Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.

Marsi Bionics

Status

Not yet enrolling

Conditions

Neuromuscular Disorders

Neurodevelopmental Disorders

Treatments

Device: CLINICAL EXPLORER

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07159360

EXC

Details and patient eligibility

About

Neurodevelopmental disorders often result in abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as the inability to stand and walk. CLINICAL EXPLORER is a clinical-use robotic device for gait training, representing the evolution of the ATLAS 2030 exoskeleton and the EXPLORER device for home use. The aim of this study is to evaluate the safety and usability of CLINICAL EXPLORER .

Full description

Neuromuscular and neurological disorders in children cause muscle weakness and spasticity, leading to severe motor dysfunctions such as the inability to maintain posture or walk. Manually assisted gait training can be physically demanding for therapists, which is why robotic devices have been developed to reduce their workload, provide objective assessments through integrated sensors, and improve rehabilitation quality. Beyond mobilizing muscles and joints, these devices enhance brain neuroplasticity and the child's connectivity with their environment, positively impacting self-esteem and social interaction. A clinical-use robotic device for gait training has been developed, representing the evolution of the ATLAS 2030 exoskeleton and the EXPLORER device for home use.

Enrollment

60 estimated patients

Sex

All

Ages

2 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Phase 0

Age between 2 and 17 years.
Consent from the participant or legal guardian to participate in the study.
No diagnosis of neurodevelopmental disorders such as CP, NMD, LM, or MS. Inclusion Criteria for Phase 1
Age between 2 and 17 years.
Consent from the participant or legal guardian to participate in the study.
Diagnosis of neurodevelopmental disorders such as CP, NMD, LM, or MS. Inclusion Criteria Related to the EXPLORER CLINICAL Device Characteristics
Medical authorization to stand upright and perform weight-bearing gait training.
Weight less than or equal to 60 kg.
Hip width less than or equal to 40 cm.
Distance from the hip joint center to the knee joint center: 21 cm - 36 cm.
Distance from the knee joint center to the ankle joint center: 20 - 35 cm.
EU shoe size less than or equal to 40.

Exclusion Criteria:

Any medical contraindication for standing or walking.
Presence of non-reducible contractures or heterotopic ossification above the degrees allowed by the device and/or outside the trajectory imposed by the device.
Spasticity (MAS) = 4 in lower limbs at the time of device use.
Structured hip and/or knee contracture greater than 20 degrees.
Inability to stand or walk with more than 5 degrees of hip abduction.
Inability to achieve 5 degrees of dorsal ankle flexion from the neutral position with or without orthosis.
Tibial leg length discrepancy that cannot be mitigated with the use of a foot wedge.
Skin alterations in areas of contact with the device.
History of fracture without trauma.
Presence of other conditions that cause exercise intolerance (such as uncontrolled hypertension, coronary artery diseases, arrhythmia, congestive heart failure, severe pulmonary disease).
Behavioral disorders that interfere with proper use of the device, such as impulsivity.
Allergy to any of the materials of the EXPLORER CLÍNICO: cotton, nylon, polyester, PPS, PEEK, or ABS. The materials used in EXPLORER CLÍNICO that were not previously used in ATLAS 2030, a medical device certified by the AEMPS, are PPS, PEEK, and ABS.