Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrica… (NCT07550699) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton
Austria15 participantsStarted 2026-04-20
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 de…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and type of device-related Adverse Events
Timeframe: From baseline to follow-up (up to 2 weeks after end of intervention)