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

NCT07299734 | Recruiting Early Phase 1

• 1 other identifier: 25-5898
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cervical Spinal Cord Injury

Keywords

Cervical spinal cord injury; Augmented reality; Functional electrical stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Adherence

  During experimental sessions from week 1 to week 10.

• User feedback

  Discharge assessment at week 10.

Other Outcomes (2)

• Graded Redefined Assessment of Strength, Sensation and Prehension

  Baseline (week 0), discharge (week 10) and follow-up (week 14) assessments.

• Spinal Cord Independence Measure

  Baseline (week 0), discharge (week 10) and follow-up (week 14) assessments.

Study Arms (1)

Single group

EXPERIMENTAL

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

Interventions

AR + FES DEVICE

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.

Single group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Canadian Training Platform for Trials Leveraging Existing Networks: collaborator
• University Health Network, Toronto: lead

Study Sites (1)

Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, Canada

RECRUITING

Study Officials

• José Zariffa, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharmini Atputharaj, MSc

CONTACT

416-597-3422; Sharmini.Atputharaj@uhn.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)