Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CLINICAL EXPLORER.
- Who it may be relevant to
- Registry conditions: Neuromuscular Disorders, Neurodevelopmental Disorders. Basic parameters: 2 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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 .
Detailed 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.
Interventions
- Device CLINICAL EXPLORER
8 sessions of use of the device in the rehabilitation center
Primary outcome measures
- Serious Adverse Events [Time frame: through study completion, along 8 weeks]
- Falls prevalence [Time frame: through study completion, along 8 weeks]
- Skin integrity [Time frame: through study completion, along 8 weeks]
- Pain (Visual Analogic Scale) [Time frame: through study completion, along 8 weeks]
- Heart rate [Time frame: through study completion, along 8 weeks]
- Oxygen saturation [Time frame: through study completion, along 8 weeks]
- Blood pressure [Time frame: through study completion, along 8 weeks]
- Donning and doffing time [Time frame: through study completion, along 8 weeks]
- QUEST [Time frame: at the end of the intervention at 8 weeks]
Secondary outcome measures (9)
- Gait analysis [Time frame: Day 1 and at the end of the intervention at 8 weeks]
- Range of motion [Time frame: Day 1 and at the end of the intervention at 8 weeks]
- Quality of life (EQ-5D) [Time frame: Day 1 and at the end of the intervention at 8 weeks]
- Level of fatigue [Time frame: through study completion, along 8 weeks]
- Level of Spasticity [Time frame: Day 1 and through study completion, along 8 weeks]
- Muscular activity (EMG) [Time frame: through study completion, along 8 weeks]
- Cerebral activity (EEG) [Time frame: through study completion, along 8 weeks]
- Acceptability [Time frame: at the end of the intervention, 8th week]
- Accessibility of the participant [Time frame: through study completion, along 8 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- Asociación Pro Personas con Paralisis Cerebral (APAC-IAP) — Mexico City
Spain · 1 center
- Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia — Madrid
Identifiers
NCT: NCT07159360 · EXC