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

Usabilidad y Efectividad Del Exoesqueleto ATLAS2030 en Variables físicas, Emocionales y Funcionales en niños Con parálisis Cerebral

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 Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: ATLAS 2030 exoskeleton

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Centre for Automation and Robotics, Marsi Care
  • Madrid, Spain
    • ATENPACE
  • Madrid, Spain
    • Fundación Bobath
  • Zaragoza, Spain
    • Hospital Universitario Miguel Servet
  • Zaragoza, Spain
    • Universidad de Zaragoza
  • Aragón
    • Zaragoza, Aragón, Spain, 35012
      • Colegio de Educación Especial San Martín de Porres (ATADES)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional Treatment; The children will continue with their current rehabilitation program
Experimental: Treatment with the ATLAS 2030 Exoskeleton; The children will receive 2 hours of exoskeleton ATLAS 2030 gait training a week for 3 months	Device: ATLAS 2030 exoskeleton; Individualized Rehabilitation Treatment with the ATLAS 2030 Exoskeleton consists of the following phases: Telephone contact phase (1 session); Inclusion Phase (1 session); Signing of informed consent (1 session); Initial Evaluation Phase (1 session); Treatment Phase (1st part) (7 sessions); Monthly Evaluation Phase (1 session); Treatment Phase (2nd part) (7 sessions); Monthly Evaluation Phase (1 session); Treatment Phase (3rd part) (7 sessions); Final Evaluation Phase and results (2 sessions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Every month up to 3 months
To quantify number of steps taken within the device	Quantity of steps taken within the exoskeleton	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	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	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	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	Every month up to three months
Changes in the time walked within the device	To assess possible changes in the time walked within the device	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	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	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	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	at study completion
Acceptability	Measured through the dropout rate of the participants.	at study completion
Accessibility	Measure such as the relationship between the number of patients recruited and potential patients who were not recruited	at study completion

Collaborators and Investigators

• Sponsor: MarsiBionics
• Collaborators: Universidad de Zaragoza; Hospital Miguel Servet; ATADES; Spanish National Research Council; Fundación Bobath Madrid; ATENPACE Madrid

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Actual): June 2, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: gait; exoskeleton; paediatric; robotic gait assited training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: A30-ATADES-CP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No