Spinal Cord InjuryNCT07062575
Exoskeleton Training at Home to Assist Participants With Spinal Cord Injuries to Perform Ambulatory Functions.
A study testing ABLE Daily in people with Spinal Cord Injury, run by ABLE Human Motion S.L. at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- ABLE Daily
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Jun 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Daphne Oosterling contact
Netherlands1 site, 1 recruiting
- Recruiting
Sint Maartenskliniek
Hengstdal, Ubbergen, 6574NA
Noël Keijsers, +31 6 44244217, n.keijsers@maartenskliniek.nl
About this study
Official title: Clinical Investigation on the Safety and Performance of the ABLE Daily to Assist People With Spinal Cord Injury in Performing Ambulatory Functions in Home and Community Settings
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).
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- ABLE Daily
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABLE DailyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention with exoskeleton | Experimental | 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. Receives: Device: ABLE Daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through the home/community period (up to 12 weeks)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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:
- Service delivery
- Repairs and service of the device
- Professionalism of service
- 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).
Measured: 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.
Measured: After training period (3 weeks) and at the final assessment at the end of the study (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start19 Jun 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ABLE Human Motion S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sint Maartenskliniek, Universitat Politècnica de Catalunya
- Responsible party
- Sponsor
- Investigators
- Noel Keijsers, Principal investigator, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062575
- Sponsor's protocol ID
- ABLEdailySCI
- Other IDs
- CIV-25-01-050614
- Status last verified
- Jun 2026
- First submitted
- 26 May 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation on the Safety and Performance of the ABLE Daily to Assist People With Spinal Cord Injury in Performing Ambulatory Functions in Home and Community Settings
- ClinicalTrials.gov ID
- NCT07062575
- Acronym / sponsor ID
- ABLEdailySCI
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ABLE Human Motion S.L.Industry (pharma, biotech, devices)
- Collaborators
- Sint Maartenskliniek, Universitat Politècnica de Catalunya
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention with exoskeleton | Experimental | Device: ABLE DailyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABLE DailyThe 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 | Device | Intervention with exoskeleton |
Primary outcome
Safety of the device
Time frame: 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
Time frame: 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
Time frame: 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.
Performance of the device in the home/community period
Time frame: Through the home/community period (up to 12 weeks)
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.
Performance of the device in the home/community period
Time frame: Through the home/community period (up to 12 weeks)
The number and type of device errors at the end of the home/community use period will be registered.
4 secondary outcomes
Perceived health status
Time frame: At baseline and the final assessment at end of the study (16 weeks)
Gait performance while using the device (6MWT)
Time frame: After training period (3 weeks) and at the final assessment at the end of the study (16 weeks)
User satisfaction
Time frame: At the final assessment at the end of the study (16 weeks)
Gait performance using the device: 10-Meter Walk Test (10MWT)
Time frame: After training period (3 weeks) and at the final assessment at the end of the study (16 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daphne Oosterling contact
Noel Keijsers principal investigator
Sint Maartenskliniek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABLE Daily in people with Spinal Cord Injury, run by ABLE Human Motion S.L. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noel Keijsers (+ 31 6 44244217, n.keijsers@maartenskliniek.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the device (time frame: Through study completion (up to 16 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.