Cervical Spinal Cord Injury
Conditions
Keywords
Cervical spinal cord injury, Augmented reality, Functional electrical stimulation, Neuromodulation
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).
Interventions
DEVICEAR + 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.
Sponsors
Canadian Training Platform for Trials Leveraging Existing Networks
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Set-up time | During experimental sessions from week 1 to week 10. | The study will track independence with the system by assessing set-up time. |
| Adverse events | Week 1 to week 14. | 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. |
| Feasibility - Assistance required. | During experimental sessions from week 1 to week 10. | The study will track independence with the system by assessing the number of times assistance is requested. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User feedback | Discharge assessment at week 10. | Structured and semi-structured interviews. |
| Adherence | During experimental sessions from week 1 to week 10. | Number of missed sessions. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Graded Redefined Assessment of Strength, Sensation and Prehension | Baseline (week 0), discharge (week 10) and follow-up (week 14) assessments. | Hand function assessment. |
| Spinal Cord Independence Measure | Baseline (week 0), discharge (week 10) and follow-up (week 14) assessments. | Questionnaire about independence on daily tasks. |
Countries
Canada
Contacts
Primary ContactSharmini Atputharaj, MSc
Outcome results
None listed