Clinical trial NCT05926635: Efficacy of a Rehabilitation Program With the Pediatric Exoskeleton ATLAS 2030 in Pediatric Patients With Cerebral Palsy
Official title: Efficacy of a Rehabilitation Program With the Pediatric Exoskeleton ATLAS 2030 in Pediatric Patients With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cerebral Palsy
Keywords: exoskeleton
cerebral palsy
gait
rehabilitation
Lead sponsor: MarsiBionics
Sponsor class: INDUSTRY
Collaborators: name: National Research Council, Spain
name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
name: Hospital Universitario La Paz
name: Hospital Universitario 12 de Octubre
name: Hospital General Universitario Gregorio Marañon
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with cerebral palsy with Gross Motor Function Classification level III (children walk using a hand-held mobility device in most indoor settings) or IV (children use methods of mobility that require physical assistance or powered mobility in most settings).

Brief summary: Cerebral Palsy (CP) is the first cause of motor disability in children worldwide. ATLAS 2030 is a robotic gait exoskeleton designed to rehabilitate children with motor disability. The objective of this study is to analyse the efficacy of a training program with ATLAS 2023 in chilren with CP.

Detailed description: A sample of children with CP will be divided into 2 groups, the experimental group will receive 32 sesions withe the ATLAS 2030 exoskeleton, whereas the control group will continue to receive their regular conventional therapy. Assessments will be performed at the beginning and the end of the intervention, as well as after 6, 9 and 12 months of the end of the intervention for follow-up.

Eligibility criteria: Inclusion Criteria:

* Medical authorization for standing, gait training and weight bearing.
* Informed consent signed by legal guardians.
* Confirmed diagnosis of cerebral palsy GMFCS levels III or IV.
* Proper family acceptance and commitment level.
* Receiving a minimum of 2 hours of therapy/activities promoting physical activity.
* Maximum user weight of 35 kg.
* Hip width (between greater trochanteres) less than or equal to 35 cm.
* Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 24cm to 33cm.
* Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23cm to 32cm.
* Shoe size 27-33 (EU)

Exclusion Criteria:

* More than 8 sessions of robotic therapy during a month in the previous year to the beginning of the study.
* Intensive rehabilitation during the study.
* Imposibility of the family to fulfill treatment calendar.
* Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
* More than 20º of hip and/or knee flessum at the time of using the exoskeleton.
* Necessity to walk with 10º of hip abduction.
* Necessity to walk with more than 9º of ankle dorsiflexion or plantar flexion or impossibility to use an orthosis to reach 90º in the ankle joint.
* Severe skin lesion on parts of the lower extremities that are in contact with the device.
* Scheduled surgery (rachis, limbs) for the duration of the study or surgery performed (rachis, extremities) in the last 6 months.
* History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
* Severe rigid orthopedic deformities of the spine and/or lower limbs.
* Cognitive or conductual disorders that may lead to a lack of adherence to the attachment to the device.
* Conditions that provoke exercise intolerance.
* Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness or the inability to understand simple comands.
* Allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.

Primary outcomes:
measure: Gross Motor Function Measure-88 (GMFM-88)
timeFrame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Through study completion, along 1 year
measure: Pediatric Quality of Life Inventory (PedsQLTM)
timeFrame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
measure: Changes in Gait Deviation Index (GDI)
timeFrame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación
city: Madrid
country: Spain
facility: Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario Gregorio Marañón
name: Olga Arroyo Riaño
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Infantil Universitario Niño Jesús
name: María Teresa Vara Arias
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Infantil Universitario Niño Jesús
name: Ignacio Martínez Caballero
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univsersitario La Paz
name: Sandra Espinosa García
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital 12 de Octubre
name: Sofía García de las Peñas
role: PRINCIPAL_INVESTIGATOR
affiliation: National Research Council, Spain
name: Elena García Armada
role: PRINCIPAL_INVESTIGATOR
References: