RecruitingNot Applicable

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

Italy11 participantsStarted 2024-07-01

Plain-language 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.

Who can participate

Age range3 Years – 18 Years

SexALL

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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

What they're measuring

Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by GMFM88 clinical scale

Timeframe: One month (4 weeks) from the beginning of the 1st RAGT (T0)

Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by MAS clinical scale

Timeframe: One month (4 weeks) from the beginning of the 1st RAGT (T0)

Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by WeeFIM clinical scale

Timeframe: One month (4 weeks) from the beginning of the 1st RAGT (T0)

Analysis of variations in the motor skills of patients from T0 (1st RAGT) to T2 (12th RAGT), assessed by PEDSQL clinical scale

Timeframe: One month (4 weeks) from the beginning of the 1st RAGT (T0)

Measurement of heart rate variability of patients

Timeframe: Two years from the beginning

Measurement of fNIRS of patients

Timeframe: Two years from the beginning

Measurement of infrared imaging of patients

Timeframe: Two years from the beginning

Trial details

NCT IDNCT06947889

SponsorG. d'Annunzio University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-31

Contact for this trial

Daniela Cardone, Dr

+39 085 453 7260 daniela.cardone@unich.it

View on ClinicalTrials.gov More Cerebral Palsy Infantile trials