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Search / Trial NCT06884956

High-tech Rehabilitation Impact on Muscle MRI

Launched by IRCCS EUGENIO MEDEA · Mar 13, 2025

Trial Information

Current as of November 11, 2025

Enrolling by invitation

Keywords

Muscle Mri High Tech Motion Rehabilitation

ClinConnect Summary

This is an observational study aiming to learn how high-tech rehabilitation for the legs affects muscle tissue. About 30 people aged 8 and older who are starting lower-limb rehab with devices like the GRAIL or Lokomat will be followed. The researchers will use MRI scans before and after roughly 2–3 weeks of rehab to measure muscle size (volume), fat inside the muscles, and a movement test called GMFM. A secondary MRI measurement will look at the quality of muscle fibers. The goal is to identify MRI markers that reflect changes from the rehabilitation.

Eligibility is for people 8+ who are undergoing this type of rehab and can lie still for an MRI (about 30 minutes) and follow instructions. Exclusions include any MRI safety issues or metal near the thighs. The study is being conducted at IRCCS Eugenio Medea in Bosisio Parini, Italy, and is currently enrolling by invitation with about 30 participants planned. Results are not yet available, and this is not a drug or device trial; participation would involve MRI sessions and movement tests around the rehab period to help understand who benefits most from high-tech rehabilitation.

Gender

ALL

Eligibility criteria

  • 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

About Irccs Eugenio Medea

IRCCS Eugenio Medea is a leading clinical research institute based in Italy, dedicated to advancing pediatric healthcare through innovative research and evidence-based practices. As a recognized center of excellence, it focuses on multidisciplinary approaches to address complex health challenges in children and adolescents, particularly in the fields of neurodevelopmental disorders, mental health, and rehabilitation. The institute collaborates with national and international partners to conduct rigorous clinical trials, aiming to translate scientific discoveries into effective therapeutic interventions. Committed to enhancing patient outcomes, IRCCS Eugenio Medea prioritizes ethical standards and patient safety in all its research endeavors.

Locations

Bosisio Parini, Lc, Italy

Patients applied

0 patients applied

Trial Officials

Denis Peruzzo, PhD

Principal Investigator

Scientific Institute IRCCS Eugenio Medea

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported