An interventional study of EXPLORER in Cerebral Palsy, Acquired Brain Injury and Spinal Muscular Atrophy, sponsored by MarsiBionics. Completed at 5 sites in Spain. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by MarsiBionics · Not applicable, Interventional, and Treatment
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.
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's enrollment of 50 is above the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →MarsiBionics is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
8 sessions with the robotics gait device in their homes and natural environment for all participants
Device: EXPLORER
8 sessions of use of the device in the home and the community of the participants
Serious Adverse Events
occurrence of any serious adverse event to the participant or the caregiver
Time frame: through study completion, along 8 weeks
Falls prevalence
Number of falling events occurred from the participant or caregiver
Time frame: 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
Time frame: 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"
Time frame: 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)
Time frame: through study completion, along 8 weeks
Heart rate
measurement of heart rate
Time frame: through study completion, along 8 weeks
Oxygen saturation
measurement of Oxygen saturation when medical prescription
Time frame: through study completion, along 8 weeks
Donning and doffing time
Time to don and doff the device to each participant
Time frame: through study completion, along 8 weeks
Number of steps
Number of steps taken provided by the device
Time frame: through study completion, along 8 weeks
Walking time
Walking time provided by the device
Time frame: 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
Time frame: 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
Time frame: at the end of the intervention, 8th week
Blood pressure
measurement of blood pressure
Time frame: through study completion, along 8 weeks
Acceptability
Analysis of the drop-out rate during the study period
Time frame: at the end of the intervention, 8th week
Accessibility of the participant
Rate of the participants suitable to use the device
Time frame: through study completion, along 8 weeks
Accessibility of the house
Rate of the houses suitable to use the device
Time frame: through study completion, along 8 weeks
Accessibility of the exterior spaces
Rate of the exterior spaces that are suitable to use the device
Time frame: through study completion, along 8 weeks
Ran from Dec 2023 to primary completion in Aug 2024, 8 months.
Of 900 interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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