Spinal Cord Injury Cervical
Conditions
Keywords
Spinal cord injury, Functional electrical stimulation, Upper limb, Electromyography, Prediction.
Brief summary
Reduced arm and hand function has a significant impact on independence and quality of life after spinal cord injury. Functional electrical stimulation therapy (FES-T) is a treatment that can produce improvements in reaching and grasping function after neurological injuries. However, not all paralyzed muscles respond equally well to the therapy. Currently, therapists cannot predict which muscles will respond, limiting their ability to create a personalized therapy plan that can maximize outcomes while making the best use of the limited treatment time available. The objective of this study is to develop a diagnostic method that will allow therapists to quickly and easily screen muscles in the clinic, in order to predict how they will respond to FES-T. Participants with cervical spinal cord injury will receive FES-T through the Rocket Family Upper Extremity Clinic at the Toronto Rehabilitation Institute - University Health Network. Muscles receiving training will undergo a electrophysiological examination before the start of therapy, and will then be tracked for strength recovery over the course of 30 sessions. Lastly, signal processing and machine learning techniques will be applied to the electrophysiological data to predict the recovery profile of each muscle. The significance of this work will be to provide personalized therapy planning in FES-T, leading to more effective use of healthcare resource as well as improved outcomes.
Interventions
DEVICEFunctional electrical stimulation therapy.
Functional electrical stimulation therapy will be delivered using the MyndMove system (MyndTec, Inc., Mississauga, Canada).
Sponsors
Wings for Life
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This prognostic study examines how baseline measurements predict therapy response in a single group of participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cervical spinal cord injury * Paralysis or paresis in at least one upper extremity * At least 6 months post SCI * Able to understand and follow instructions * Able to tolerate being in a seated position for a least one hour required to deliver upper limb therapy * Willing to attend treatment sessions and all assessment sessions * Able to understand and provide informed consent * Male and female participants ≥ 18 years of age at the time of enrollment
Exclusion criteria
* Previous history of any other neuromuscular disorder or conditions that may affect motor response * Upper extremity injury or condition prior to SCI that limits the function of the hand or arm * In the judgment of the medical provider, the participant has medical complications that may interfere with the execution of the study * Currently enrolled in another upper limb study and/ or has received MyndMove Therapy within the past 3 months * Botulinum toxin injection into affected upper extremity and the muscle targeted by MyndMove® therapy within 3 months prior to the study start. No botulinum toxin injections in the upper extremity during the study treatment. * Females who are pregnant or planning to become pregnant in the duration of the trial * Regional disorder of the upper extremities such as fracture, dislocation, or joint contractures to less than 50% of the expected range of motion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength recovery profile | Muscle strength assessed at each of 30 therapy sessions (3-5 sessions per week). | Change over time in manual muscle testing conducted on each treated muscle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surface electromyography signal features | Baseline (required). End of therapy (6-10 weeks; optional). | Surface electromyography of treated muscles will be conducted at baseline. A set of signal features will be extracted for use in predictive modeling (examples include Hudgins' time-domain feature set, autoregressive coefficients, and frequency domain features). An optional second assessment will occur at the end of the 30 therapy sessions. |
Countries
Canada
Outcome results
None listed