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

Sponsor
ABLE Human Motion S.L.
Study ID
NCT07550699
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ABLE Exoskeleton with Functional Electrical Stimulation (ABLE FES) — DEVICE
    A robotic lower-limb exoskeleton integrated with functional electrical stimulation (ABLE FES) used for gait rehabilitation training.

Study Details

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.

Key Dates

First listed
Apr 24, 2026
Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Aug 12, 2026
Completion
Aug 12, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Number and type of device-related Adverse Events [ Time Frame: From baseline to follow-up (up to 2 weeks after end of intervention) ]

Central Contacts

Find similar trials

Nationwide
Multiple sclerosis trialsNeurology trialsBrain disorders trialsAutoimmune disease trials

Related Studies