Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy

• Registration Number: NCT05551364
• Lead Sponsor: MarsiBionics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-02
• Study Start: 2022-09-05
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Primary Completion: 2023-06-02
• Study Completion: 2023-08-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in spasticity	Every session up to 28 sessions	To evaluate spasticity changes at the lower limb muscle groups after ATLAS 2030 use by Modified Asworth Scale
Changes in the Six-Minute Walking Test performance	Every month up to three months	To assess changes in the distance the child can walk in six minutes by using the Six-Minute Walking Test
Cerebral Palsy Quality of Life	Three months	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
Gross Motor Function Classification System	Every month up to 3 months	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)
To quantify number of steps taken within the device	Every session up to 28 sessions	Quantity of steps taken within the exoskeleton
Changes in joint range of motion	Every session up to 28 sessions	To evaluate the joint range of motion changes at the hip, knee and ankle after the ATLAS 2030 use measured by goniometer
Changes in the 10 Meters Walking Test performance	Every month up to three months	To assess changes in the time needed to walk 10 meters by using the 10 Meters Walking Test
Changes in the Gross Motor Function Measure 88 for children with cerebral palsy (GMFM-88)	Every month up to three months	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
Changes in the time walked within the device	Three months	To assess possible changes in the time walked within the device
Changes in the Functional Independence Measure for Children (WeeFim)	Every month up to three months	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

Secondary Outcome Measures

Name	Time	Method
Accessibility	at study completion	Measure such as the relationship between the number of patients recruited and potential patients who were not recruited
The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)	at study completion	To assess both professionals and patients´satisfaction when using the ATLAS 2030
Acceptability	at study completion	Measured through the dropout rate of the participants.
Safety of the ATLAS 2030	at study completion	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.

Trial Locations

Locations (6)

Colegio de Educación Especial San Martín de Porres (ATADES); 🇪🇸 Zaragoza, Aragón, Spain

ATENPACE; 🇪🇸 Madrid, Spain

Centre for Automation and Robotics, Marsi Care; 🇪🇸 Madrid, Spain

Fundación Bobath; 🇪🇸 Madrid, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Universidad de Zaragoza; 🇪🇸 Zaragoza, Spain