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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Two-week period with the robotics gait device for use in the natural settings deemed appropriate by the family.
Universidad Rey Juan Carlos
Alcorcón, Madrid, Spain
Hospital Universitario Gregorio Marañón
Madrid, Madrid, Spain
Hospital Infantil Universitario Niño Jesús - Servicio de Rehabilitación
Madrid, Madrid, Spain
Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia
Madrid, Madrid, Spain
Hospital Universitario 12 Octubre
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Serious Adverse Events
occurrence of any serious adverse event to the participant or the caregiver
Time frame: through study completion, along 2 weeks
Falls prevalence
Number of falling events occurred from the participant or caregiver
Time frame: 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
Time frame: 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"
Time frame: through study completion, along 2 weeks
Donning and doffing time
Time to don and doff the device to each participant
Time frame: through study completion, along 2 weeks
Device usage time
Time using the device
Time frame: through study completion, along 2 weeks
Number of steps
number of steps with the device
Time frame: through study completion, along 2 weeks
Usage modes
two different usage modes (active and automatic).
Time frame: through study completion, along 2 weeks
Speed
speed achieved with the device (steps per minute)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: Before starting the intervention (S1) and after completing the two weeks of use
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
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