NCT06645795

Robot Asissted Training on Neurodevelopmental Alterations

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Neurodevelopmental Disorders
• Cerebral Palsy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Robot assisted gait training plus conventional physical therapy	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.
OTHER	Conventional pjysical therapy	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.

Timeline

• Start date: 2024-10-17
• Primary completion: 2025-03-01
• Completion: 2026-05-01
• First posted: 2024-10-17
• Last updated: 2024-12-05

Locations

1 site across 1 country: Spain