NCT06689007

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

November 12, 2024

Last Update Submit

July 22, 2025

Conditions

Keywords

functional electrical stimulationimplementation interventionphysical therapistoccupational therapist

Outcome Measures

Primary Outcomes (5)

  • FES knowledge quiz

    From pre-intervention to immediately post-intervention and six months post-intervention

  • FES Confidence Questionnaire

    From pre-intervention to immediately post-intervention and six months post-intervention

  • FES Use Survey

    From pre-intervention to immediately post-intervention and six months post-intervention

  • Technology Assistance Model 2 Questionnaire

    From pre-intervention to immediately post-intervention and six months post-intervention

  • Semi-structured Interview

    Guided by the RE-AIM Framework

    Six months post-intervention

Study Arms (1)

Implementation Intervention

EXPERIMENTAL
Other: Implementation Intervention

Interventions

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.

Implementation Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5G 1V7, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 14, 2024

Study Start

October 1, 2024

Primary Completion

July 18, 2025

Study Completion

July 18, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations