Robot Asissted Training on Neurodevelopmental Alterations (RAGTNEUDEV)

University of Valencia

Status: Active, not recruiting

Conditions: Cerebral Palsy; Neurodevelopmental Disorders

Treatments: Other: Conventional pjysical therapy; Combination Product: Robot assisted gait training plus conventional physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06645795

RAGT_NEUROVELOP

Details and patient eligibility

About

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.

Full 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).

Enrollment: 9 patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

robot assisted gait training plus conventional physical therapy

Experimental group

Description:

Participants will complete 8 weeks of intervention of robot assisted gait training plus conventional physical therapy.

Treatment:

Combination Product: Robot assisted gait training plus conventional physical therapy

Conventional physical therapy

Active Comparator group

Description:

Participants will complete 8 weeks of conventional therapy.

Treatment:

Other: Conventional pjysical therapy