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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

NCT05551364•MarsiBionics

View on ClinicalTrials.gov

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.

Eligibility

Age

3 - 14 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.

Locations (6)

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

Key Dates

Start Date

September 5, 2022

Primary Completion Date

June 2, 2023

Completion Date

August 30, 2023

Last Updated

September 27, 2024

Enrollment

ACTUAL participants

Conditions

Cerebral Palsy

Interventions

ATLAS 2030 exoskeleton

DEVICE

Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy

NCT04630392

Cerebral Palsy

View study

RECRUITING

The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes

NCT05901259

Cerebral PalsyMultiple Sclerosis+3 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy

The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes

Effects of Play Based Neural Mobilisation Activities on Hand Grip Strength and Dexterity in Cerebral Palsy Children

Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

Swiss Cerebral Palsy Registry

Remote Ischemic Conditioning and Spinal Reflex Modulation in Children With Cerebral Palsy