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

NCT ID: NCT07299734

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

AR + FES

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Training Platform for Trials Leveraging Existing Networks

UNKNOWN

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Zariffa, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Sharmini Atputharaj, MSc

Role: CONTACT

Phone: 416-597-3422

Email: Sharmini.Atputharaj@uhn.ca

Facility Contacts

Sharmini Atputharaj, MSc

Role: primary

Other Identifiers

25-5898

Identifier Type: -

Identifier Source: org_study_id