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New robotic suit with electric zaps aims to restore walking after brain or spinal injury

NCT ID NCT07550699

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This study is testing a robotic lower-limb exoskeleton combined with functional electrical stimulation (FES) to help people with conditions like spinal cord injury, brain injury, or multiple sclerosis improve their walking. The device provides robotic support and electrical stimulation to activate muscles during gait training. The trial will enroll 15 participants and focus on safety, ease of use, and basic performance measures like steps taken and distance walked.

What this could mean

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

Active substance
ABLE Exoskeleton with Functional Electrical Stimulation (ABLE FES)
What this could lead to
If successful, this device could offer a new way to improve walking ability and rehabilitation outcomes for people with neurological conditions.
What could go wrong
This is a very small early-stage study (15 people) focused on safety and performance, not proof of effectiveness. The device may not work for everyone or may cause discomfort.

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

14 people

The number who actually took part.

Started

Apr 2026

Finished

Sep 2026

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 to 80 years

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: * 18 to 80 years old * Diagnosis of acquired brain injury, spinal cord injury (neurological level between C5 and L2, AIS B to AIS D), or multiple sclerosis * Currently undergoing physiotherapy treatment, either as an inpatient or outpatient at the investigating center * Ability to provide informed consent Exclusion Criteria: * Significant osteoporosis that may increase the risk of fracture * Unresolved fractures in the pelvis or limbs, or a history of fragility fractures in the lower limbs within the past 2 years * Spinal instability (or use of spinal orthoses, unless medically approved) * Deterioration \>3 points of the total in the motor score of the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) in the last 4 weeks. Loss of sensation and/or motor activity above the level of injury detected that has not been evaluated by a doctor. * Severe spasticity: Level 4 on the Modified Ashworth Scale * Orthostatic hypotension: Inability to tolerate at least 10 minutes in an upright position * Uncontrolled autonomic dysreflexia * Medical instability * Unstable cardiovascular condition, hemodynamic instability, untreated hypertension (SBP \> 140 mmHg, DBP \> 90 mmHg), deep vein thrombosis (DVT), or uncontrolled autonomic dysreflexia * Severe comorbidities, including any condition deemed inappropriate by the investigator for using the ABLE Exoskeleton or for completing the study * Pressure ulcers Grade I or higher (as defined by the European Pressure Ulcer Advisory Panel - EPUAP) in areas that will be in contact with the device * Anthropometric measurements incompatible with the ABLE Exoskeleton, specifically height outside the 1.5-1.9 m range or weight exceeding 100 kg * Anatomical constraints (such as leg length differences, users unable to position themselves inside the device) that are incompatible with the device * Range of motion restrictions preventing normal gait or sit-to-stand transitions, including: Ankle: ability to achieve at least neutral (0°) position; Knee: ability to extend to at least -10°; Hip: bilateral hip flexion of at least 100° and extension of at least 0° * Heterotopic ossification * Pregnant or breastfeeding women * Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures * Requires assisted ventilation. * Scoliosis \>40-50º Cobb angle. * Presence of pacemakers, defibrillators, or other non-compatible electronic implants. * Open wounds, infections, or active irritation at the electrode placement sites. * Severe dermatological conditions in the stimulation area. * Uncontrolled active epilepsy. * Malignant tumors in the area of application. * Severe loss of sensation in the areas where electrodes are to be placed. * Medical conditions where electrical stimulation is contraindicated by physician recommendation. * Inability to communicate pain, discomfort, or adverse reactions during stimulation. * Venous thrombosis, thrombophlebitis, or severe arterial obstruction. * Chronic venous insufficiency with significant varicosities. * Hemophilia. * Ongoing infectious process or fever. * Presence of metallic implants in the flow area between the electrodes

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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.

Contacts and locations

Locations

  • therapy2people GmbH

    Vienna, State of Vienna, 1220, Austria

More trials for these conditions

Other studies related to the condition(s) this trial covers.