Biofeedback system to improve robotic gait training for children with cerebral palsy
AID2GAIT: Biofeedback Based System to Enhance Robotic Assisted Gait Training in Children With Cerebral Palsy
This study is testing a new biofeedback system during robotic gait training to see if it can help children with cerebral palsy improve their walking skills.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 11 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | G. d'Annunzio University Academic / other |
| Locations | 1 site (San Giovanni Rotondo, FG) |
| Trial ID | NCT06947889 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 18 years with cerebral palsy who can express discomfort and understand simple instructions.
Not a fit: Patients with severe lower limb conditions, uncontrolled seizures, or other medical issues that interfere with training may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the rehabilitation outcomes for children with cerebral palsy undergoing gait training.
How similar studies have performed: While the integration of biofeedback in robotic gait training is a novel approach, similar studies have shown promise in enhancing rehabilitation outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Giovanni Rotondo, FG
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.