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| Name | Class |
|---|---|
| Hospital Infantil Universitario Niño Jesús, Madrid, Spain | OTHER |
| Hospital General Universitario Gregorio Marañon | OTHER |
| Hospital Universitario La Paz | OTHER |
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Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk. EXPLORER is a robotic gait exoskeleton designed to rehabilitate children with motor disabilities in home and outdoor environments.
The aim of this study is to evaluate the efficacy and usability of EXPLORER in children with motor disability within their natural settings, including home and community environments.
Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk. 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 evaluate the efficacy and usability of EXPLORER in children with motor disability within their natural settings, including home and community environments.
An initial session will be conducted in the participant's natural environment, during which the researchers will instruct the primary caregivers on the use of the device. Subsequently, the device will be left for a two-month period for use in the natural settings deemed appropriate by the family.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPLORER | Experimental | Two-week period with the robotics gait device for use in the natural settings deemed appropriate by the family. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPLORER | Device | Two-week period with the robotics gait device for use in the natural settings deemed appropriate by the family. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | occurrence of any serious adverse event to the participant or the caregiver | through study completion, along 2 weeks |
| Falls prevalence | Number of falling events occurred from the participant or caregiver | through study completion, along 2 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 2 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 2 weeks |
| Donning and doffing time | Time to don and doff the device to each participant | through study completion, along 2 weeks |
| Device usage time | Time using the device | through study completion, along 2 weeks |
| Number of steps | number of steps with the device | through study completion, along 2 weeks |
| Usage modes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Rey Juan Carlos | Alcorcón | Madrid | 28922 | Spain | ||
| Hospital Universitario Gregorio Marañón |
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| Hospital Universitario 12 de Octubre |
| OTHER |
| Universidad Rey Juan Carlos | OTHER |
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two different usage modes (active and automatic).
| through study completion, along 2 weeks |
| Speed | speed achieved with the device (steps per minute) | through study completion, along 2 weeks |
| Device accessibility | Environments where the device has been used and level of accessibility in each environment measured with a 5 points Likert scale (0 not accessible - 5 very accessible) | through study completion, along 2 weeks |
| Range of motion | Passive Degree to which a joint can move (hip, knee, and ankle joints in both legs). From 0º to 180º. | Before starting the intervention (S1) and after completing the two weeks of use |
| Participation | Measured with the Child and Adolescent Scale of Participation. 20 ordinal scaled items across 4 subsections. Maximum total score is 80 (20 items x 4) and the minimum total score is 20 (20 items x 1) | Before starting the intervention (S1) and after completing the two weeks of use |
| Madrid |
| Madrid |
| 28007 |
| Spain |
| Hospital Infantil Universitario Niño Jesús - Servicio de Rehabilitación | Madrid | Madrid | 28009 | Spain |
| Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia | Madrid | Madrid | 28009 | Spain |
| Hospital Universitario 12 Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| 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 |
| 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 |
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