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Enrolling By Invitation
NCT05643313
Clinical Investigation on Feasibility and Usability of the ABLE Exoskeleton Device for Individuals With Spinal Cord Injury to Perform Skills for Home and Community Environments
Conditions: Spinal Cord Injuries
Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 10
Sponsor: ABLE Human Motion S.L.
Location: Germany
Summary
The loss of the ability to walk and the associated restriction of mobility presents a major challenge to people with spinal cord injury in an everyday environment designed for pedestrians.
Exoskeletal technology has the potential to help people with impaired leg function to regain ambulation and thus improve their independence.
This technology is not completely new, but due to their high access price (~120k€/unit), high size and weight (~25 kg), and need for trained physiotherapist supervision, commercially available exoskeletons are only found in large hospitals and only in very few cases get into patients' homes.The company ABLE Human Motion S.L. (Barcelona, Spain) has developed a novel exoskeleton to overcome these disadvantages, which is more compact, lighter and easier to use.The primary objective of this study is to determine the feasibility and usability of the ABLE Exoskeleton for persons with SCI to perform skills in home and community environments.
Eligibility Criteria
Participants will be taken from former or current patients at one of the two SCI centres.Inclusion Criteria:18 to 70 years of ageTraumatic and non-traumatic SCIMotor incomplete SCI with Neurological Level of Injury (NLI) C5-L5, or, Motor Complete SCI with NLI T1-L5Time since onset of SCI > 6 monthsAbility to give informed consentExclusion Criteria:WISCI II without exoskeleton of >135 or more risk factors present for fragility as stated by Craven et al (Craven et al., 2009a).History of lower limb fragility fractures in the last 2 yearsDeterioration > 3 points of the total ISNCSCI motor score within the last 4 weeksSpinal instabilityModified Ashworth scale 4 in lower limbsUnable to tolerate 30 min standing without clinical symptoms of orthostatic hypotensionUnable to perform a sit-to-stand transfer or stand in the device with assistancePsychological or cognitive issues that do not allow the participant to follow the study proceduresKnown pregnancy or breastfeedingAny neurological condition other than SCIMedically unstable - Unstable cardiovascular system, hemodynamic instability, untreated hypertension (Systolic blood pressure > 140, Diastolic blood pressure > 90 mmHg), unresolved DVT, uncontrolled autonomic dysreflexia.Severe comorbidities - Any condition that a physician considers to not be appropriate to complete participation in the study.Ongoing skin issues - Grade I or higher on EPUAP on areas that will be in contact with exoskeleton (European Pressure Ulcer Advisory Panel, 2019)Height, width, weight or other anatomical constraints (such as leg length differences) incompatible with the deviceRange of motion (ROM) restrictions in lower extremities, that are incompatible with the device
Source: ClinicalTrials.gov (NCT05643313). StuddyBuddy aggregates publicly available trial information.
