Spinal Cord Injury
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICEABLE Daily
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
Sponsors
ABLE Human Motion S.L.
Sint Maartenskliniek
Universitat Politècnica de Catalunya
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Height between 150-200 cm * Weight less than 100 kg * Capable of giving informed consent on their own * Able to train (at least) 3 days/week * Able to have at least 1 companion / buddy who can attend a minimum of two of the training sessions, besides the final assessment, and who will learn how to assist them at home and in the community (ideally two companions) * Proficiency in walking with the ABLE Exoskeleton * At least 8 weeks with minimal use (less than 5 sessions) of wearable robotic exoskeletons for gait assistance at the start of the study.
Exclusion criteria
* 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 * Disorders of the arms and hands that make walking with crutches impossible * Modified Ashworth Scale (MAS) \>3 in lower limbs * Cardiovascular health issues which prevent the participant from training * Instability to tolerate 10 minutes of standing without clinical symptoms of orthostatic hypotension * Psychological, cognitive issues, or any other condition that does not allow a participant to follow study procedures * Medically unstable due to severe comorbidities, including any condition that a physician deems inappropriate for completing study participation * Skin problems in areas that would be in contact with the device * Height, width, weight, or other anatomical limitations (such as differences in leg length) incompatible with the device * Insufficient joint range of motion (ROM) for the device * Known pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the device | Through study completion (up to 16 weeks) | 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 | Through the training period (up to 3 weeks) from training session 1-9 | The number and type of device errors or use errors during the training period. |
| Performance of the device in the home/community period | Through the home/community period (up to 12 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived health status | At baseline and the final assessment at end of the study (16 weeks) | 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) | After training period (3 weeks) and at the final assessment at the end of the study (16 weeks) | 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 | At the final assessment at the end of the study (16 weeks) | 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) | After training period (3 weeks) and at the final assessment at the end of the study (16 weeks) | 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. |
Countries
Netherlands
Contacts
CONTACTNoel Keijsers
CONTACTDaphne Oosterling
PRINCIPAL_INVESTIGATORNoel Keijsers
Sint Maartenskliniek
Outcome results
None listed