Prediction of Muscle Responsiveness to FES Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Point-of-care Prediction of Muscle Responsiveness to Functional Electrical Stimulation Therapy During Neurorehabilitation (Sub-study)

Conditions
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Spinal Cord Injury Cervical

Intervention / Treatment
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* Device: Functional electrical stimulation therapy.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: This prognostic study examines how baseline measurements predict therapy response in a single group of participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional electrical stimulation therapy<br>Participants will receive 30 sessions of upper limb functional electrical stimulation therapy. Sessions will be 1 hour in length and take place 3-5 times per week. | Device: Functional electrical stimulation therapy.<br>* Functional electrical stimulation therapy will be delivered using the MyndMove system (MyndTec, Inc., Mississauga, Canada).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength recovery profile | Change over time in manual muscle testing conducted on each treated muscle. | Muscle strength assessed at each of 30 therapy sessions (3-5 sessions per week). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface electromyography signal features | 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. | Baseline (required). End of therapy (6-10 weeks; optional). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injury, Functional electrical stimulation, Upper limb, Electromyography, Prediction.