Efficacy of a Rehabilitation Program With the Pediatric Exoskeleton ATLAS 2030 in Pediatric Patients With Cerebral Palsy

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: ATLAS 2030

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Eva Barquín Santos; Phone Number: +34918711900; Email: eva.barquin@marsibionics.com

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de octubre
    • Contact: Sofía García de las Peñas
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: Sandra Espinosa García
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital Universitario Gregorio Marañón
    • Contact: Olga Arroyo Riaño
  • Madrid, Spain, 28009
    • Recruiting
    • Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación
    • Contact: María Teresa Vara Arias
  • Madrid, Spain, 28009
    • Recruiting
    • Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia
    • Contact: Ignacio Martínez Caballero

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exoskeleton group; sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their of their routine rehabilitation	Device: ATLAS 2030; sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their routine rehabilitation
Control group; The children included in the control group will continue receiving their usual conventional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross Motor Function Measure-88 (GMFM-88)	To measure changes in gross motor function in children with cerebral palsy using the Gross Motor Functional Measure-88. The minimum value is 0 and the maximum value is 100 .When the GMFM score is lower, the skill level is lower.	At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale (MAS)	changes in spasticity measured by the Modified Ashworth Scale (MAS). The spasticity of each muscle group is measured with a scale scored from 0 to 4, where 0 means no spasticity and 4 means the joint is fixed and therefore, the highest level of spasticity	Through study completion, along 1 year
Pediatric Quality of Life Inventory (PedsQLTM)	Changes in self perceived quality of life measured by the Pediatric Quality of Life Inventory (PedsQLTM). Every item is measured on a scale from 0 (higher quality of life) to 4 (lower quality of life)	At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Changes in Gait Deviation Index (GDI)	Changes in Gait Deviation Index (GDI) measured with a tridimensional motion analysis system	At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)

Collaborators and Investigators

• Sponsor: MarsiBionics
• Collaborators: Hospital General Universitario Gregorio Marañon; Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Hospital Universitario 12 de Octubre; National Research Council, Spain; Hospital Universitario La Paz
• Investigators: Principal Investigator: Olga Arroyo Riaño, Hospital Universitario Gregorio Marañón; Principal Investigator: María Teresa Vara Arias, Hospital Infantil Universitario Nino Jesus; Principal Investigator: Ignacio Martínez Caballero, Hospital Infantil Universitario Nino Jesus; Principal Investigator: Sandra Espinosa García, Hospital Univsersitario La Paz; Principal Investigator: Sofía García de las Peñas, Hospital 12 de Octubre; Principal Investigator: Elena García Armada, National Research Council, Spain

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: gait; rehabilitation; cerebral palsy; exoskeleton
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: SERMAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No