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StrokeNCT00796237

Effects of Whole Body Vibration in Subacute Stroke Patients

A study testing Whole body vibration therapy and standing on the vibration platform but no vibration will be applied in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Whole body vibration therapy and standing on the vibration platform but no vibration will be applied
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteHong Kong
Study dates
May 2008to Dec 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ricky WK Lau, MSc contact

85298743644

rsricky@inet.polyu.edu.hk

Hong Kong1 site, 1 recruiting

  • Tung Wah Hospital

    Hong Kong

    Leonard SW Li, MD, lswli@hkucc.hku.hk

    Leonard SW Li, MD

    Recruiting

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Conditions
Stroke
Being tested
Whole body vibration therapy, standing on the vibration platform but no vibration will be applied
Keywords
stroke, bone, gait, muscle, vibration, motor balance
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole body vibration therapyDevice

    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.

  • standing on the vibration platform but no vibration will be appliedOther

    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.

Study groups in NCT00796237
Study groupRoleWhat they receive
WBVExperimentalIn 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.
Receives: Device: Whole body vibration therapy
CONActive comparatorThe subjects in this group will not receive whole body vibration therapy.
Receives: Other: standing on the vibration platform but no vibration will be applied

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Level of bone resorption marker CTx

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

  2. Level of bone formation marker, BSAP

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

Secondary outcomes (8)

  1. Six minute walk test

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

  2. Ankle arm index

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

  3. Functional Ambulation category

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

  4. Leg muscle strength (hand-held dynamometry)

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

  5. Berg Balance Scale

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

  6. Modified Ashworth Scale of Spasticity

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

  7. Sensory threshold to light touch in the foot

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

  8. Fugl-Meyer Motor Assessment

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionDec 2011 (estimated)
  4. Study completionDec 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00796237
Sponsor's protocol ID
UW-08-032
Status last verified
Aug 2011
First submitted
21 Nov 2008
Last updated
9 Aug 2011
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1093/gerona/62.6.630.

    PubMed 17595419

  • 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.

    PubMed 15040822

  • 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.

    PubMed 15502741

  • 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.

    PubMed 12733727

  • 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.

    PubMed 15040823

Questions about this trial

What is this clinical trial studying?

A study testing Whole body vibration therapy and standing on the vibration platform but no vibration will be applied in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ricky WK Lau, MSc (85298743644, rsricky@inet.polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of bone resorption marker CTx (time frame: baseline, immediately after treatment, and 2-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00796237, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011.

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