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OpenTrials
Completed

NCT Number: NCT05462925

Prediction of Muscle Responsiveness to FES Therapy

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.

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Key information

Conditions

Spinal Cord Injury Cervical Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, M4G 3V9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional electrical stimulation therapy.

Device

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

Primary outcomes

  1. Muscle strength recovery profile

    Time frame: 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 outcomes

  1. Surface electromyography signal features

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Wings for Life

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2022
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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