NCT00836394

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

February 3, 2009

Last Update Submit

May 8, 2018

Conditions

Juvenile Idiopathic Arthritis

Keywords

arthritisjuvenile idiopathic arthritispediatricinterventionvibration therapyJIA

Outcome Measures

Primary Outcomes (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.

    12 weeks

Secondary Outcomes (5)

  • The increase in muscle force measured during a one leg jump as determined by jumping mechanography

    12 weeks

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

    12 weeks

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

    12 weeks

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

    12 weeks

  • 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

    12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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)

Control

NO INTERVENTION

Will follow daily habitual activities

Interventions

Galileo (whole body vibration (WBV) therapy)DEVICE

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

Also known as: Galileo
Intervention Group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K0C 1L0, Canada

Location

MeSH Terms

Conditions

Arthritis, JuvenileArthritis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Johannes Roth, MD

    Children's Hospital of Eastern Ontario

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations

CA(1)