Status:
RECRUITING
Biofeedback Based System to Enhance Robotic Assisted Gait Training in Children With Cerebral Palsy
Lead Sponsor:
G. d'Annunzio University
Collaborating Sponsors:
Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio
Conditions:
Cerebral Palsy Infantile
Robotic Assisted Gait Training
Eligibility:
All Genders
3-18 years
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 sig...
Detailed Description
The entire RAGT treatment will consist of 12 sessions of robotic gait rehabilitation administered over 4 weeks. The protocol consists of a block paradigm: children will be asked to actively move duri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06947889
Start Date
July 1 2024
End Date
February 28 2026
Last Update
April 27 2025
Active Locations (1)
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1
Fondazione Centri di Riabilitazione Padre Pio Onlus - Gli Angeli di Padre Pio
San Giovanni Rotondo, FG, Italy, 71013