Robot assisted gait training plus conventional physical therapyConventional pjysical therapy
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.
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.
Study 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.
Eligibility
Sex
ALL
Min age
1 Year
Max age
16 Years
Healthy volunteers
No
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 outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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