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| Name | Class |
|---|---|
| Canadian Training Platform for Trials Leveraging Existing Networks | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharmini Atputharaj, MSc | Contact | 416-597-3422 | 6119 | Sharmini.Atputharaj@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| José Zariffa, PhD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network | Recruiting | Toronto | Ontario | Canada |
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.
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| Discharge assessment at week 10. |
Questionnaire about independence on daily tasks.
| Baseline (week 0), discharge (week 10) and follow-up (week 14) assessments. |