Effect of Whole Body Vibration Therapy in Children With Juvenile Idiopathic Arthritis (WBV-JIA)
Primary Purpose
Juvenile Idiopathic Arthritis
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Galileo (whole body vibration (WBV) therapy)
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring arthritis, juvenile idiopathic arthritis, pediatric, intervention, vibration therapy, JIA
Eligibility 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
Sites / Locations
- Children's Hospital of Eastern Ontario
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control
Arm Description
Will undergo whole body vibration (WBV) therapy (6 minutes of training on 5 days a week for 3 months)
Will follow daily habitual activities
Outcomes
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.
Secondary Outcome Measures
The increase in muscle force measured during a one leg jump as determined by jumping mechanography
The increase in joint moment and power of the lower-limb measured in a gait lab using motion analysis
The change in range of motion, velocity and step distance during walking measured by motion analysis and on the Leonardo gangway
Muscle activation changes in amplitude and frequency content measured by surface EMG
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
Full Information
NCT ID
NCT00836394
First Posted
February 3, 2009
Last Updated
May 8, 2018
Sponsor
Children's Hospital of Eastern Ontario
Collaborators
Canadian Arthritis Network, University of Ottawa
1. Study Identification
Unique Protocol Identification Number
NCT00836394
Brief Title
Effect of Whole Body Vibration Therapy in Children With Juvenile Idiopathic Arthritis
Acronym
WBV-JIA
Official Title
The Effect of Whole Body Vibration Therapy on Muscle Function and Joint Loading in Children With Juvenile Idiopathic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No potential participants met entry criteria
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario
Collaborators
Canadian Arthritis Network, University of Ottawa
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
arthritis, juvenile idiopathic arthritis, pediatric, intervention, vibration therapy, JIA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Will undergo whole body vibration (WBV) therapy (6 minutes of training on 5 days a week for 3 months)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Will follow daily habitual activities
Intervention Type
Device
Intervention Name(s)
Galileo (whole body vibration (WBV) therapy)
Other Intervention Name(s)
Galileo
Intervention Description
6 minutes of training on 5 days a week for 3 months
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The increase in muscle force measured during a one leg jump as determined by jumping mechanography
Time Frame
12 weeks
Title
The increase in joint moment and power of the lower-limb measured in a gait lab using motion analysis
Time Frame
12 weeks
Title
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
Title
Muscle activation changes in amplitude and frequency content measured by surface EMG
Time Frame
12 weeks
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Roth, MD
Organizational Affiliation
Children's Hospital of Eastern Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K0C 1L0
Country
Canada
12. IPD Sharing Statement
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Effect of Whole Body Vibration Therapy in Children With Juvenile Idiopathic Arthritis
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