NCT07550699 Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton
| NCT ID | NCT07550699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ABLE Human Motion S.L. |
| Condition | Acquired Brain Injury (Including Stroke) |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2026-08-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 15 participants in total. It began in 2026-04-20 with a primary completion date of 2026-08-12.
⚠ 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 primary objective of this study is to validate the safety and clinical performance of the ABLE Exoskeleton with integrated Functional Electrical Stimulation (ABLE FES) in individuals with neurological conditions that impair gait, including spinal cord injury, acquired brain injury, and multiple sclerosis. The secondary objective is to collect preliminary data on the potential clinical and psychosocial benefits of combining robotic gait assistance with electrical stimulation.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07550699 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acquired Brain Injury (Including Stroke). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07550699 currently recruiting?
Yes, NCT07550699 is actively recruiting participants. Contact the research team at peter@tech2people.at for enrollment information.
Where is the NCT07550699 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT07550699 clinical trial?
NCT07550699 is sponsored by ABLE Human Motion S.L.. The trial plans to enroll 15 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.