Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulato… (NCT07062575) | Clinical Trial Compass
RecruitingNot Applicable
Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulatory Functions.
Netherlands10 participantsStarted 2025-06-19
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of the device
Timeframe: Through study completion (up to 16 weeks)
2
Performance of the device during the training period
Timeframe: Through the training period (up to 3 weeks) from training session 1-9
3
Performance of the device in the home/community period
Timeframe: Through the home/community period (up to 12 weeks)
4
Performance of the device in the home/community period
Timeframe: Through the home/community period (up to 12 weeks)
5
Performance of the device in the home/community period
Timeframe: Through the home/community period (up to 12 weeks)