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Prediction of Muscle Responsiveness to FES Therapy

Primary Purpose

Spinal Cord Injury Cervical

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Functional electrical stimulation therapy.

About this trial

This is an interventional other trial for Spinal Cord Injury Cervical focused on measuring Spinal cord injury, Functional electrical stimulation, Upper limb, Electromyography, Prediction.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Toronto Rehabilitation Institute - University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Functional electrical stimulation therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Muscle strength recovery profile

Change over time in manual muscle testing conducted on each treated muscle.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05462925

First Posted

July 4, 2022

Last Updated

July 21, 2022

Sponsor

University Health Network, Toronto

Collaborators

Wings for Life

1. Study Identification

Unique Protocol Identification Number

NCT05462925

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 20, 2022 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

Collaborators

Wings for Life

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury Cervical

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Functional electrical stimulation therapy

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Functional electrical stimulation therapy.

Intervention Description

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

Primary Outcome Measure Information:

Title

Muscle strength recovery profile

Description

Change over time in manual muscle testing conducted on each treated muscle.

Time Frame

Muscle strength assessed at each of 30 therapy sessions (3-5 sessions per week).

Secondary Outcome Measure Information:

Title

Surface electromyography signal features

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sharmini Atputharaj

Phone

1-416-597-3422

Ext

6119

Sharmini.Atputharaj@uhn.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José Zariffa, PhD

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sukhvinder Kalsi-Ryan, PhD

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto Rehabilitation Institute - University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4G 3V9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sharmini Atputharaj

Phone

1-416-597-3422

Ext

6119

Sharmini.Atputharaj@uhn.ca

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Prediction of Muscle Responsiveness to FES Therapy

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