NCT06436898

Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke

Proof of Concept of Hybrid Robotics for Gait Rehabilitation of Persons Post-stroke (PoCH-Rehab)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Persons post-stroke suffer from hemiparesis affecting the functional abilities of the controlesional lower limb. Improving walking is therefore a primary rehabilitation goal for such patients. Robotic-Assisted Rehabilitation (RAR, e.g. exoskeletons) and Functional Electrical Stimulation (FES) are promising techniques to facilitate the functional recovery after stroke. allowing benefits to be maintained over long term.

Detailed description

Exoskeletons were originally developed for subjects with spinal cord injury where they demonstrated a positive impact on rehabilitation and relative costs. The investigators expect the same trend also for stroke. Based on prior exploratory activities using an overgorund exoskeleton (TWIN\_Acta) in gait rehabilitation post stroke, in this project the aim is to merge the potential of an overground exoskeleton and FES to treat the lower limb motor deficits in persons post-stroke, strengthening their residual abilities. Synchronized pairing of the two devices might boost the functional recovery of gait post-stroke by promoting neural reorganization The persons post stroke will undergo 20 gait rehabiliation sessions with the exoskeleton and with FES applied to the lower limb muscles during execution of gait with the aim of improving various gait and quality of life parameters. This experimental intervention will be compared to a control intervention using an exoskeleton alone for gait rehabiltation post stroke.

Conditions

• Stroke Sequelae
• Gait, Hemiplegic

Interventions

Type	Name	Description
DEVICE	Combined overground gait exoskeleton and FES applied to lower limb	Gait rehabilitation for persons with stroke, with an overground exoskeleton combined with an electromyographically controlled FES applied to lower limb muscles during gait.
DEVICE	Overground gait exoskeleton	Gait rehabilitation for persons with stroke, with an overground exoskeleton.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-07-01
• Completion: 2025-11-01
• First posted: 2024-05-31
• Last updated: 2024-05-31

Locations

1 site across 1 country: Italy