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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorIRCCS Fondazione Stella Maris

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age

willing to sign inform content

Disqualifiers

bisphosphonates or bone diseases

Trial design

Design model

Parallel

Treatments tested in this trial

  • REMS: Radiofrequency Echographic Multi Spectrometry

    Diagnostic test

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Children with cerebral palsyExperimental treatment 1 intervention
Group B: Typically developing childrenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bone/Muscle Unit Health Assessment

We will achieve the aim 1 by the following evaluations: \- 25OHD changes evaluated as plasma levels of Vitamin D, intended as hypovitaminosis D 25OHD\<20 ng/ml

Time frame
at enrollment
2

Evaluation of bone mineral density as QUS

AD-SOS (amplitude-dependent speed of sound) expressed as standard deviation compared to normal (absolute number) and BTT (bone transmission time expressed in seconds)

Time frame
at enrollment
3

Evaluation of bone/muscle score at REMS

T score and Z score at REMS are index of bone fagility and are expressed as standard deviation difference compared to normal (absolute number, cut off \<2.5). Moreover a % of fragility risk is produced (cut-off \>10%)

Time frame
at enrollment

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Fondazione Stella Maris

Lead sponsor

University of Pisa

Collaborator

Azienda Ospedaliero, Universitaria Pisana

Collaborator

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