Prediction of Muscle Responsiveness to FES Therapy

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Cord Injury Cervical
• Intervention / Treatment: Device: Functional electrical stimulation therapy.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharmini Atputharaj; Phone Number: 6119 1-416-597-3422; Email: Sharmini.Atputharaj@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 3V9
      • Toronto Rehabilitation Institute - University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional electrical stimulation therapy; 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.; Functional electrical stimulation therapy will be delivered using the MyndMove system (MyndTec, Inc., Mississauga, Canada).

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Wings for Life
• Investigators: Principal Investigator: José Zariffa, PhD, University Health Network, Toronto; Principal Investigator: Sukhvinder Kalsi-Ryan, PhD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Upper limb; Electromyography; Spinal cord injury; Functional electrical stimulation; Prediction.
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 19-5395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data may be shared following study completion upon reasonable request to the investigators and completion of a data sharing agreement.
• IPD Sharing Time Frame: Once study has been published, the datasets corresponding to the analyses described will be shared upon request.
• IPD Sharing Access Criteria: Data sharing will require completion of a data sharing agreement. Interested parties should contact the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No