AR + FES for Broken Neck

Overseen By Sharmini Atputharaj, MSc

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University Health Network, Toronto

Disqualifiers: Other diseases, FES contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 23

Duration: 10 weeks

7 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

José Zariffa, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for individuals who have suffered a broken neck, specifically cervical spinal cord injury (cSCI), and are looking to improve their upper-limb function. Participants should be able to commit to 20 sessions over 10 weeks and use the AR + FES system independently.

Inclusion Criteria

I have a long-term spinal cord injury in my neck.

I have a spinal cord injury in my neck, regardless of how severe or how it happened.

I can use my hands but with some difficulty.

Exclusion Criteria

I have no other conditions affecting my ability to grasp.

My muscles can't make grasping movements with electrical stimulation.

I am not in another upper limb study but may be doing regular therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 session

1 visit (in-person)

Treatment

Participants undergo 20 experimental sessions using the AR + FES system for upper-limb rehabilitation

10 weeks

20 visits (in-person)

Discharge Assessment

Participants complete a discharge assessment including user feedback and clinical measures

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up assessments

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AR + FES

Trial Overview

The study tests a new device combining augmented reality (AR) with functional electrical stimulation (FES) during rehabilitation exercises. It aims to determine if it's safe and feasible for people with cSCI to use, by monitoring any serious adverse events and participants' ability to operate the system.

How Is the Trial Designed?

Group I: Single group Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Canadian Training Platform for Trials Leveraging Existing Networks

Collaborator