An interventional study of CLINICAL EXPLORER in Neuromuscular Disorders and Neurodevelopmental Disorders, sponsored by MarsiBionics. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by MarsiBionics · Not applicable, Interventional, and Treatment
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.
300 studies on the registry are indexed under Neuromuscular Diseases; 87 are open to participants now.
This study's planned enrollment of 60 is above the median of 32 across 168 interventional studies indexed under Neuromuscular Diseases.
Browse Neuromuscular Diseases studies →MarsiBionics is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
An initial assessment (screening visit), 8 intervention sessions (2 per week) in the rehabilitation center, and a final assessment.
Device: CLINICAL EXPLORER
8 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
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
QUEST
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
Time frame: at the end of the intervention at 8 weeks
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
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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