Effect of Whole Body Vibration Therapy in Children With Juvenile Idiopathic Arthritis (WBV-JIA)

This study has been completed.
Sponsor:
Collaborators:
Canadian Arthritis Network
University of Ottawa
Information provided by:
Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT00836394
First received: February 3, 2009
Last updated: June 27, 2011
Last verified: May 2009
  Purpose

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.


Condition Intervention
Juvenile Idiopathic Arthritis
Device: Galileo (whole body vibration (WBV) therapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Whole Body Vibration Therapy on Muscle Function and Joint Loading in Children With Juvenile Idiopathic Arthritis

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The increase in muscle force measured during a one leg jump as determined by jumping mechanography [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The increase in joint moment and power of the lower-limb measured in a gait lab using motion analysis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The change in range of motion, velocity and step distance during walking measured by motion analysis and on the Leonardo gangway [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Muscle activation changes in amplitude and frequency content measured by surface EMG [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: February 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
Will undergo whole body vibration (WBV) therapy (6 minutes of training on 5 days a week for 3 months)
Device: Galileo (whole body vibration (WBV) therapy)
6 minutes of training on 5 days a week for 3 months
Other Name: Galileo
No Intervention: Control
Will follow daily habitual activities

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.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Lower-limb arthritis on clinical examination or MRI
  • Acute venous thrombosis
  • Acute hernia
  • Migraine
  • Epilepsy
  • Pregnancy
  • Participation in another interventional study
  • Surgery and/or fracture within previous 3 months
  • Joint replacements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836394

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K0C 1L0
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Canadian Arthritis Network
University of Ottawa
Investigators
Principal Investigator: Johannes Roth, MD Children's Hospital of Eastern Ontario
  More Information

No publications provided

Responsible Party: Johannes Roth, MD, Children's Hospital of Eastern Ontario - Department of Pediatric Rheumatology
ClinicalTrials.gov Identifier: NCT00836394     History of Changes
Other Study ID Numbers: WBV-JIA
Study First Received: February 3, 2009
Last Updated: June 27, 2011
Health Authority: Canada: Health Canada

Keywords provided by Children's Hospital of Eastern Ontario:
arthritis
juvenile idiopathic arthritis
pediatric
intervention
vibration therapy
JIA

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 29, 2014