FES Implementation Pediatrics

July 22, 2025 updated by: Kristin Musselman, University Health Network, Toronto

Stimulating Change in Pediatric Rehabilitation: An Implementation Intervention to Increase Use of Functional Electrical Stimulation

Physical rehabilitation interventions that promote activity-dependent neuroplasticity are desired for children with CP as this will result in improved motor skill and function. In adult neurological populations, such as stroke and spinal cord injury, FES is a recommended, evidence-based intervention that addresses motor and sensory impairments and promotes neuroplasticity. The evidence base supporting the safety, feasibility and efficacy of FES for youth with CP is rapidly growing, yet FES is not commonly used in Canadian pediatric rehabilitation. Through interviews with Canadian pediatric physical and occupational therapists, we identified numerous barriers to FES implementation, including a lack of knowledge and training in FES, difficulty accessing FES equipment, and a perceived lack of time to deliver FES within a treatment session. To address these barriers, we have developed an implementation intervention for FES that consists of an online course and toolkit for physical and occupational therapists. As a next step, we will evaluate the effects of the implementation intervention on pediatric therapists' knowledge, confidence and use of FES.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1V7
        • University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Licensed to practice physical or occupational therapy in Canada.
  2. Report that CP comprises ≥20% of their caseload over the past year.
  3. Has not previously taken a continuing education course in FES.
  4. Reports never (0% of treatment sessions) or rarely (1-20% of treatment sessions) using neuromuscular electrical stimulation (NMES) or FES in their clinical practice.
  5. Report being able to participate in a six-week online FES course from October 18 2024 - November 28 2024.
  6. Able to complete the course and interview in English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implementation Intervention
Other: Implementation Intervention
The intervention employs four established implementation strategies according to the Expert Recommendations for Implementing Change: conduct educational meetings, provide ongoing consultation, provide technical assistance, and change physical structure and equipment. The first component is a six-week online course led by the PI that combines weekly pre-recorded lectures, hands-on activities, group mentoring sessions and a reflective assignment. The second component of the intervention is ensuring access to the equipment needed for FES. The third component of the intervention is access to the FES Toolkit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FES knowledge quiz
Time Frame: From pre-intervention to immediately post-intervention and six months post-intervention
From pre-intervention to immediately post-intervention and six months post-intervention
FES Confidence Questionnaire
Time Frame: From pre-intervention to immediately post-intervention and six months post-intervention
From pre-intervention to immediately post-intervention and six months post-intervention
FES Use Survey
Time Frame: From pre-intervention to immediately post-intervention and six months post-intervention
From pre-intervention to immediately post-intervention and six months post-intervention
Technology Assistance Model 2 Questionnaire
Time Frame: From pre-intervention to immediately post-intervention and six months post-intervention
From pre-intervention to immediately post-intervention and six months post-intervention
Semi-structured Interview
Time Frame: Six months post-intervention
Guided by the RE-AIM Framework
Six months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

July 18, 2025

Study Completion (Actual)

July 18, 2025

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46640

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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