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Spinal Cord Injury CervicalNCT05462925

Prediction of Muscle Responsiveness to FES Therapy

A study testing Functional electrical stimulation therapy. in people with Spinal Cord Injury Cervical, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injury Cervical
What is being tested?
Functional electrical stimulation therapy.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
20 Jul 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Toronto Rehabilitation Institute - University Health Network

    Toronto, Ontario, M4G 3V9

Other trials in Canada

About this study

Official title: 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.

Being tested
Functional electrical stimulation therapy.
Keywords
Spinal cord injury, Functional electrical stimulation, Upper limb, Electromyography, Prediction.
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional electrical stimulation therapy.Device

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

Study groups in NCT05462925
Study groupRoleWhat they receive
Functional electrical stimulation therapyExperimentalParticipants 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.
Receives: Device: Functional electrical stimulation therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle strength recovery profile

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

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

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2022
  2. Study start20 Jul 2022
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
This prognostic study examines how baseline measurements predict therapy response in a single group of participants.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05462925
Sponsor's protocol ID
19-5395
Status last verified
Jan 2025
First submitted
4 Jul 2022
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data may be shared following study completion upon reasonable request to the investigators and completion of a data sharing agreement.

Publications

  • 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. 2026 Jun;29(4):647-659. doi: 10.1016/j.neurom.2025.08.416. Epub 2025 Oct 16.

    PubMed 41099684

Questions about this trial

What is this clinical trial studying?

A study testing Functional electrical stimulation therapy. in people with Spinal Cord Injury Cervical, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle strength recovery profile (time frame: Muscle strength assessed at each of 30 therapy sessions (3-5 sessions per week).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05462925, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.

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