Biofeedback Based System to Enhance Robotic Assisted Gait Training in Children With Cerebral Palsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorG. d'Annunzio University
About this trial
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
Qualifiers
None
Disqualifiers
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;
Trial design
Treatments tested in this trial
- RAGT
Treatment groups
No treatment groups listed
Sponsors and collaborators
G. d'Annunzio University
Lead sponsor
Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio
Collaborator
Source ClinicalTrials.gov