Biofeedback system to improve robotic gait training for children with cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The AID2GAIT project focuses on enhancing robotic-assisted gait training (RAGT) for children with cerebral palsy by integrating a biofeedback system. This system utilizes non-invasive technologies to monitor physiological signals, including heart rate variability from smartwatches, facial temperature via infrared thermography, and brain activity through functional near-infrared spectroscopy (fNIRS). Over 12 sessions of RAGT using the Lokomat exoskeleton, data will be collected to assess the effectiveness of the training and the psychophysiological state of the participants. The goal is to improve motor skills and overall treatment outcomes through real-time data analysis and machine learning models.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio
  San Giovanni Rotondo, Fg, Italy Recruiting

Study contacts

• Principal investigator: Daniela Cardone, Dr — G. d'Annunzio University
• Study coordinator: Daniela Cardone, Dr
• Email: daniela.cardone@unich.it
• Phone: +39 085 453 7260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.