Robot Asissted Training on Neurodevelopmental Alterations

N/AActive Not RecruitingNCT06645795

University of Valencia9 enrolled

Overview

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.

Pediatric population with neurodevelopmental disorders, such as cerebral palsy (CP), levels IV-V of the Gross Motor Function Classification System (GMFCS), do not walk independently due to their significant physical limitations, so their body composition may be altered, which in turn affects their functional level and may lead to the appearance of musculoskeletal complications. Robot assisted gait training (RAGT) offers a new opportunity to improve mobility of pediatric population with CP levels IV-V of GMFCS, although scientific literature is still scarce in this population. The main aim of this study is to determine the effect of RAGT on body composition and functional variables in a pediatric population with neurodevelopmental disorders. Also to analyze changes in functional, musculoeskeletal, and stress biomarkers variables after the intervention, and to evaluate the cardiorespiratory adaptation to the RAGT. A convenience sample of 10-12 participants will be selected, who will serve as their own control. It has been taken into account that previous studies conducted on pediatric population with CP this sample size is adequate. At the beginning of the study, 50% of the participants will be part of the RAGT group, which will perform 2 weekly sessions of RAGT plus conventional therapy; and the other 50% will belong to the conventional physical therapy group. The study consists of phases 1 and 2 of treatment with a washout period between phases: after "phase 1" (8 weeks of therapy in one of the two groups), there will be 4 weeks of washout, after which each patient will cross over to the other group in "phase 2" (for 8 weeks). Participants will be assessed before phase 1 (T1), after phase 1 (T2), before phase 2 (T3) and after phase 2 (T4).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Interventions

Robot assisted gait training plus conventional physical therapyCOMBINATION_PRODUCT

Participants will complete 8 weeks of intervention of robot assisted gait training with the ATLAS 2030 exoskeleton (Marsi Bionics) owned by the school which they attend to. They will have 2 weekly sessions (16 sessions in total) for 4 weeks. Each session will last up to 1 hour (depending on the child's tolerance) although a minimum of 30 minutes per session and a minimum of 12 sessions will be set in this time. The training mode will be automatic. In addition, they will continue to carry out the rest of their usual treatments.

Conventional pjysical therapyOTHER

Participants will complete 8 weeks of conventional therapy, with 2 sessions per week (16 sessions total). During the conventional treatment period, participants will continue with the conventional physical therapy they have received thus far. The content of the usual care treatment does not specifically address gait training, but consists of elements addressing range of motion, tone reduction, balance, activities of daily living, etc. The conventional intervention may be different for each individual based on their needs (to represent usual care), however, participants will be advised not to change the intervention, type, and frequency during the study.

Eligibility

Sex: ALLMin age: 1 YearMax age: 16 Years

Medical Language ↔ Plain English

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