An interventional study of MRI in Muscle Weakness and XLH, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown. Open to participants aged 5 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
XLH rickets is a rare disease with muscle weakness. Fat parameters such as IMAT and intraMAT could be increased in this disease. IMAT and intraMAT will be calculated on MRI for 11 XLH children versus 20 typically developing children. The investigator will compare the percentage of IMAT in the XLH group versus control group and the difference concerning the intraMAT between the two groups.
Single-center, prospective, non-randomized, controlled study with XLH and healthy volunteer children.
This study involves performing muscle MRI in healthy child volunteers to assess and compare the structure and composition of muscles to those of muscles in children with XLH pathology (muscle MRI of XLH patients is performed as part of standard medical care).
During this study we will have two groups: XLH group and a control group with typically developing children. In the XLH group, composed of 10 patients aged between 5 ans 17 years, female or male and ongoing growth (lesser bone age than 15 years old), have XLH and the most severe radiological deformities,clinical complications (pain and muscular weakness), have already done a muscle MRI of the lower limb during their follow-up.
The control group composed of 20 healthy volunteers aged between 5 ans 17 years old, female or male and without any endocrine pathology. A muscle MRI is necessary for healthy volunteers.
Every child will be alone After signing the informed consent by the 2 parents, the patient or the healthy volunteer and his parents, the MRI assessment will be performed on the same day.
Performing the muscle MRI requires the cooperation of the child in order to remain lying down and motionless throughout the duration of the MRI, i.e. approximately 45 minutes.
Performing MRI does not require the injection of contrast products or radiopharmaceuticals.
601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.
This study's planned enrollment of 30 is below the median of 46 across 444 interventional studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Inclusion Criteria common criteria to the 2 groups:
Inclusion criteria for XLH Patients :
incluion criteria for helthy volunteers :
Exclusion Criteria common to the 2 groups :
Exclusion criteria for Healthy volunteers :
Patient group composed of 10 patients aged between 5 to 17 years old, female or male, with X-linked hypophosphatemic (XLH) rickets, severity of clinical and radiological damage (pain, muscle weakness and severe bone deformities) and ongoing growth (lesser bone age than 15 years old), child under conventional treatment
Other: MRI
control group composed of 20 helthy volunteers aged between 5 to 17 years old, female or male, without any endocrine pathology, not suffering from XLH, matching by age (+/- 6 months) and sex
Other: MRI
Performing the muscle MRI requires the cooperation of the child in order to remain lying down and motionless throughout the duration of the MRI, about 45 minutes. Performing MRI does not require the injection of contrast products or radiopharmaceuticals.
Quantify and compare muscle composition in XLH children versus healthy control children to demonstrate a link between muscle function and muscle quality.
calculation of inter-muscular adipose tissue will be done in cm2
Time frame: 1 day
Measurement of muscle strength on force platforms, during gait analysis. Power test by mechanography of the jump (bipod and monopodal). Grasping test and correlation of fatty infiltration and functional data.
The Outcome Measure is BMI (Kg/m²)
Time frame: 1 day
Quantitative analysis of the muscles of the lower limbs (volume and length)
The Outcome Measure is BMI (Kg/m²)
Time frame: 1 day
No study locations are listed for this record.
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris