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Enrolling by invitation Observational

High-tech Rehabilitation Impact on Muscle MRI

NCT06884956 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-06-13
Last updated
2025-03-19

Condition(s) studied

Movement DisordersTreatment

Study summary

The use of high-tech techniques is becoming increasingly popular in the rehabilitation field, where the use of exoskeletons, robots, virtual reality, etc. allow for customized rehabilitation protocols. Moreover, their combination with virtual reality systems improves the patient's involvement increasing the effectiveness of the treatment, especially in the pediatric context.

Several literature studies confirmed the effectiveness of rehabilitation treatments in the pediatric field in terms of functional and physiologic scores (e.g. GMFM).

This study aims to use MRI to identify biomarkers for the morpho-functional characterization of skeletal muscle and for the evaluation of the effect of high-tech rehabilitation treatment on it.

Eligibility

Sex
ALL
Min age
8 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * patients undergoing high-tech rehabilitation treatment of the lower limb * able to remain in a supine position for 30 minutes without moving * able to follow instructions and communicate effectively with operators (e.g communicating fear and/or pain) Exclusion Criteria: * any contraindication to MRI examination * presence of metal nails/protheses or objects near the thighs which will disrupt and/or induce distortion on the MR images

Primary outcome measure(s)

  • Volume — Evaluated before and after the (2-3 weeks) rehabilitation treatment. The MRI data were acquired within 3 days before the beginning of the treatment and the within one week after the end of the treatment.
    Muscular fibre volume derived from T1W MR images
  • Fat Fraction — Evaluated before and after the (2-3 weeks) rehabilitation treatment. The MRI data were acquired within 3 days before the beginning of the treatment and the within one week after the end of the treatment.
    Measure of fat infiltration in the muscular tissue derived from DIXON MR images and quantified in the different fiber bundles
  • GMFM — Evaluated before and after the (2-3 weeks) rehabilitation treatment. The GMFM scales will be administered close to the MRI scan sessions.
    Gross Motor Function Scale

Trial sites (1)

FacilityCityRegionStatus
IRCCS Eugenio Medea - La Nostra Famiglia Bosisio Parini LC

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06884956 on ClinicalTrials.gov ↗ ← All trials in Italy