Ignite Creation Date:
2024-05-05 @ 9:12 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00836394
Status:
WITHDRAWN
Last Update Posted:
2018-05-14
First Post:
2009-02-03
Brief Title:
Effect of Whole Body Vibration Therapy in Children With Juvenile Idiopathic Arthritis
Sponsor:
Childrens Hospital of Eastern Ontario
Organization:
Childrens Hospital of Eastern Ontario
Study Overview
Official Title:
The Effect of Whole Body Vibration Therapy on Muscle Function and Joint Loading in Children With Juvenile Idiopathic Arthritis
Status:
WITHDRAWN
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No potential participants met entry criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WBV-JIA
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 Childrens 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
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 Childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None