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

N/ANot Yet RecruitingNCT07159360

MarsiBionics60 enrolled

Overview

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 .

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuromuscular Disorders Neurodevelopmental Disorders

Interventions

CLINICAL EXPLORERDEVICE

8 sessions of use of the device in the rehabilitation center

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Asociación Pro Personas con Paralisis Cerebral (APAC-IAP)

Mexico City, Mexico City, Mexico

Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

Serious Adverse Events

occurrence of any serious adverse event to the participant or the caregiver

Time frame: through study completion, along 8 weeks

Falls prevalence

Number of falling events occurred from the participant or caregiver

Time frame: through study completion, along 8 weeks

Skin integrity

Occurrence of any injury of the skin in the areas of contact and produced by the use of the device

Time frame: through study completion, along 8 weeks

Pain (Visual Analogic Scale)

pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver, scored from 0 to 10, being 0 "no pain" and 10 "unbearable pain"

Time frame: through study completion, along 8 weeks

Heart rate

measurement of heart rate with a smart band

Time frame: through study completion, along 8 weeks

Oxygen saturation

measurement of Oxygen saturation with a smart band

Time frame: through study completion, along 8 weeks

Blood pressure

measurement of blood pressure with a smart band

Time frame: through study completion, along 8 weeks

Donning and doffing time

Time to don and doff the device to each participant

Time frame: through study completion, along 8 weeks

Central Contacts

Carlos Cumplido Trasmonte, Clinical Lead

CONTACT

+34918711900 carlos.cumplido@marsibionics.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Gait analysis

Spatiotemporal parameters will be done through photogrammetry.

Time frame: Day 1 and at the end of the intervention at 8 weeks

Range of motion

Passive Degree to which a joint can move (hip, knee, and ankle joints in both legs). From 0º to 180º.

Time frame: Day 1 and at the end of the intervention at 8 weeks

Quality of life (EQ-5D)

The EQ-5D is a standardized instrument used to measure and evaluate the quality of life. It assesses five key dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 3-level or 5-level scale, reflecting the severity of the condition (e.g., no problems, some problems, or extreme problems). The EQ-5D also includes a visual analogue scale (VAS) where individuals rate their overall health on a scale from 0 to 100. The tool is widely used in clinical trials, health surveys, and economic evaluations to assess health-related quality of life and make comparisons across different patient populations or interventions.

Time frame: Day 1 and at the end of the intervention at 8 weeks

Level of fatigue

Fatigue of both the participant and the therapist, Measured with the Borg scale

Time frame: through study completion, along 8 weeks

Level of Spasticity

Evaluation of spasticity with Modified Ahsworth Scale

Time frame: Day 1 and through study completion, along 8 weeks

Muscular activity (EMG)

EMG (Electromyography) is a technique that measures the electrical activity of muscles to assess their function. It helps detect neuromuscular disorders and evaluate muscle activation patterns, using either surface electrodes or needle inserts to record muscle activity. Measured with the system FREEEMG/BTS®.

Time frame: through study completion, along 8 weeks

Cerebral activity (EEG)

EEG (Electroencephalography) is a method used to record electrical activity in the brain. It involves placing electrodes on the scalp to measure brain wave patterns, helping to diagnose conditions like epilepsy, sleep disorders, and brain injuries. Measured with Enobio® EEG systems.

Time frame: through study completion, along 8 weeks

Acceptability

Analysis of the drop-out rate during the study period

Time frame: at the end of the intervention, 8th week

Accessibility of the participant

Rate of the participants suitable to use the device

Time frame: through study completion, along 8 weeks