Safety and Usability of the EXPLORER Exoskeleton in Adults With Neuromuscular Diseases
ConditionNeuromuscular Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMarsiBionics
About this trial
Neurodevelopmental disorders frequently result in abnormal development of the Central Nervous System (CNS), often leading to motor impairments such as difficulty in standing and walking. EXPLORER is a robotic exoskeleton for gait rehabilitation, specifically designed for adults aged 18 to 85 with motor disabilities.The aim of this study is to evaluate the safety and usability of the EXPLORER for adults with motor disability.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Weight < 100 kg.
Hip width between 30 - 45 cm.
Distance from the hip joint center to the knee joint center: 36 cm - 50 cm.
Distance from the knee joint center to the floor: 43.5 cm - 59.5 cm.
Disqualifiers
Spasticity (MAS) = 3 in lower limbs.
Skin alterations in the areas of contact with the device.
Planned surgical intervention during the study duration.
Two or more osteoporotic fractures in the lower limbs in the last 2 years.
Trial design
Design model
Single group
Treatments tested in this trial
Adults EXPLORER
DeviceTwo sessions with the robotic gait device in patients with neuromuscular diseases.
Treatment groups
7 Participants
are divided into 1 treatment groupGroup A: Adults EXPLORERExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Serious Adverse Events
Occurrence of any serious adverse event to the participant or the caregiver
Time frame
Through study completion, an average of 1 month2
Falls prevalence
Number of falling events occurred from the participant or caregiver
Time frame
Through study completion, an average of 1 month3
Heart Rate
Beats per minute
Time frame
Through study completion, an average of 1 month4
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, an average of 1 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
MarsiBionics
Lead sponsor
Hospital Universitario La Paz
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: