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 range

3 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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