RecruitingNCT06947889

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

AID2GAIT: Biofeedback Based System to Enhance Robotic Assisted Gait Training in Children With Cerebral Palsy

Sponsor

G. d'Annunzio University

Enrollment

11 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Cerebral Palsy Infantile Robotic Assisted Gait Training

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.

Eligibility

Min Age: 3 YearsMax Age: 18 Years

Inclusion Criteria1

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 Criteria8

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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