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).
The ABLE Daily Exoskeleton is a wearable powered lower-limb exoskeleton that actively assists individuals with spinal cord injury to stand up, walk, ascend and descend a ramp of 5 degrees and sit down. The device consists of a rigid brace that attaches to the torso, legs and feet of the user via straps and supports. It is a bilateral robotic exoskeleton with four battery-powered motors that drive the knee and hip joints assisting in flexion-extension. The other degrees of freedom of the hip and knee joints are restricted. The ankle joint of the exoskeleton is passively articulated with a spring within a limited range of motion. The experimental period will cover the training period happening at the investigational site where the participants and their companions will be trained 3 times a week. They will then have to perform a community skills test, if passed they will be allowed to take the exoskeleton home and use it in their daily life for 12 weeks. Pre and post assessments will be made.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
The 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
Sint Maartenskliniek
Hengstdal, Ubbergen, Netherlands
RECRUITINGSafety 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.
Time frame: Through study completion (up to 16 weeks)
Performance of the device during the training period
The number and type of device errors or use errors during the training period.
Time frame: Through the training period (up to 3 weeks) from training session 1-9
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.
Time frame: Through the home/community period (up to 12 weeks)
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.
Time frame: Through the home/community period (up to 12 weeks)
Performance of the device in the home/community period
The number and type of device errors at the end of the home/community use period will be registered.
Time frame: Through the home/community period (up to 12 weeks)
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.
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Time frame: At baseline and the final assessment at end of the study (16 weeks)
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.
Time frame: After training period (3 weeks) and at the final assessment at the end of the study (16 weeks)
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).
Time frame: At the final assessment at the end of the study (16 weeks)
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.
Time frame: After training period (3 weeks) and at the final assessment at the end of the study (16 weeks)