ClinConnect ClinConnect Logo
Search / Trial NCT06947889

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

Launched by G. D'ANNUNZIO UNIVERSITY · Apr 24, 2025

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

Robotic Assisted Gait Training Biofeedback Infant Cerebral Palsy Human Robot Interaction Exoskeleton

ClinConnect Summary

The AID2GAIT clinical trial is studying a new system that uses biofeedback to improve robotic-assisted gait training for children with cerebral palsy. The goal is to help these children walk better by using advanced technologies that measure how their body reacts during therapy. This includes using a smartwatch to check their heart rate, special cameras to see changes in temperature on their face, and a device that looks at their brain activity. The children will use a robotic exoskeleton called the Lokomat, which helps them practice walking in a safe and supportive way.

To participate in this trial, children aged 3 to 18 with cerebral palsy are eligible if they can communicate any discomfort and understand simple instructions. However, those with certain medical issues or severe leg conditions may not qualify. If enrolled, participants can expect to engage in regular training sessions, where their progress will be closely monitored to enhance their walking abilities. This is a great opportunity for children with cerebral palsy to receive innovative therapy that could lead to better mobility.

Gender

ALL

Eligibility criteria

  • 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

About G. D'annunzio University

G. D'Annunzio University, located in Chieti-Pescara, Italy, is a prominent academic institution committed to advancing scientific research and innovation in the health sciences. With a strong emphasis on interdisciplinary collaboration, the university fosters an environment that encourages the development of novel therapeutic strategies and clinical applications. As a clinical trial sponsor, G. D'Annunzio University seeks to contribute to the improvement of patient outcomes through rigorous research methodologies, ethical standards, and a focus on translational medicine. Their dedication to education and research excellence positions them as a key player in the advancement of healthcare solutions.

Locations

San Giovanni Rotondo, Fg, Italy

Patients applied

0 patients applied

Trial Officials

Daniela Cardone, Dr

Principal Investigator

G. d'Annunzio University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported