Clinical Trial

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

Study acronym: AID2GAIT
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Summary
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 a bilaterally symmetrical gait, as the individual actively tries to advance each limb during walking, combined with a patented dynamic body weight support system.
Trial Details
NCT Number NCT06947889
Lead Sponsor G. d'Annunzio University
Collaborators: Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio
Conditions Cerebral Palsy Infantile, Robotic Assisted Gait Training
Enrollment 11 participants
Start Date 2024-07-01
Primary Completion 2025-03-31 (estimated)
Study Completion 2026-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-04-27