Prediction of Muscle Responsiveness to FES Therapy

NCT05462925 | Completed

• 1 other identifier: 19-5395
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury Cervical

Keywords

Spinal cord injury; Functional electrical stimulation; Upper limb; Electromyography; Prediction.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Surface electromyography signal features

  Baseline (required). End of therapy (6-10 weeks; optional).

Study Arms (1)

Functional electrical stimulation therapy

EXPERIMENTAL

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.

Interventions

Functional electrical stimulation therapy. DEVICE

Functional electrical stimulation therapy will be delivered using the MyndMove system (MyndTec, Inc., Mississauga, Canada).

Functional electrical stimulation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Wings for Life: collaborator

Study Sites (1)

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, M4G 3V9, Canada

Location

Related Publications (1)

• Balbinot G, Li G, Chen A, Eftekhar P, Ma W, Kalsi-Ryan S, Zariffa J. Upper Extremity Muscle Recovery Profiles With Functional Electrical Stimulation Therapy in Chronic Spinal Cord Injury. Neuromodulation. 2025 Oct 16:S1094-7159(25)01026-8. doi: 10.1016/j.neurom.2025.08.416. Online ahead of print.

  PMID: 41099684 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• José Zariffa, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Sukhvinder Kalsi-Ryan, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This prognostic study examines how baseline measurements predict therapy response in a single group of participants.

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 18, 2022
• Study Start: July 20, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Once study has been published, the datasets corresponding to the analyses described will be shared upon request.
• Access Criteria: Data sharing will require completion of a data sharing agreement. Interested parties should contact the principal investigator.

Locations

CA (1)