An interventional study of Robot assisted gait training plus conventional physical therapy and Conventional pjysical therapy in Neurodevelopmental Disorders and Cerebral Palsy, sponsored by University of Valencia. Active, not recruiting at 1 site in Spain. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by University of Valencia · Not applicable, Interventional, and Treatment
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:
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).
332 studies on the registry are indexed under Neurodevelopmental Disorders; 143 are open to participants now.
This study's enrollment of 9 is below the median of 90 across 206 interventional studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.
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Exclusion Criteria:
Participants will complete 8 weeks of intervention of robot assisted gait training plus conventional physical therapy.
Combination Product: Robot assisted gait training plus conventional physical therapy
Participants will complete 8 weeks of conventional therapy.
Other: Conventional pjysical 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.
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.
Body composition, fat %
Measured by bioimpedanciometry (BIA): fat (%).
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Body composition, fat in kg
Measured by bioimpedanciometry (BIA): fat (kg)
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Body composition, lean mass (kg)
Measured by bioimpedanciometry (BIA): lean mass (kg), lean mass (%), total mass (%), dry lean weight (%), Body mass index, and resistance at 50 kHz measured in Ohms
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Body composition, lean mass (%)
Measured by bioimpedanciometry (BIA): lean mass (%).
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Body composition, dry lean weight
Measured by bioimpedanciometry (BIA): dry lean weight (%).
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Bone mineral density.
Measured by ultrasound densitometry.
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, clinical data.
Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): clinical data.
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, musculoskeletal history.
Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): musculoskeletal history (previous history of fractures, subluxation or hip dysplasia), technical aids that are currently needed, neurorehabilitation treatments that are currently received at the center.
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, disability assessment
Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): disability assessment using the Pediatric Evaluation Disability Inventory (PEDI), range of motion of lower limb joints (it will be measured with a goniometer for hip, knee and ankle), spasticity in the muscles of the lower limbs (it will be measured with the modified Asworth Scale), and also the functional capacity using the Functional Mobility Scale (FMS).
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, range of motion
Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): range of motion of lower limb joints (it will be measured with a goniometer for hip, knee and ankle), spasticity in the muscles of the lower limbs (it will be measured with the modified Asworth Scale), and also the functional capacity using the Functional Mobility Scale (FMS).
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, spasticity
Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): spasticity in the muscles of the lower limbs (it will be measured with the modified Asworth Scale), and also the functional capacity using the Functional Mobility Scale (FMS).
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Functional and musculoeskeletal assessmement, functional capacity
Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): functional capacity using the Functional Mobility Scale (FMS).
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Anthropometric measurements, weight
Weight (kg)
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Anthropometric measurements, height
Height (cm)
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Anthropometric measurements, BMI
Body Mass Index (kg/m2)
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Anthropometric measurements, circumferences
circumferences of arm, calf, waist and hip (cm)
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Nutritional status
The nutritional status of each participant will be defined by weight-for-age percentiles, height-for-age percentiles, weight-for-height ratio, and BMI-for-age, following WHO growth charts and ASPEN standards, as in previous studies in this population.
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Postural ability
Posture and Postural Ability Scale (PPAS) in sitting, supine and prone.
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Cardio-respiratory measurement, heart rate
Heart rate (HR) will be measured by pulse oximetry.
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Cardio-respiratory measurement, oxygen saturation
Oxygen saturation (SaO2) will be measured by pulse oximetry.
Time frame: Before phase 1 (T1, pre intervention), after phase 1 (T2, after 8 weeks intervention), before phase 2 (T3, pre intervention) and after phase 2 (T4, after 8 weeks intervention).
Parameters of the RAGT intervention, total time
During the RAGT intervention sessions, the following will also be recorded: Total session time (in minutes).
Time frame: During RAGT intervention sessions (8 weeks).
Parameters of the RAGT intervention, distance.
During the RAGT intervention sessions, the following will also be recorded: number of steps and distance walked (in metres), walking speed (the two-minute walk test will be used), spasticity of the lower limbs before and after walking with the robot (modified Asworth scale), range of motion of the lower limb joints, recording of cardiorespiratory variables during walking with an exoskeleton (HR pre and post session, SaO2 pre and post session), respiratory rate and the Physiological Cost Index will be calculated ((Working HR - Resting HR) / Walking speed).
Time frame: During RAGT intervention sessions (8 weeks).
Parameters of the RAGT intervention, walking speed
During the RAGT intervention sessions, the following will also be recorded: walking speed (the two-minute walk test will be used), spasticity of the lower limbs before and after walking with the robot (modified Asworth scale), range of motion of the lower limb joints, recording of cardiorespiratory variables during walking with an exoskeleton (HR pre and post session, SaO2 pre and post session), respiratory rate and the Physiological Cost Index will be calculated ((Working HR - Resting HR) / Walking speed).
Time frame: During RAGT intervention sessions (8 weeks).
Parameters of the RAGT intervention, spasticity
During the RAGT intervention sessions, the following will also be recorded: spasticity of the lower limbs before and after walking with the robot (modified Asworth scale).
Time frame: During RAGT intervention sessions (8 weeks).
Parameters of the RAGT intervention, range of motion
During the RAGT intervention sessions, the following will also be recorded: range of motion of the lower limb joints.
Time frame: During RAGT intervention sessions (8 weeks).
Parameters of the RAGT intervention, heart rate
During the RAGT intervention sessions, the following will also be recorded: cardiorespiratory variables during walking with an exoskeleton, heart rate (HR) pre and post session.
Time frame: During RAGT intervention sessions (8 weeks).
Parameters of the RAGT intervention, SaO2
During the RAGT intervention sessions, the following will also be recorded: SaO2 pre and post session
Time frame: During RAGT intervention sessions (8 weeks).
Parameters of the RAGT intervention, respiratory rate
During the RAGT intervention sessions, the following will also be recorded: respiratory rate (cycles/minute)
Time frame: During RAGT intervention sessions (8 weeks).
Parameters of the RAGT intervention, Physiological Cost Index
During the RAGT intervention sessions, the following will also be recorded: Physiological Cost Index will be calculated ((Working HR - Resting HR) / Walking speed).
Time frame: During RAGT intervention sessions (8 weeks).
Pain or discomfort
Objectively measured by means of a saliva sample, analyzing the levels of salivary alpha-amylase (α-amylase) activity and salivary cortisol concentration. The first sample represents the child's initial stress level before the intervention program, and the second sample represents the child's stress response to the intervention. The first 5 days of conventional treatment are repeated at the same time. (Zhao, 2015) The saliva samples will be obtained using a Salivette device and processed in the favilities of IVIRMA Global Research Alliance, IVI Foundation -La Fe Health Research Institute.
Time frame: Before and after the first 5 days of treatment (week 1 of each phase)
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Valencia