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BIOchemical, DEnsitometric, TEChnological and Imaging Tools to Evaluate the Bone/muscle in Children with Cerebral Palsy

NCT06672731 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-04

No results posted yet for this study

Summary

Cerebral palsy (CP) is the most common chronic disability in childhood, burden by motor, sensation, cognition, feeding and communication impairment. A serious concern in children with CP is bone/muscle health deterioration, which negatively impacts the already reduced quality of life (QoL). Children with CP show low bone density, vitamin D deficiency, sarcopenia and high risk of fragility fractures, with heavy effects on what is already limited home, school and community life. The causes for muscle-bone impairment are low weight-bearing deambulation during skeletal formation with low bone mineralization, poor nutrition and low calcium intake, low sun exposure, use of anticonvulsant medications with a negative profile on bone. Understanding the causes affecting bone quality and setting up interventions to reduce the impact of physical disability are essential in young subjects with CP.

This project combines complementary expertise and resources in the fields of Endocrinological Biochemistry, Paediatric Neurological Disorders and Neuroimaging, to allow an innovative, technology-assisted workup for bone/muscle health evaluation in young subjects with CP, which could drive novel therapeutics, nutritional and rehabilitation programs.

The first aim of this project is to evaluate bone/muscle health in young subjects with CP compared with sex-age matched healthy subjects, providing i) serum biomarkers of mineral metabolism and the metabolome of Vitamin D, assessed with last generation Mass Spectrometry, ii) muscle sarcopenia markers like Irisin and other myokines, depicting the response of the muscle to exercise iii) neuronal damage and inflammatory markers, iv) densitometric data by the low-cost and safe Quantitative ultrasound (QUS) at phalanges of the hand, plus the novel and very promising Radiofrequency Echographic Multi Spectrometry (REMS) served by the software for fragility fractures risk.

We also aim to correlate the previous mentioned markers of bone/muscle health with a combination of demographic, clinical, cognitive and technological parameters, the last obtained by an innovative use of wearable sensors or actigraphs, positioned at the wrists, which depicts movements, physical activity (PA), energy expenditures (EE) and, together with heart-rate monitors, metabolic data during a normal like week in subjects with CP and healthy controls. Finally, a newly validated scoring for brain lesions in subjects with CP and the production of imaging "biomarkers" of neuronal damage, will be correlated with their bone/muscle health data, PA and EE to understand the impact of brain damage on functional performance and bone metabolism.

Conditions

  • Cerebral Palsy Infantile

Interventions

DIAGNOSTIC_TEST

REMS: Radiofrequency Echographic Multi Spectrometry

it is a non invasive ultrasonographic evaluation of bone and muscle quality

Sponsors & Collaborators

  • University of Pisa

    collaborator OTHER

  • Azienda Ospedaliero, Universitaria Pisana

    collaborator OTHER

  • IRCCS Fondazione Stella Maris

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-05-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672731 on ClinicalTrials.gov