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Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases | Clinical Trials | Clareo Health

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Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases

Evaluation of the Safety of ATLAS 2030 in the Application of Robot-assisted Physical Therapy to Children With Neuromuscular Diseases Phase I

NCT04837157•MarsiBionics

View on ClinicalTrials.gov

Summary

This study aims to evaluate the safety, usability and acceptability of a motorized mobility assistance exoskeleton. The protocol explores the use of the motorized device during static and dynamic rehabilitation sessions focused on walking and functional activities, with the expectation of evaluating the safety and usability of the device in the population studied. The protocol has been focused on defining how the device can be used appropriately in this population in a safe and effective manner by rehabilitation specialists. The study also aims to assess the safety of clinical staff who implement the intervention.

Eligibility

Age

3 - 14 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Maximum user weight of 35 kg
•Thigh length (distance from the greater trochanter to the lateral condyle of the tibia) from 24 cm to 40 cm.
•Leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23 to 39 cm.
•Pelvis width (between greater trochanters) from 24 to 35 cm.
•Ability to achieve ankle dorsiflexion to 90˚
•20º or more hip flessum.
•20º or more knee flessum.
•No allergies to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
•Informed consent signed by legal guardians.
•Confirmed diagnosis of cerebral palsy or neuromuscular disease affecting walking ability at early development stages
+6 more criteria

Exclusion Criteria

•Patient's inability to follow simple instructions and/or communicate discomfort.
•Invasive or non-invasive daytime ventilation.
•Orthostatic hypotension.
•20º or more hip flessum.
•20º or more knee flessum
•Scoliosis with a Cobb angle of more than 25º that cannot wear a corset during the test.
•Severe skin injury to the lower extremities.
•Scheduled surgery (spine, extremities) during the period of the study or surgery performed (spine, extremities) in the last 6 months.
•History of fracture without trauma.
•History of traumatic bone fracture in lower limbs or pelvic girdle in the last 3 months
+4 more criteria

Locations (1)

MarsiCare

Arganda, Madrid, Spain

Key Dates

Start Date

October 15, 2020

Primary Completion Date

December 31, 2020

Completion Date

January 31, 2021

Last Updated

April 8, 2021

Enrollment

ACTUAL participants

Conditions

Cerebral PalsySMA IINeuromuscular Diseases

Interventions

Exoskeleton rehabilitation

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

View study

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: April 8, 2021Data 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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Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases

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

Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

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

Swiss Cerebral Palsy Registry

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