New robotic suit with electric zaps aims to restore walking after brain or spinal injury
NCT ID NCT07550699
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
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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
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14 people
The number who actually took part.
- Started
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Apr 2026
- Finished
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Sep 2026
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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
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therapy2people GmbH
Vienna, State of Vienna, 1220, Austria
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