Actively Recruiting

Age: 3Years - 18Years
All Genders
NCT06947889

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

Led by G. d'Annunzio University · Updated on 2025-04-27

11

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

Sponsors

G

G. d'Annunzio University

Lead Sponsor

F

Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with cerebral palsy aged 3 to 18 years
  • GMFCS level from I to V
  • Ability to express discomfort or pain
  • Ability to understand simple instructions
Not Eligible

You will not qualify if you...

  • Medical problems interfering with training or restrictions on robotic device use
  • Severe lower limb conditions such as muscle contractures or hip instability/subluxation
  • Recent botulinum toxin A injections to lower limbs
  • Uncontrolled seizures
  • Open skin or vascular disorders of the lower limbs
  • Contraindications to Lokomat gait rehabilitation (weight under 10 kg, non-healed fractures, cognitive deficits limiting communication)
  • Fixed joint contractures limiting orthosis range of motion
  • Inability to properly adjust harness or orthoses

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio

San Giovanni Rotondo, FG, Italy, 71013

Actively Recruiting

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Research Team

D

Daniela Cardone, Dr

CONTACT

T

Teresa Paolucci, Prof.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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