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
16 weeks
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
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.
CONDITIONS
Official 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...
- 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
You will not qualify if you...
- 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 without medical approval
- Deterioration greater than 3 points in motor score of the ISNCSCI in the last 4 weeks
- Severe spasticity: Level 4 on the Modified Ashworth Scale
- Orthostatic hypotension preventing tolerance of 10 minutes upright
- Uncontrolled autonomic dysreflexia
- Medical instability or unstable cardiovascular condition
- Untreated hypertension (SBP > 140 mmHg, DBP > 90 mmHg)
- Deep vein thrombosis
- Severe comorbidities deemed inappropriate for study participation
- Pressure ulcers Grade I or higher in device contact areas
- 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
- Pregnant or breastfeeding women
- Cognitive impairment preventing following instructions
- Requires assisted ventilation
- Scoliosis with Cobb angle >40-50°
- Presence of pacemakers, defibrillators, or non-compatible electronic implants
- Open wounds, infections, or irritation at electrode sites
- Severe skin conditions in stimulation area
- Uncontrolled active epilepsy
- Malignant tumors in stimulation area
- Severe loss of sensation at electrode sites
- Medical contraindications to electrical stimulation
- Inability to communicate pain or discomfort during stimulation
- Venous thrombosis, thrombophlebitis, or severe arterial obstruction
- Chronic venous insufficiency with significant varicosities
- Hemophilia
- Ongoing infections or fever
- Metallic implants between electrode sites
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
therapy2people GmbH
Vienna, State of Vienna, Austria, 1220
Actively Recruiting
Research Team
P
Peter Lackner, Dr.
CONTACT
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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