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

Assessing the Feasibility and Safety of a Combined Closed Loop Functional Electrical Stimulation and Augmented Reality System for Individuals With Cervical Spinal Cord Injury

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).

Study Overview

• Status: Recruiting
• Conditions: Cervical Spinal Cord Injury
• Intervention / Treatment: Device: AR + FES

• Study Type: Interventional
• Enrollment (Estimated): 7
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Sharmini Atputharaj, MSc; Phone Number: 6119 416-597-3422; Email: Sharmini.Atputharaj@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network
      • Contact: Sharmini Atputharaj, MSc; Phone Number: 6119 416-597-3422; Email: Sharmini.Atputharaj@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single group; Participants will go through 1 screening session, 20 experimental sessions (2 sessions per week for 10 weeks), 1 discharge assessment, and 1 follow up assessment (one month after the last experimental session).

Device: AR + FES; Within 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 1 to week 14.
Feasibility - Set-up time	The study will track independence with the system by assessing set-up time.	During experimental sessions from week 1 to week 10.
Feasibility - Assistance required.	The study will track independence with the system by assessing the number of times assistance is requested.	During experimental sessions from week 1 to week 10.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Number of missed sessions.	During experimental sessions from week 1 to week 10.
User feedback	Structured and semi-structured interviews.	Discharge assessment at week 10.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graded Redefined Assessment of Strength, Sensation and Prehension	Hand function assessment.	Baseline (week 0), discharge (week 10) and follow-up (week 14) assessments.
Spinal Cord Independence Measure	Questionnaire about independence on daily tasks.	Baseline (week 0), discharge (week 10) and follow-up (week 14) assessments.

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Canadian Training Platform for Trials Leveraging Existing Networks
• Investigators: Principal Investigator: José Zariffa, PhD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Neuromodulation; Augmented reality; Functional electrical stimulation; Cervical spinal cord injury
• Other Study ID Numbers: 25-5898

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified coded study data may be used or shared with other researchers for future studies. Directly identifying information will be replaced by a number, which will be applied to the study data. The participant key matching the code to the participant will be kept by the UHN study team. This may include storing the coded study data in controlled-access databases or open access, publicly accessible databases.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No