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Robot Asissted Training on Neurodevelopmental Alterations

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A vizsgálat adatai

Ki végzi
University of Valencia
Azonosító
NCT06645795
A regiszteradat frissítve
2026. október 16.
Eredeti leírás
The aim of this randomized crossover clinical trial is to determine the effect of robot assisted gait training combined with physiotherapy on body composition and functional variables in a pediatric population with neurodevelopmental disorders.The main questions to answer are:A teljes eredeti leírásKevesebb

Effect of Physiotherapy Based on Robot Assited Gait Training on Body Composition and Functional Variables in Pediatric Patient With Neurodevelopmental Alterations: Randomized and Crossover Clinical Trial

The aim of this randomized crossover clinical trial is to determine the effect of robot assisted gait training combined with physiotherapy on body composition and functional variables in a pediatric population with neurodevelopmental disorders.The main questions to answer are:

* Does this treatment improve body composition parameters? * Does the treatment help maintaining functionality and without causing discomfort or pain?

Participants will perform 2 weekly physiotherapy sessions for 8 weeks, then there will be 4 weeks of washout, afer which each patient will cross over to the other group for 8 more weeks.

Bevonási feltételek: Pediactric population with neurodevelopmental disorders who have been diagnosed with cerebral palsy; With a level IV or V of the GMFCS; Adapted to the school environment (> 6 months); Unable to stand without support; Receiving conventional physiotherapy (> 6 months); Receiving a standing program (standing duration at school: at least 45 minutes/day); With ankle orthosis; Meeting the specific criteria of the exoskeleton manufacturer (ATLAS 2030 Marsibionics https://www.marsibionics.com/): Weight less than 35 kg, Hip width less than 35 cm, Distance from the center of rotation of the hip to that of the knee between 24 and 33 cm, distance from the center of rotation of the knee to that of the ankle between 23 and 32 cm, the ankle can reach close to 90º with or without an orthosis, shoe size less than 33, hip and knee flexion less than or equal to 20º (even after having previously warmed up).

Kizáró feltételek: Children treated surgically within the 1-year period prior to the evaluation date; Uncontrolled epilepsy: active epilepsy resistant to medication; Severe spinal deformity; Severe hip dysplasia; Knee and hip flexion greater than 20º; Skin inflammation and open skin lesions around the trunk or limbs; Pacemaker, defibrillator or osteosynthesis material carriers.

ClinicalTrials.gov NCT06645795