NCT06947889 Biofeedback Based System to Enhance Robotic Assisted Gait Training in Children With Cerebral Palsy
| NCT ID | NCT06947889 |
| Status | Recruiting |
| Phase | — |
| Sponsor | G. d'Annunzio University |
| Condition | Cerebral Palsy Infantile |
| Study Type | OBSERVATIONAL |
| Enrollment | 11 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 11 participants in total. It began in 2024-07-01 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Daniela Cardone, Dr
PRINCIPAL INVESTIGATOR
G. d'Annunzio University
Frequently Asked Questions
Who can join the NCT06947889 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Cerebral Palsy Infantile. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06947889 currently recruiting?
Yes, NCT06947889 is actively recruiting participants. Contact the research team at daniela.cardone@unich.it for enrollment information.
Where is the NCT06947889 trial being conducted?
This trial is being conducted at San Giovanni Rotondo, Italy.
Who is sponsoring the NCT06947889 clinical trial?
NCT06947889 is sponsored by G. d'Annunzio University. The principal investigator is Daniela Cardone, Dr at G. d'Annunzio University. The trial plans to enroll 11 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.