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Clinical Investigation to Validate the Safety and Performance of Integrating Functional Electrical Stimulation Into the ABLE Exoskeleton

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
therapy2people GmbH
RECRUITING
Vienna
Contact Information
Primary
Peter Lackner, Dr.
peter@tech2people.at
+43 681 207 41241
Time Frame
Start Date: 2026-04-20
Estimated Completion Date: 2026-08-12
Participants
Target number of participants: 15
Treatments
Experimental: Gait training with ABLE Exoskeleton + Functional Electrical Stimulation (ABLE FES)
Participants will undergo 8 rehabilitation sessions over 4-5 weeks using the ABLE Exoskeleton with Functional Electrical Stimulation integration (ABLE FES). Each session will last approximately 60 minutes and include donning/doffing, gait training, and functional assessments. Electrode placement and stimulation parameters will be adapted to the participant's pathology (spinal cord injury, acquired brain injury, or multiple sclerosis). Participants will also complete baseline, post-training, and follow-up assessments.
Related Therapeutic Areas
Sponsors
Leads: ABLE Human Motion S.L.
Collaborators: therapy2people GmbH

This content was sourced from clinicaltrials.gov