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Juvenile Idiopathic ArthritisWBV-JIANCT00836394

Effect of Whole Body Vibration Therapy in Children With Juvenile Idiopathic Arthritis

A study testing Galileo (whole body vibration (WBV) therapy) in people with Juvenile Idiopathic Arthritis, run by Children's Hospital of Eastern Ontario at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Juvenile idiopathic arthritis (JIA) is one of the most common chronic illnesses in children, with recent data suggesting that 1 to 4 in 1000 Canadian children and youth cope with the condition. Many JIA children will enter adulthood with permanent joint damage5. Read more about this study

Who is it for?
Ages 7 to 18 years
Conditions the study is for
Juvenile Idiopathic Arthritis
What is being tested?
Galileo (whole body vibration (WBV) therapy)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
Feb 2009to Jan 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 7 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosis of JIA
  • No active lower-limb arthritis at recruitment shown by clinical examination or MRI
  • No active arthritis in the 3 months prior to study entry
  • Age > 7 years and < 18 years
  • Written informed consent from parents and patients over 14 years of age, assent from children 7 to 14 years
  • Written commitment by parents to supervise each therapy session
  • Z-score power ≤ -1 as determined on the Leonardo force plate

Who cannot join

  • Lower-limb arthritis on clinical examination or MRI
  • Acute venous thrombosis
  • Acute hernia
  • Migraine
  • Epilepsy
  • Pregnancy
Show all 9Show fewer
  • Participation in another interventional study
  • Surgery and/or fracture within previous 3 months
  • Joint replacements

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K0C 1L0

Other trials in Canada

About this study

Official title: The Effect of Whole Body Vibration Therapy on Muscle Function and Joint Loading in Children With Juvenile Idiopathic Arthritis

Juvenile idiopathic arthritis (JIA) is one of the most common chronic illnesses in children, with recent data suggesting that 1 to 4 in 1000 Canadian children and youth cope with the condition. Many JIA children will enter adulthood with permanent joint damage5. In parallel, a significant number are affected by deficits of muscle function. In addition to the impact on physical function, muscles play an important role in maintaining joint health. The overall aim of this proposal is to evaluate a novel therapeutic intervention - whole body vibration (WBV) - for its ability to improve muscle function and the biomechanics of lower extremity joints in JIA in order to prevent joint degeneration.

Read the detailed description

This project aims to evaluate the effect of a therapy called whole body vibration (WBV) on muscle function and joint biomechanics in children and adolescents suffering from juvenile idiopathic arthritis (JIA).

JIA is the most common chronic form of arthritis in children and affects at least 1 in 1000 Canadian children and youth. Current data suggests that a large number of children suffering from JIA will encounter permanent joint damage, to which direct effects of inflammation are an important contributor. Nevertheless, recent research has also shown that impaired muscle function and a subsequent alteration of joint loading might by itself induce joint damage. Fifty percent of JIA patients have significant impairments of muscle function and this is often present in patients who do not have active arthritis anymore. In addition to optimum medical treatment of the disease, it is therefore important to improve muscle function in order to protect the joints.

WBV therapy might be an interesting technique to achieve this in JIA patients. It is able to improve muscle function very efficiently with relatively short training times and at the same time confers loads to the lower limbs which are only 30% of body weight. The WBV device consists of a plate going up and down along a fulcrum at a high frequency. The patient stands on the WBV device and the vibration will induce muscle stretch reflexes producing muscle contractions. These muscle contractions are similar to muscle activity during exercise and are not perceived as painful or unpleasant. The technique has been used in children with several conditions impairing muscle function.

The primary question to be investigated in the proposed study is whether WBV therapy will significantly improve muscle function in JIA patients. In addition, the effect of an improvement in muscle function on gait and the loading of individual joints at the lower extremity will be examined. Finally the effect of WBV therapy on quality of life will be assessed.

We propose conducting a controlled trial investigation. This implies, that one group of study participants, called the intervention group, will do the WBV therapy, whereas a second group, called the control group, will just follow their daily habitual activities. All participants will have an initial assessment of muscle function, electrical muscle activity and joint biomechanics by completely painless measurement techniques at the Children's Hospital of Eastern Ontario (CHEO) and a nearby Human Motion Biomechanics lab at the University of Ottawa. In addition, an MRI of the lower legs without contrast media will be done to confirm the absence of joint effusions as well as bone or muscle edema. Quality of life will be assessed by a standard questionnaire that has been validated in JIA. Subsequently, study participants in the intervention group as well as their parents will be introduced to the therapy during two separate sessions at the CHEO. They will then take a WBV device home and perform 6 minutes of training on 5 days a week for 3 months. Each month, they will return to CHEO for assessment of muscle function and demonstration of training technique. At the end of the 3 month period, both intervention and control group patients will repeat the initial set of assessments including MRI. After another 3 month period, all participants will return for a final assessment of muscle function and joint biomechanics but not MRI to document persistence of any change observed.

Being tested
Galileo (whole body vibration (WBV) therapy)
Keywords
arthritis, juvenile idiopathic arthritis, pediatric, intervention, vibration therapy, JIA
Medical subject headings
Arthritis, Juvenile, Arthritis

What participants receive

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

  • Galileo (whole body vibration (WBV) therapy)Device

    Also called Galileo

    6 minutes of training on 5 days a week for 3 months

Study groups in NCT00836394
Study groupRoleWhat they receive
Intervention GroupExperimentalWill undergo whole body vibration (WBV) therapy (6 minutes of training on 5 days a week for 3 months)
Receives: Device: Galileo (whole body vibration (WBV) therapy)
ControlNo interventionWill follow daily habitual activities

What is being measured

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

  1. The primary objective is to evaluate the effect of whole body vibration therapy on muscle function by measuring the increase in z-score muscle power during a two leg jump as determined by jumping mechanography after 12 weeks compared to baseline.

    Measured: 12 weeks

Secondary outcomes (5)
  1. The increase in muscle force measured during a one leg jump as determined by jumping mechanography

    Measured: 12 weeks

  2. The increase in joint moment and power of the lower-limb measured in a gait lab using motion analysis

    Measured: 12 weeks

  3. The change in range of motion, velocity and step distance during walking measured by motion analysis and on the Leonardo gangway

    Measured: 12 weeks

  4. Muscle activation changes in amplitude and frequency content measured by surface EMG

    Measured: 12 weeks

  5. The safety of the therapy by documenting any recurrence of joint effusions, bone marrow or muscle edema as determined by MRI imaging of the lower extremity

    Measured: 12 weeks

Timeline

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

  1. First posted4 Feb 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionJan 2011
  4. Study completionJan 2011

Why it stopped: No potential participants met entry criteria

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00836394
Sponsor's protocol ID
WBV-JIA
Acronym
WBV-JIA
Status last verified
May 2018
First submitted
3 Feb 2009
Last updated
14 May 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Galileo (whole body vibration (WBV) therapy) in people with Juvenile Idiopathic Arthritis, run by Children's Hospital of Eastern Ontario at 1 site in Canada.

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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 14 May 2018. 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 Canada. 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective is to evaluate the effect of whole body vibration therapy on muscle function by measuring the increase in z-score muscle power during a two leg jump as determined by jumping mechanography after 12 weeks compared to baseline. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 May 2018.

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