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

RecruitingEARLY Phase 1Ages 18 Years - 65 YearsAllUniversity Health Network, Toronto
NCT07299734 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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). Exclusion Criteria: * 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 * Currently participating in another upper limb rehabilitation intervention study (regular physical and occupational therapy is permitted).
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What it tests

  • AR + FES
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Where

1 site
Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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