Clinical trial NCT06645795: Robot Asissted Training on Neurodevelopmental Alterations
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neurodevelopmental Disorders
Cerebral Palsy
Keywords: cerebral palsy
neurodevelopmental disorders
robot assisted gait training
physical therapy
body composition
musculoeskeletal
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Instituto de Investigacion Sanitaria La Fe
name: CEE Cruz Roja Valencia
First posted: 2024-10-17
Enrollment: 9
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover clinical trial.
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Body composition, fat %
timeFrame: 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).
measure: Body composition, fat in kg
timeFrame: 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).
measure: Body composition, lean mass (kg)
timeFrame: 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).
measure: Body composition, lean mass (%)
timeFrame: 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).
measure: Body composition, dry lean weight
timeFrame: 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).
measure: Bone mineral density.
timeFrame: 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 outcomes:
measure: Functional and musculoeskeletal assessmement, clinical data.
timeFrame: 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).
measure: Functional and musculoeskeletal assessmement, musculoskeletal history.
timeFrame: 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).
measure: Functional and musculoeskeletal assessmement, disability assessment
timeFrame: 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).
measure: Functional and musculoeskeletal assessmement, range of motion
timeFrame: 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).
measure: Functional and musculoeskeletal assessmement, spasticity
timeFrame: 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).
measure: Functional and musculoeskeletal assessmement, functional capacity
timeFrame: 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).
measure: Anthropometric measurements, weight
timeFrame: 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).
measure: Anthropometric measurements, height
timeFrame: 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).
measure: Anthropometric measurements, BMI
timeFrame: 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).
measure: Anthropometric measurements, circumferences
timeFrame: 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).
measure: Nutritional status
timeFrame: 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).
measure: Postural ability
timeFrame: 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).
measure: Cardio-respiratory measurement, heart rate
timeFrame: 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).
measure: Cardio-respiratory measurement, oxygen saturation
timeFrame: 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 outcomes:
measure: Parameters of the RAGT intervention, total time
timeFrame: During RAGT intervention sessions (8 weeks).
measure: Parameters of the RAGT intervention, distance.
timeFrame: During RAGT intervention sessions (8 weeks).
measure: Parameters of the RAGT intervention, walking speed
timeFrame: During RAGT intervention sessions (8 weeks).
measure: Parameters of the RAGT intervention, spasticity
timeFrame: During RAGT intervention sessions (8 weeks).
measure: Parameters of the RAGT intervention, range of motion
timeFrame: During RAGT intervention sessions (8 weeks).
measure: Parameters of the RAGT intervention, heart rate
timeFrame: During RAGT intervention sessions (8 weeks).
measure: Parameters of the RAGT intervention, SaO2
timeFrame: During RAGT intervention sessions (8 weeks).
measure: Parameters of the RAGT intervention, respiratory rate
timeFrame: During RAGT intervention sessions (8 weeks).
measure: Parameters of the RAGT intervention, Physiological Cost Index
timeFrame: During RAGT intervention sessions (8 weeks).
measure: Pain or discomfort
timeFrame: Before and after the first 5 days of treatment (week 1 of each phase)
Locations:
city: Valencia
country: Spain
facility: University of Valencia
state: València
Study officials:
affiliation: University of Valencia
name: ANNA ARNAL-GOMEZ, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.