NCT07062575 Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulatory Functions.
| NCT ID | NCT07062575 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ABLE Human Motion S.L. |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-06-19 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-06-19 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Noel Keijsers
PRINCIPAL INVESTIGATOR
Sint Maartenskliniek
Frequently Asked Questions
Who can join the NCT07062575 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07062575 currently recruiting?
Yes, NCT07062575 is actively recruiting participants. Contact the research team at n.keijsers@maartenskliniek.nl for enrollment information.
Where is the NCT07062575 trial being conducted?
This trial is being conducted at Hengstdal, Netherlands.
Who is sponsoring the NCT07062575 clinical trial?
NCT07062575 is sponsored by ABLE Human Motion S.L.. The principal investigator is Noel Keijsers at Sint Maartenskliniek. The trial plans to enroll 10 participants.