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| Name | Class |
|---|---|
| National Research Council, Spain | OTHER_GOV |
| Hospital Infantil Universitario Niño Jesús, Madrid, Spain | OTHER |
| Hospital Universitario La Paz | OTHER |
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The goal of this clinical trial is to analyze the usability and safety of the prototype gait exoskeleton EXPLORE V2 in children with neurological and neuromuscular disease.
Participants will use the exoskeletons in their home and the community and variables regarding safety and usability will be measured and recorded.
Neurological and neuromuscular diseases are the main cause of motor disability in children, leading to the inability to stand and walk in many cases. Exoskeletons are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER V2 is a prototype of a robotic gait exoskeleton designed to assist gait in children with motor disability in their homes and the community. The aim of this study is to analyze the safety and usability of the EXPLORER V2 as a proof of concept.
A test phase will be conducted in healthy volunteers (phase 0) as a proof of concept with the aim of evaluating safety and usability in healthy participants prior to the use of the device in children with neurological and neuromuscular disease (phases 1 and 2). After this, participants will use the exoskeleton in 4 different ocassions, 1 in a laboratory of gait analysis and 3 in their homes and the community.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPLORER V2 | Experimental | 1 session with the exoskeleton EXPLORER V2 in healthy subjects 3 sessions with the exoskeleton EXPLORER V2 in subjects with disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPLORER V2 | Device | 4 sessions of use of the exoskeleton, 1 in a laboratory of gait analysis and 3 in the home and the community of the participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | occurrence of any serious adverse event to the participant or the caregiver | through study completion, along 6 weeks |
| Falls prevalence | Number of falling events ocurred from the participant or caregiver | through study completion, along 6 weeks |
| Skin integrity | Ocurrence of any injury of the skin in the areas of contact and produced by the use of the exoskeleton | through study completion, along 6 weeks |
| Pain (Visual Analogic Scale) | pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver | through study completion, along 6 weeks |
| Spasticity | spasticity measured by the Modified Ashworth Scale (MAS) | through study completion, along 6 weeks |
| Kinematic data during gait | Kinematic values for each joint of the lower limb during gait, assessed by photogrammetry in a gait analysis laboratory both in healthy subjects and participants with disease | Once, during the first session with the exoskeleton |
| Donning and doffing time | Time to don and doff the device to each participant | through study completion, along 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Analysis of the drop-out rate during the study period | At the end of the study, 6th week |
| Accesssibility of the participant | Rate of the participants suitable to use the device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga Arroyo Riaño | Hospital Universitario Gregorio Marañón | Principal Investigator |
| María Teresa Vara Arias | Hospital Infantil Universitario Niño Jesús | Principal Investigator |
| Ignacio Martínez Caballero | Hospital Infantil Universitario Niño Jesús | Principal Investigator |
| Sandra Espinosa García | Hospital Univsersitario La Paz | Principal Investigator |
| Sofía García de las Peñas | Hospital 12 de Octubre | Principal Investigator |
| Elena García Armada | National Research Council, Spain | Principal Investigator |
| Eva Barquín Santos | Marsi Bionics S L | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Gregorio Marañón | Madrid | 28007 | Spain | |||
| Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación |
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| Hospital Universitario 12 de Octubre |
| OTHER |
| Hospital General Universitario Gregorio Marañon | OTHER |
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| Heart rate |
measurement of heart rate when medical prescription |
| through study completion, along 6 weeks |
| Blood pressure | measurement of blood pressure when medical prescription | through study completion, along 6 weeks |
| Oxygen saturation | measurement of Oxygen saturation when medical prescription | through study completion, along 6 weeks |
| Participant satisfaction | Satisfaction of the participant (caregiver) with the devicem measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0. | at the end of the intervention, 6th week |
| Number of steps | Number of steps taken with the exoskeleton provided by the device | through study completion, along 6 weeks |
| Walking time | Walking time while using the exoskeleton provided by the device | through study completion, along 6 weeks |
| Interventions of the investigators | The amount of times that the investigators have to intervene in the session in order to avoid damage when the device is being used by the caregiver | through study completion, along 6 weeks |
| through study completion, along 6 weeks |
| Accesssibility of the house | Rate of the houses suitable to use the device | through study completion, along 6 weeks |
| Accesssibility of the exterior spaces | Rate of the exterior spaces that are suitable to use the device | through study completion, along 6 weeks |
| Madrid |
| 28009 |
| Spain |
| Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia | Madrid | 28009 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D001930 | Brain Injuries |
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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