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New robotic suit aims to get spinal injury patients walking again at home

NCT ID NCT07062575

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a wearable robotic exoskeleton called ABLE Daily to see if it is safe and works well for helping people with spinal cord injury walk in their home and community. Ten participants will train with the device at a clinic for three weeks, then use it on their own at home for twelve weeks. The goal is to confirm the device can be used safely and effectively in everyday settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABLE Daily exoskeleton (a wearable robotic device that assists walking)
What this could lead to
If it works, this could provide a safe, practical way for people with spinal cord injury to walk more easily in daily life.
What could go wrong
This is a very small early study with only 10 participants, so results may not apply to everyone. The device may have errors or be hard to use, and there is a risk of falls or injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sint Maartenskliniek

    RECRUITING

    Hengstdal, Ubbergen, 6574NA, Netherlands

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