Robot Asissted Training on Neurodevelopmental Alterations
- Conditions
- Neurodevelopmental DisordersCerebral Palsy
- Registration Number
- NCT06645795
- Lead Sponsor
- University of Valencia
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 9
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Body composition, 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). Measured by bioimpedanciometry (BIA): fat (%).
Body composition, fat in 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). Measured by bioimpedanciometry (BIA): fat (kg)
Body composition, lean mass (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). 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
Body composition, 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). Measured by bioimpedanciometry (BIA): lean mass (%).
Body composition, 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). Measured by bioimpedanciometry (BIA): dry lean weight (%).
Bone mineral density. 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). Measured by ultrasound densitometry.
- Secondary Outcome Measures
Name Time Method Functional and musculoeskeletal assessmement, 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). Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): clinical data.
Functional and musculoeskeletal assessmement, musculoskeletal history. 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). 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.
Functional and musculoeskeletal assessmement, disability assessment 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). 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).
Functional and musculoeskeletal assessmement, range of motion 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). 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).
Functional and musculoeskeletal assessmement, spasticity 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). 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).
Functional and musculoeskeletal assessmement, functional capacity 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). Measured by the "Cerebral Palsy Follow-Up Program" (CPUP): functional capacity using the Functional Mobility Scale (FMS).
Anthropometric measurements, 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). Weight (kg)
Anthropometric measurements, height 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). Height (cm)
Anthropometric measurements, BMI 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 Mass Index (kg/m2)
Anthropometric measurements, circumferences 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). circumferences of arm, calf, waist and hip (cm)
Nutritional status 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). 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.
Postural ability 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). Posture and Postural Ability Scale (PPAS) in sitting, supine and prone.
Cardio-respiratory measurement, heart rate 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). Heart rate (HR) will be measured by pulse oximetry.
Cardio-respiratory measurement, oxygen saturation 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). Oxygen saturation (SaO2) will be measured by pulse oximetry.
Trial Locations
- Locations (1)
University of Valencia
🇪🇸Valencia, València, Spain