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

NCT05926635 | Active Not Recruiting DMC

• 1 other identifier: SERMAS
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Cerebral Palsy

Keywords

exoskeleton; cerebral palsy; gait; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Modified Ashworth Scale (MAS)

  Through study completion, along 1 year

• Pediatric Quality of Life Inventory (PedsQLTM)

  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)

  At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)

Study Arms (2)

Exoskeleton group

sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their of their routine rehabilitation

Device: ATLAS 2030

Control group

The children included in the control group will continue receiving their usual conventional therapy

Interventions

ATLAS 2030 DEVICE

sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their routine rehabilitation

Exoskeleton group

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• MarsiBionics: lead
• National Research Council, Spain: collaborator
• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: collaborator
• Hospital Universitario La Paz: collaborator
• Hospital Universitario 12 de Octubre: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator

Study Sites (5)

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación

Madrid, 28009, Spain

Location

Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia

Madrid, 28009, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Olga Arroyo Riaño

  Hospital Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

• María Teresa Vara Arias

  Hospital Infantil Universitario Niño Jesús

  PRINCIPAL INVESTIGATOR

• Ignacio Martínez Caballero

  Hospital Infantil Universitario Niño Jesús

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: July 3, 2023
• Study Start: August 3, 2023
• Primary Completion: May 11, 2025
• Study Completion: May 11, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)