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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
Hospital Universitario Gregorio Marañón
Madrid, Spain
Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación
Madrid, Spain
Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Serious Adverse Events
occurrence of any serious adverse event to the participant or the caregiver
Time frame: through study completion, along 6 weeks
Falls prevalence
Number of falling events ocurred from the participant or caregiver
Time frame: 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
Time frame: through study completion, along 6 weeks
Pain (Visual Analogic Scale)
pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver
Time frame: through study completion, along 6 weeks
Spasticity
spasticity measured by the Modified Ashworth Scale (MAS)
Time frame: 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
Time frame: Once, during the first session with the exoskeleton
Donning and doffing time
Time to don and doff the device to each participant
Time frame: through study completion, along 6 weeks
Heart rate
measurement of heart rate when medical prescription
Time frame: through study completion, along 6 weeks
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Hospital Universitario La Paz
Madrid, Spain
Blood pressure
measurement of blood pressure when medical prescription
Time frame: through study completion, along 6 weeks
Oxygen saturation
measurement of Oxygen saturation when medical prescription
Time frame: 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.
Time frame: at the end of the intervention, 6th week
Number of steps
Number of steps taken with the exoskeleton provided by the device
Time frame: through study completion, along 6 weeks
Walking time
Walking time while using the exoskeleton provided by the device
Time frame: 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
Time frame: through study completion, along 6 weeks
Acceptability
Analysis of the drop-out rate during the study period
Time frame: At the end of the study, 6th week
Accesssibility of the participant
Rate of the participants suitable to use the device
Time frame: through study completion, along 6 weeks
Accesssibility of the house
Rate of the houses suitable to use the device
Time frame: through study completion, along 6 weeks
Accesssibility of the exterior spaces
Rate of the exterior spaces that are suitable to use the device
Time frame: through study completion, along 6 weeks