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

NCT05551364 | Completed DMC

• 1 other identifier: A30-ATADES-CP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

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.

Conditions

Cerebral Palsy

Keywords

exoskeleton; paediatric; gait; robotic gait assited training

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (4)

• Safety of the ATLAS 2030

  at study completion

• The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)

  at study completion

• Acceptability

  at study completion

• Accessibility

  at study completion

Study Arms (2)

Conventional Treatment

NO INTERVENTION

The children will continue with their current rehabilitation program

Treatment with the ATLAS 2030 Exoskeleton

EXPERIMENTAL

The children will receive 2 hours of exoskeleton ATLAS 2030 gait training a week for 3 months

Device: ATLAS 2030 exoskeleton

Interventions

ATLAS 2030 exoskeleton DEVICE

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)

Treatment with the ATLAS 2030 Exoskeleton

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MarsiBionics: lead
• Hospital Miguel Servet: collaborator
• ATADES: collaborator
• Universidad de Zaragoza: collaborator
• Spanish National Research Council: collaborator
• Fundación Bobath Madrid: collaborator
• ATENPACE Madrid: collaborator

Study Sites (6)

Colegio de Educación Especial San Martín de Porres (ATADES)

Zaragoza, Aragon, 35012, Spain

Location

ATENPACE

Madrid, Spain

Location

Centre for Automation and Robotics, Marsi Care

Madrid, Spain

Location

Fundación Bobath

Madrid, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Universidad de Zaragoza

Zaragoza, Spain

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 22, 2022
• Study Start: September 5, 2022
• Primary Completion: June 2, 2023
• Study Completion: August 30, 2023
• Last Updated: September 27, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)