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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Individualized Rehabilitation Treatment with the ATLAS 2030 Exoskeleton consists of the following phases: 1. Telephone contact phase (1 session) 2. Inclusion Phase (1 session) 3. Signing of informed consent (1 session) 4. Initial Evaluation Phase (1 session) 5. Treatment Phase (1st part) (7 sessions) 6. Monthly Evaluation Phase (1 session) 7. Treatment Phase (2nd part) (7 sessions) 8. Monthly Evaluation Phase (1 session) 9. Treatment Phase (3rd part) (7 sessions) 10. Final Evaluation Phase and results (2 sessions)
Colegio de Educación Especial San Martín de Porres (ATADES)
Zaragoza, Aragon, Spain
ATENPACE
Madrid, Spain
Centre for Automation and Robotics, Marsi Care
Madrid, Spain
Fundación Bobath
Madrid, Spain
Gross Motor Function Classification System
To indentify the diffrent levels of the Gross Motor Function Classification System who can use the ATLAS 2030 exoskeleton. The Gross Motor Function Classification System goes from Level 1 (can walk indoors and outdoors and climb stairs without using hands for support; can perform usual activities such as running and jumping; has decreased speed, balance and coordination) to Level 5 (has physical impairments that restrict voluntary control of movement and the ability to maintain head and neck position against gravity; is impaired in all areas of motor function; cannot sit or stand independently, even with adaptive equipment; cannot independently walk, though may be able to use powered mobility)
Time frame: Every month up to 3 months
To quantify number of steps taken within the device
Quantity of steps taken within the exoskeleton
Time frame: Every session up to 28 sessions
Changes in joint range of motion
To evaluate the joint range of motion changes at the hip, knee and ankle after the ATLAS 2030 use measured by goniometer
Time frame: Every session up to 28 sessions
Changes in spasticity
To evaluate spasticity changes at the lower limb muscle groups after ATLAS 2030 use by Modified Asworth Scale
Time frame: Every session up to 28 sessions
Changes in the Six-Minute Walking Test performance
To assess changes in the distance the child can walk in six minutes by using the Six-Minute Walking Test
Time frame: Every month up to three months
Changes in the 10 Meters Walking Test performance
To assess changes in the time needed to walk 10 meters by using the 10 Meters Walking Test
Time frame: Every month up to three months
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Hospital Universitario Miguel Servet
Zaragoza, Spain
Universidad de Zaragoza
Zaragoza, Spain
Changes in the time walked within the device
To assess possible changes in the time walked within the device
Time frame: Three months
Changes in the Gross Motor Function Measure 88 for children with cerebral palsy (GMFM-88)
To evaluate possible changes in the gross motor function after 3 months of ATLAS 2030 use twice a week where a higher score means child´s gross motor function is better
Time frame: Every month up to three months
Changes in the Functional Independence Measure for Children (WeeFim)
To evaluate possible changes in the overall functionality after 3 months of ATLAS 2030 use twice a week by using the Functional Independence Measure for Children where a higher score means the child is more functional, more independant
Time frame: Every month up to three months
Cerebral Palsy Quality of Life
To assess possible changes in the quality of life of the children after using the ATLAS 2030 for 3 months twice a week by using the Cerebral Palsy Quallity of Life scale where a higher percentage means a better quality of life
Time frame: Three months
Safety of the ATLAS 2030
Measured as the occurrence of adverse events such as onset of pain, fatigue, presence of falls or alteration of the integrity of the user's skin, by the use of the device.
Time frame: at study completion
The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
To assess both professionals and patients´satisfaction when using the ATLAS 2030
Time frame: at study completion
Acceptability
Measured through the dropout rate of the participants.
Time frame: at study completion
Accessibility
Measure such as the relationship between the number of patients recruited and potential patients who were not recruited
Time frame: at study completion