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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05551364
• Other study ID #: A30-ATADES-CP
• Status: Completed
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: December 2023
• Source: MarsiBionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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)

Locations

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

Sponsors (7)

Lead Sponsor	Collaborator
MarsiBionics	ATADES, ATENPACE Madrid, Fundación Bobath Madrid, Hospital Miguel Servet, Spanish National Research Council, Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To quantify number of steps taken within the device	Quantity of steps taken within the exoskeleton	Every session up to 28 sessions
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Changes in the time walked within the device	To assess possible changes in the time walked within the device	Three months
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Acceptability	Measured through the dropout rate of the participants.	at study completion
Secondary	Accessibility	Measure such as the relationship between the number of patients recruited and potential patients who were not recruited	at study completion