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OpenTrials
Completed

NCT Number: NCT06689007

FES Implementation Pediatrics

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.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Toronto

Toronto, Ontario, M5G 1V7, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Treatment and study plan

Implementation Intervention

Other

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.

Primary outcomes

  1. FES knowledge quiz

    Time frame: From pre-intervention to immediately post-intervention and six months post-intervention

  2. FES Confidence Questionnaire

    Time frame: From pre-intervention to immediately post-intervention and six months post-intervention

  3. FES Use Survey

    Time frame: From pre-intervention to immediately post-intervention and six months post-intervention

  4. Technology Assistance Model 2 Questionnaire

    Time frame: From pre-intervention to immediately post-intervention and six months post-intervention

  5. Semi-structured Interview

    Time frame: Six months post-intervention

    Guided by the RE-AIM Framework

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2024
Registry last updated
Jul 23, 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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