The goal of this clinical trial is to to confirm the safety and performance of the ABLE Daily to perform ambulatory functions in home and community settings for people with spinal cord injury.
The experimental period will cover the training period with the ABLE Daily exoskeleton (3 weeks of use at the investigational site with a total of 9 sessions) and the home period (12 weeks of personal use at home and community environments).
At least 18 years old
Chronic SCI (>6 months)
Injury at levels T1 to L5 (AIS A to D)
Walking Index for Spinal Cord Injury (WISCI) score 0 until 9
High risk of fractures due to osteoporosis, a dual energy X-ray absorptiometry (DEXA)-scan at the hip, distal femur, and proximal tibia BMD score
Fragility fractures of the lower limbs in the last 2 years
Deterioration >3 in the International Standards for Neurological Classification of SCI (ISNCSCI) score in the last 4 weeks
Spinal instability, like spondylolisthesis
Single group
ABLE Daily
DeviceThe participants will receive training sessions with the ABLE Daily at Sint Maartenskliniek. After they pass the skills and knowledge exam, they will receive the ABLE Daily at their disposal at home for twelve weeks
Safety of the device
The total number of adverse events and serious adverse events related to the investigational device at the end of the study will be measured.
Performance of the device during the training period
The number and type of device errors or use errors during the training period.
Performance of the device in the home/community period
The amount of use of the device during the home/community use period, as measured by the number of sessions and the walking time, number of steps, and distance walked per session.
Performance of the device in the home/community period
The usability of the device as measured by the purpose and location of use of the device during the home/community use period which will be registered in a logbook by the participant.
Perceived health status
The change from baseline to final assessment of the overall perceived health status of the participants, as measured by the scores of the 36-Item Short Form Survey Instrument (SF-36). Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high Quality of Life. Lower scores indicate more disability, while higher scores indicate less disability.
Gait performance while using the device (6MWT)
The change from the Community Skills Test to the final exoskeleton assessment of the 6-Minute Walk Test (6MWT). The outcome will be the distance walked during the 6 minutes after the training period and once again after the home period.
User satisfaction
The general user satisfaction of participants, companions, and therapists at the end of the study, as measured by the scores of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0). 12 item instrument used to assess satisfaction with a specific assistive device; eight of these items assess characteristics of that assistive device and the remaining four items assess service and include: 1. Service delivery 2. Repairs and service of the device 3. Professionalism of service 4. Follow-up service Participants are asked to rate their satisfaction for the device on a five point scale that ranges from "not satisfied" at all to "very satisfied." Finally, participants are asked to choose the three most important items related to the assistive device in question System Usability Scale (SUS) to measure the perceived usability of the device. The scales value from 0 to 4 (with four being the most positive response).
Gait performance using the device: 10-Meter Walk Test (10MWT)
The 10 meter walk test will be used to compare performance after the training period and once again after the home period to monitor any changes in speed.
Cardiovascular health
Blood draw test to check levels of high-density lipoprotein cholesterol (HDL-c), Low-Density Lipoprotein Cholesterol (LDL-c), Triglyceride (TG), and Total Cholesterol (TC). Improvement is indicated with lower values of LDL-c and lower Triglycerides
Respiratory Parameters
Spirometry to assess the force vital capacity (FVC). FVC is crucial for evaluating lung function and respiratory and global health. Improvement indicates higher values of FVC.
Spasticity
Visual analog scale (VAS) is a self-report tool that allows individuals to rate their perceived level of spasticity on a continuous scale, typically ranging from 0 to 10, where higher scores indicate greater severity. Spasticity is a complex phenomenon that can vary greatly in intensity and impact from person to person. The VAS provides a means for individuals to subjectively quantify and communicate their experience of spasticity, capturing nuances that may not be fully captured by objective measures alone. 0 indicated no spasticity and 10 indicates the most spasticity experienced.
Bowel and bladder management (SCI-QOL)
Bladder Management Difficulties and Bowel Management Difficulties items from the Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire. The SCI-QOL questionnaire is a validated measure specifically designed to assess the quality of life in individuals with SCI across various domains, including bladder and bowel function
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ABLE Human Motion S.L.
Lead sponsor
Sint Maartenskliniek
Collaborator
Universitat Politècnica de Catalunya
Collaborator
