Clinical trial NCT05551364: Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy
Official title: Usabilidad y Efectividad Del Exoesqueleto ATLAS2030 en Variables físicas, Emocionales y Funcionales en niños Con parálisis Cerebral
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: exoskeleton
paediatric
gait
robotic gait assited training
Lead sponsor: MarsiBionics
Sponsor class: INDUSTRY
Collaborators: name: Hospital Miguel Servet
name: ATADES
name: Universidad de Zaragoza
name: Spanish National Research Council
name: Fundación Bobath Madrid
name: ATENPACE Madrid
First posted: 2022-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess the usability and efficacy of receiving therapy with the peaditric exoskeleton ATLAS 2030in children with gait impairment due to a cerebral palsy condition. It will be valued the impact of rehabilitation with the exoskeleton at the physical level on parameters such as joint range, spasticity, as well as the impact in quality of life. It is also assessed the impact at the level of functionality of the participants, through the administration of different functional assessment scales.


Eligibility criteria: Inclusion Criteria:

* Medical authorization to for standing, gait training and weight bearing.
* Maximum user weight of 35 kg.
* 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.
* Hip width (between greater trochanteres) less than or equal to 35 cm.
* Do not have an allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
* Ability to achieve the neutral position of the ankle, during the use of the device with or without technical aids.
* Informed consent signed by legal guardians.
* Confirmed diagnosis of cerebral palsy affecting the ability to walk.
* Stable medical condition without modifications of the specific medication for the disease in the last 6 months, and other additional medication in the last month.
* Patient in follow-up according to the normal standards recommended for his illness.

Exclusion Criteria:

* More than 20º of hip flessum at the time of using the exoskeleton.
* More than 20º of knee flessum at the time of using the exoskeleton.
* 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.
* Refusal of the patient or legal guardian to include the child in the study.
* Skin problems (diseases, allergies, sensitivity ...) that prevent the use of exoskeleton accessories on the patient's skin.
* Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.

Primary outcomes:
measure: Gross Motor Function Classification System
timeFrame: Every month up to 3 months
measure: To quantify number of steps taken within the device
timeFrame: Every session up to 28 sessions
measure: Changes in joint range of motion
timeFrame: Every session up to 28 sessions
measure: Changes in spasticity
timeFrame: Every session up to 28 sessions
measure: Changes in the Six-Minute Walking Test performance
timeFrame: Every month up to three months
measure: Changes in the 10 Meters Walking Test performance
timeFrame: Every month up to three months
measure: Changes in the time walked within the device
timeFrame: Three months
measure: Changes in the Gross Motor Function Measure 88 for children with cerebral palsy (GMFM-88)
timeFrame: Every month up to three months
measure: Changes in the Functional Independence Measure for Children (WeeFim)
timeFrame: Every month up to three months
measure: Cerebral Palsy Quality of Life
timeFrame: Three months
Secondary outcomes:
measure: Safety of the ATLAS 2030
timeFrame: at study completion
measure: The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
timeFrame: at study completion
measure: Acceptability
timeFrame: at study completion
measure: Accessibility
timeFrame: at study completion
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Colegio de Educación Especial San Martín de Porres (ATADES)
state: Aragón
city: Madrid
country: Spain
facility: ATENPACE
city: Madrid
country: Spain
facility: Centre for Automation and Robotics, Marsi Care
city: Madrid
country: Spain
facility: Fundación Bobath
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Zaragoza
country: Spain
facility: Universidad de Zaragoza
Study officials:
References: