Safety and Feasibility Study of a Device Combining Augmented Reality and Functional Electrical Stimulation for Upper-Limb Rehabilitation in Adults with Cervical Spinal Cord Injury

What this Trial Is About

This research aims to evaluate the safety and feasibility of a combined augmented reality AR and functional electrical stimulation FES system for people with cervical spinal cord injury cSCI, a condition that often causes significant loss of upper-limb function. The study focuses on how this non-invasive neuromodulation therapy may help regain arm and hand use, which is a top priority for affected individuals. It is an early phase pilot study conducted by the University Health Network, Toronto. Participants will use the AR FES device during twenty one-hour sessions spread over ten weeks, with two sessions per week. The device includes an AR headset and electrodes placed on specific hand muscles, allowing users to interact with objects while the system tracks hand posture and adjusts electrical stimulation to assist movement. After the treatment period, there is a discharge assessment and a follow-up evaluation one month later. During the study, researchers will monitor safety by tracking adverse events over 14 weeks and assess how easily participants can set up and use the system independently during the treatment sessions. They will also evaluate adherence to the therapy and gather user feedback through interviews at discharge. Exploratory measures will include clinical assessments of upper-limb function and independence such as the Spinal Cord Independence Measure SCIM and the GRASSP test. Overall participation spans approximately 14 weeks.

Feasibility and Safety of a Combined Augmented Reality and Functional Electrical Stimulation System