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 .
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.
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.
Single group
CLINICAL EXPLORER
Device8 sessions of use of the device in the rehabilitation center
Serious Adverse Events
occurrence of any serious adverse event to the participant or the caregiver
Falls prevalence
Number of falling events occurred from the participant or caregiver
Skin integrity
Occurrence of any injury of the skin in the areas of contact and produced by the use of the device
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"
Gait analysis
Spatiotemporal parameters will be done through photogrammetry.
Range of motion
Passive Degree to which a joint can move (hip, knee, and ankle joints in both legs). From 0º to 180º.
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.
Level of fatigue
Fatigue of both the participant and the therapist, Measured with the Borg scale
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MarsiBionics
Lead sponsor
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Collaborator
APAC, I.A.P.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
