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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926635
• Other study ID #: SERMAS
• Status: Recruiting
• Start date: August 3, 2023
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: MarsiBionics
• Contact: Eva Barquín Santos
• Phone: +34918711900
• Email: eva.barquin[@]marsibionics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia	Madrid

Sponsors (6)

Lead Sponsor	Collaborator
MarsiBionics	Hospital General Universitario Gregorio Marañon, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital Universitario 12 de Octubre, Hospital Universitario La Paz, National Research Council, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)