Actively Recruiting
Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton
Led by ABLE Human Motion S.L. · Updated on 2026-04-24
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
ABLE Human Motion S.L.
Lead Sponsor
T
therapy2people GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and clinical performance of the ABLE Exoskeleton integrated with Functional Electrical Stimulation (ABLE FES) in people with neurological conditions that affect walking. These conditions include spinal cord injury, acquired brain injury, and multiple sclerosis. The study also aims to gather initial information on possible clinical and psychosocial benefits of combining robotic assistance with electrical stimulation. Participants will receive 8 gait training sessions with the ABLE FES device, held twice weekly over 4 to 5 weeks. Each session lasts about 60 minutes and includes putting on and removing the device, walking training, and safety and performance checks. The placement of electrodes and stimulation settings will be customized based on the participant's neurological condition. Participants will undergo baseline, post-training, and follow-up assessments to monitor safety and performance. Researchers will measure device-related adverse events, walking distance, number of steps, time spent standing and walking, assistance needed, and gait characteristics. Vital signs will be checked before, during, and after sessions involving electrical stimulation. Additional evaluations include pain, muscle spasticity, user satisfaction, and tolerance to stimulation. The study duration is approximately 16 weeks, including training and follow-up visits.
CONDITIONS
Brief Title
Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- 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 as an inpatient or outpatient at the investigating center
- Ability to provide informed consent
You will not qualify if you...
- Significant osteoporosis increasing fracture risk
- Unresolved fractures in pelvis or limbs, or fragility fractures in lower limbs within past 2 years
- Spinal instability or use of spinal orthoses without medical approval
- Deterioration greater than 3 points in motor score of ISNCSCI in last 4 weeks
- Severe spasticity (Level 4 on Modified Ashworth Scale)
- Orthostatic hypotension preventing at least 10 minutes upright tolerance
- Uncontrolled autonomic dysreflexia
- Medical instability or unstable cardiovascular condition
- Untreated hypertension (SBP >140 mmHg, DBP >90 mmHg)
- Deep vein thrombosis or severe comorbidities deemed inappropriate by investigator
- Pressure ulcers Grade I or higher in areas contacting device
- Height outside 1.5-1.9 m range or weight over 100 kg
- Anatomical constraints incompatible with device use
- Range of motion restrictions preventing normal gait or sit-to-stand transitions
- Heterotopic ossification
- Pregnancy or breastfeeding
- Cognitive impairment preventing following study instructions
- Requires assisted ventilation
- Scoliosis over 40-50 degrees Cobb angle
- Presence of pacemakers, defibrillators, or non-compatible electronic implants
- Open wounds, infections, or active irritation at electrode placement sites
- Severe dermatological conditions in stimulation areas
- Uncontrolled active epilepsy
- Malignant tumors in area of application
- Severe loss of sensation where electrodes are placed
- Medical conditions contraindicating electrical stimulation
- Inability to communicate pain or adverse reactions during stimulation
- Venous thrombosis, thrombophlebitis, or severe arterial obstruction
- Chronic venous insufficiency with significant varicosities
- Hemophilia
- Ongoing infection or fever
- Metallic implants in flow area between electrodes
AI-Screening
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Your Study Journey
Duration - Up to 8 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Duration - Within 1 week after screening
Participants complete baseline assessments to measure initial health status before training.
1 baseline visit (in-person)
Duration - 4 to 5 weeks
Participants undergo 8 rehabilitation sessions over 4-5 weeks using the ABLE Exoskeleton integrated with Functional Electrical Stimulation. Each session lasts about 60 minutes and includes donning/doffing, gait training, and safety/performance assessments. Electrode placement and stimulation parameters are adapted to each participant's condition.
Twice weekly visits for 8 sessions (in-person)
Duration - Within 1 week after last training session
Participants complete assessments to evaluate safety, device performance, and clinical outcomes after finishing the training sessions.
1 post-training visit (in-person)
Duration - 2 weeks after post-training
Participants return for a follow-up visit 2 weeks after post-training assessment to record any adverse events since the end of training.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
therapy2people GmbH
Vienna, State of Vienna, Austria, 1220
Actively Recruiting
Research Team
P
Peter Lackner, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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