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| Name | Class |
|---|---|
| Hospital Infantil Universitario Niño Jesús, Madrid, Spain | OTHER |
| APAC, I.A.P. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLINICAL EXPLORER | Experimental | An initial assessment (screening visit), 8 intervention sessions (2 per week) in the rehabilitation center, and a final assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLINICAL EXPLORER | Device | 8 sessions of use of the device in the rehabilitation center |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | occurrence of any serious adverse event to the participant or the caregiver | through study completion, along 8 weeks |
| Falls prevalence | Number of falling events occurred from the participant or caregiver | 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 | 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" | through study completion, along 8 weeks |
| Heart rate | measurement of heart rate with a smart band | through study completion, along 8 weeks |
| Oxygen saturation | measurement of Oxygen saturation with a smart band | through study completion, along 8 weeks |
| Blood pressure | measurement of blood pressure with a smart band | through study completion, along 8 weeks |
| Donning and doffing time |
| Measure | Description | Time Frame |
|---|---|---|
| Gait analysis | Spatiotemporal parameters will be done through photogrammetry. | 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. |
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Inclusion Criteria for Phase 0
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Cumplido Trasmonte, Clinical Lead | Contact | +34918711900 | carlos.cumplido@marsibionics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Pro Personas con Paralisis Cerebral (APAC-IAP) | Mexico City | Mexico City | 06720 | Mexico |
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| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D065886 | Neurodevelopmental Disorders |
| D002547 | Cerebral Palsy |
| D001930 | Brain Injuries |
| D009134 | Muscular Atrophy, Spinal |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
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Time to don and doff the device to each participant
| 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 | at the end of the intervention at 8 weeks |
| 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. | 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 | through study completion, along 8 weeks |
| Level of Spasticity | Evaluation of spasticity with Modified Ahsworth Scale | 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®. | 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. | through study completion, along 8 weeks |
| Acceptability | Analysis of the drop-out rate during the study period | at the end of the intervention, 8th week |
| Accessibility of the participant | Rate of the participants suitable to use the device | through study completion, along 8 weeks |
| Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia | Madrid | Madrid | 28009 | Spain |
|
| D002493 |
| Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013118 | Spinal Cord Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |