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| Name | Class |
|---|---|
| Hospital Infantil Universitario Niño Jesús, Madrid, Spain | OTHER |
| Hospital Universitario La Paz | OTHER |
| Hospital Universitario 12 de Octubre | OTHER |
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The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.
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. Robotic devices are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER is a robotic device 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 in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.
A test phase will be conducted in order to make some final modifications and improve the device. Some participants of the sample will use the device in 1-3 occasions in a controlled environment.
After these modifications, participants will use the final version of the device in 8 different occasions in their homes and the community in order to prove its safety and usability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPLORER | Experimental | 8 sessions with the robotics gait device in their homes and natural environment for all participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPLORER | Device | 8 sessions of use of the device 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 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 |
| Spasticity | spasticity measured by the Modified Ashworth Scale (MAS), scored from 0 (no spasticity) to 4 (affected part in rigid flexion or extension) | through study completion, along 8 weeks |
| Heart rate | measurement of heart rate | through study completion, along 8 weeks |
| Oxygen saturation | measurement of Oxygen saturation when medical prescription | through study completion, along 8 weeks |
| Donning and doffing time |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 General Universitario Gregorio Marañon |
| OTHER |
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Time to don and doff the device to each participant |
| through study completion, along 8 weeks |
| Number of steps | Number of steps taken provided by the device | through study completion, along 8 weeks |
| Walking time | Walking time provided by the device | through study completion, along 8 weeks |
| Interventions of the investigators | The number 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 8 weeks |
| Participant satisfaction | Satisfaction of the participant (caregiver) with the device measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0. (QUEST 2.0), scored with a Likert type scale from 0 to 5, being 0 the lowest satisfaction and 5 the highest possible satisfaction with the device | at the end of the intervention, 8th week |
| Blood pressure | measurement of blood pressure | through study completion, along 8 weeks |
| through study completion, along 8 weeks |
| Accessibility of the house | Rate of the houses suitable to use the device | through study completion, along 8 weeks |
| Accessibility of the exterior spaces | Rate of the exterior spaces that are suitable to use the device | through study completion, along 8 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 |
| D009134 | Muscular Atrophy, Spinal |
| 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 |
| D013118 | Spinal Cord Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D009468 | Neuromuscular Diseases |
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