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Robot Asissted Training on Neurodevelopmental Alterations

NCT06645795 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Instituto de Investigacion Sanitaria La Fe

    collaborator OTHER

  • CEE Cruz Roja Valencia

    collaborator UNKNOWN

  • University of Valencia

    lead OTHER

Principal Investigators

  • ANNA ARNAL-GOMEZ, Dr. · University of Valencia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-17
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06645795 on ClinicalTrials.gov