Robot Asissted Training on Neurodevelopmental Alterations (RAGTNEUDEV)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Palsy; Neurodevelopmental Disorders
• Intervention / Treatment: Combination product: Robot assisted gait training plus conventional physical therapy; Other: Conventional pjysical therapy

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).

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • València
    • Valencia, València, Spain, 46010
      • University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: robot assisted gait training plus conventional physical therapy; 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 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.
Active Comparator: Conventional physical therapy; Participants will complete 8 weeks of conventional therapy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition, fat %	Measured by bioimpedanciometry (BIA): fat (%).	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)	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	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 (%).	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 (%).	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.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional and musculoeskeletal assessmement, clinical data.	Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): clinical data.	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.	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).	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).	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).	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).	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)	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)	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)	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)	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.	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.	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.	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.	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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parameters of the RAGT intervention, total time	During the RAGT intervention sessions, the following will also be recorded: Total session time (in minutes).	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).	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).	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).	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.	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.	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	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)	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).	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.	Before and after the first 5 days of treatment (week 1 of each phase)

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Instituto de Investigacion Sanitaria La Fe; CEE Cruz Roja Valencia
• Investigators: Principal Investigator: ANNA ARNAL-GOMEZ, Dr., University of Valencia

Publications and helpful links

General Publications

• Engsberg JR, Ross SA, Collins DR. Increasing ankle strength to improve gait and function in children with cerebral palsy: a pilot study. Pediatr Phys Ther. 2006 Winter;18(4):266-75. doi: 10.1097/01.pep.0000233023.33383.2b.
• McCormick AM, Alazem H, Zaidi S, Barrowman NJ, Ward LM, McMillan HJ, Longmuir P, Larin M, Dalton K. A randomized, cross-over trial comparing the effect of innovative robotic gait training and functional clinical therapy in children with cerebral palsy; a protocol to test feasibility. Contemp Clin Trials. 2023 Apr;127:107086. doi: 10.1016/j.cct.2023.107086. Epub 2023 Jan 17.
• Peungsuwan P, Parasin P, Siritaratiwat W, Prasertnu J, Yamauchi J. Effects of Combined Exercise Training on Functional Performance in Children With Cerebral Palsy: A Randomized-Controlled Study. Pediatr Phys Ther. 2017 Jan;29(1):39-46. doi: 10.1097/PEP.0000000000000338.
• Zhao X, Chen M, Du S, Li H, Li X. Evaluation of stress and pain in young children with cerebral palsy during early developmental intervention programs: a descriptive study. Am J Phys Med Rehabil. 2015 Mar;94(3):169-75; quiz 176-9. doi: 10.1097/PHM.0000000000000252.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: body composition; physical therapy; cerebral palsy; robot assisted gait training; neurodevelopmental disorders; musculoeskeletal
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Brain Damage, Chronic; Neurodevelopmental Disorders; Cerebral Palsy
• Other Study ID Numbers: RAGT_NEUROVELOP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No