Actively Recruiting
Feasibility and Safety of a Combined Augmented Reality and Functional Electrical Stimulation System
Led by University Health Network, Toronto · Updated on 2025-12-23
7
Participants Needed
1
Research Sites
39 weeks
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
Cervical spinal cord injury (cSCI) can result in substantial loss of upper-limb function, with associated socio-economic impact on affected individuals and the healthcare system. Evidence suggests that non-invasive neuromodulation such as functional electrical stimulation (FES) therapy can contribute to regaining upper-limb function, which is a top priority for this population. This pilot study will involve individuals with cSCI using a device that combines augmented reality (AR) and functional electrical stimulation (FES) for 20, one-hour sessions over a 10-week period. The sessions will include upper-limb rehabilitation where individuals will interact with different objects with the aid of the AR +FES system. The primary objective is to assess safety and feasibility, measured by the absence of serious adverse events and participants' ability to independently set up and use the system. Secondary objectives include adherence to the intervention and user feedback through structured interviews. Exploratory outcomes will examine preliminary efficacy using clinical measures such as the Spinal Cord Independence Measure (SCIM) and the Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).
CONDITIONS
Official 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 between 5 and 25)
You will not qualify if you...
- Any disease or injury other than spinal cord injury affecting grasping performance
- Self-reported 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 that 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
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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
CONTACT
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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