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

NCT ID: NCT05551364

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2023-08-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Treatment

The children will continue with their current rehabilitation program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment with the ATLAS 2030 Exoskeleton

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

Group Type: EXPERIMENTAL

ATLAS 2030 exoskeleton

Intervention Type: 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)

Interventions

ATLAS 2030 exoskeleton

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)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Miguel Servet

OTHER

Sponsor Role: collaborator

ATADES

UNKNOWN

Sponsor Role: collaborator

Universidad de Zaragoza

OTHER

Sponsor Role: collaborator

Spanish National Research Council

OTHER_GOV

Sponsor Role: collaborator

Fundación Bobath Madrid

UNKNOWN

Sponsor Role: collaborator

ATENPACE Madrid

UNKNOWN

Sponsor Role: collaborator

MarsiBionics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Universidad de Zaragoza

Zaragoza, , Spain

Countries

Spain

Other Identifiers

A30-ATADES-CP

Identifier Type: -

Identifier Source: org_study_id