Actively Recruiting
Assessing the Feasibility and Safety of a Combined Functional Electrical Stimulation and Augmented Reality System for Cervical Spinal Cord Injury
Led by University Health Network, Toronto · Updated on 2025-12-23
7
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
C
Canadian Training Platform for Trials Leveraging Existing Networks
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Feasibility and Safety of a Combined Augmented Reality and Functional Electrical Stimulation System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic cervical spinal cord injury
- Any level or severity of cervical spinal cord injury, traumatic or non-traumatic
- Ability to carry out object manipulations with visible impairment (GRASSP Prehension Performance sub-score 5-25)
You will not qualify if you...
- Any disease or injury other than spinal cord injury affecting grasping performance
- Contraindications to functional electrical stimulation such as pacemakers, implantable defibrillators, implanted neurostimulation devices, metallic implants in stimulated areas, cardiac conditions, epilepsy, uncontrolled seizures, wounds or fractures on the target limb
- Inability to understand the study procedures
- Muscles do not respond to functional electrical stimulation to produce grasping movements
- Currently participating in another upper limb rehabilitation intervention study (regular physical and occupational therapy allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants take part in experimental sessions using a combined augmented reality and functional electrical stimulation system to assist with object manipulation tasks.
20 sessions, 2 sessions per week
Duration - 4 weeks
Participants complete discharge and follow-up assessments to evaluate safety, feasibility, and user feedback after the experimental sessions.
1 discharge assessment and 1 follow-up assessment (one month after last session)
Trial Site Locations
Total: 1 location
1
Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, Canada
Actively Recruiting
Research Team
S
Sharmini Atputharaj, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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