Clinical trial NCT05462925: Prediction of Muscle Responsiveness to FES Therapy
Official title: Point-of-care Prediction of Muscle Responsiveness to Functional Electrical Stimulation Therapy During Neurorehabilitation (sub-study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury Cervical
Keywords: Spinal cord injury
Functional electrical stimulation
Upper limb
Electromyography
Prediction.
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Wings for Life
First posted: 2022-07-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This prognostic study examines how baseline measurements predict therapy response in a single group of participants.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Muscle strength recovery profile
timeFrame: Muscle strength assessed at each of 30 therapy sessions (3-5 sessions per week).
Secondary outcomes:
measure: Surface electromyography signal features
timeFrame: Baseline (required). End of therapy (6-10 weeks; optional).
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute - University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: José Zariffa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Sukhvinder Kalsi-Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: