatment, and 2-month follow-up

• Ankle arm index

  baseline, immediately after treatment, and 2-month follow-up

• Functional Ambulation category

  baseline, immediately after treatment, and 2-month follow-up

• Leg muscle strength (hand-held dynamometry)

  baseline, immediately after treatment, and 2-month follow-up

• Berg Balance Scale

  baseline, immediately after treatment, and 2-month follow-up

Study Arms (2)

WBV

EXPERIMENTAL

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

CON

ACTIVE COMPARATOR

The subjects in this group will not receive whole body vibration therapy.

Other: standing on the vibration platform but no vibration will be applied

Interventions

Whole body vibration therapy DEVICE

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.

WBV

standing on the vibration platform but no vibration will be applied OTHER

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.

CON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of stroke
• medically stable
• able to understand simple verbal commands
• of chinese origin

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Tung Wah Hospital: collaborator

Study Sites (1)

Tung Wah Hospital

Hong Kong, Hong Kong

RECRUITING

Related 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. doi: 10.1093/gerona/62.6.630.

  PMID: 17595419 BACKGROUND

• 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.

  PMID: 15040822 BACKGROUND

• 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.

  PMID: 15502741 BACKGROUND

• 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.

  PMID: 12733727 BACKGROUND

• 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.

  PMID: 15040823 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Marco YC Pang, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricky WK Lau, MSc

CONTACT

85298743644; rsricky@inet.polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 9, 2011

Record last verified: 2011-08

Locations

HK (1)