CLINICAL EXPLORER: 8 sessions of use of the device in the rehabilitation center
Study summary
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 .
Eligibility
Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Serious Adverse Events — through study completion, along 8 weeks occurrence of any serious adverse event to the participant or the caregiver
Falls prevalence — through study completion, along 8 weeks Number of falling events occurred from the participant or caregiver
Skin integrity — through study completion, along 8 weeks Occurrence of any injury of the skin in the areas of contact and produced by the use of the device
Pain (Visual Analogic Scale) — through study completion, along 8 weeks 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"
Heart rate — through study completion, along 8 weeks measurement of heart rate with a smart band
Oxygen saturation — through study completion, along 8 weeks measurement of Oxygen saturation with a smart band
Blood pressure — through study completion, along 8 weeks measurement of blood pressure with a smart band
Donning and doffing time — through study completion, along 8 weeks Time to don and doff the device to each participant
QUEST — at the end of the intervention at 8 weeks Using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) questionnaire administered to the participants' caregivers at the end of the intervention. The QUEST 2.0 scale has 12 items. Each item is rated on a 5-point Likert scale
Trial sites (2)
Facility
City
Region
Status
Asociación Pro Personas con Paralisis Cerebral (APAC-IAP)
Mexico City
Mexico City
Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia
Madrid
Madrid
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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