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).
Chronic cervical SCI
Any level or severity of cervical SCI, traumatic or non-traumatic
Can carry out object manipulations but with visible impairment (i.e., 5-25 on the GRASSP Prehension Performance sub-score).
Any disease or injury other than the SCI that may be affecting grasping performance.
Individuals with any self-reported FES contraindications (pacemakers, implantable defibrillator, implanted neurostimulation device, metallic implants in the 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 FES to produce grasping movements
Single group
AR + FES
DeviceWithin each one-hour experimental session, participants will interact with different objects (e.g. block, credit card, marble). They will be wearing an augmented reality (AR) headset and electrodes will be placed over finger flexors, thumb flexors and finger extensors muscles. The AR headset will track hand posture and use the difference between the actual posture and a target posture to regulate functional electrical stimulation (FES) delivered via the electrodes.
Adverse events
Presence of adverse and serious adverse events. These will be recorded during each session. The criterion for success is no study-related serious adverse events and no study-related adverse events that cannot be alleviated by stopping electrical stimulation.
Feasibility - Set-up time
The study will track independence with the system by assessing set-up time.
Feasibility - Assistance required.
The study will track independence with the system by assessing the number of times assistance is requested.
Adherence
Number of missed sessions.
User feedback
Structured and semi-structured interviews.
Graded Redefined Assessment of Strength, Sensation and Prehension
Hand function assessment.
Spinal Cord Independence Measure
Questionnaire about independence on daily tasks.
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University Health Network, Toronto
Lead sponsor
Canadian Training Platform for Trials Leveraging Existing Networks
Collaborator
