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Biofeedback Based System to Enhance Robotic Assisted Gait Training in Children With Cerebral Palsy

Recruitingn/aAges 3 Years - 18 YearsAllG. d'Annunzio University
NCT06947889 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The AID2GAIT project aims to develop a biofeedback system with the aim of improving the outcomes of robot-assisted gait training (RAGT) in pediatric patients with cerebral palsy. The physiological signals of children during RAGT therapy sessions, acquired through non-invasive technologies, will be analyzed. These technologies specifically are: * wearable technology (smartwatch), from which the HRV (Heart Rate Variability) signal will be measured; * infrared thermography, from which the temperature in salient facial regions will be obtained; * fNIRS (functional near-infrared spectroscopy), from which information on brain activity and its changes over time will be obtained. Information on the kinematics of the exoskeleton used during RAGT will be extracted. The RAGT will be performed using the Lokomat orthosis (Hocoma), the most widely used exoskeleton in rehabilitation that facilitates

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📋 Eligibility rules (as published)
Inclusion Criteria: Children with cerebral palsy aged 3 to 18 years who have a GMFCS level from I to V, with the ability to express discomfort or pain and understanding simple instructions Exclusion Criteria: * Medical problems that could interfere with training and restrictions on the use of the robotic device; * severe lower limb conditions: muscle contractures, instability or subluxation of the hip; * recent botulinum toxin A injections to the lower limbs; * uncontrolled seizures; * open skin disorders and vascular disorders of the lower limbs. * Contraindications to gait rehabilitation treatment with Lokomat (e.g. weight \<10 kg, non-consolidated fractures, cognitive deficits limiting communication). * Contractures of fixed joints that limit the range of motion of the orthoses * Inability to properly adjust the harness and/or orthoses
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What it tests

  • RAGT
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Where

1 site
Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio
San Giovanni Rotondo, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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