Cerebral Palsy (CP)NCT06689007
FES Implementation Pediatrics
A study testing Implementation Intervention in people with Cerebral Palsy (CP), run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Implementation Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2024to 18 Jul 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Implementation Intervention
- Keywords
- functional electrical stimulation, implementation intervention, physical therapist, occupational therapist
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Implementation Intervention | Experimental | Not described Receives: Other: Implementation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
FES knowledge quiz
Measured: From pre-intervention to immediately post-intervention and six months post-intervention
FES Confidence Questionnaire
Measured: From pre-intervention to immediately post-intervention and six months post-intervention
FES Use Survey
Measured: From pre-intervention to immediately post-intervention and six months post-intervention
Technology Assistance Model 2 Questionnaire
Measured: From pre-intervention to immediately post-intervention and six months post-intervention
Semi-structured Interview
Guided by the RE-AIM Framework
Measured: Six months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Oct 2024
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Musselman, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689007
- Sponsor's protocol ID
- 46640
- Status last verified
- Jul 2025
- First submitted
- 12 Nov 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating Change in Pediatric Rehabilitation: An Implementation Intervention to Increase Use of Functional Electrical Stimulation
- ClinicalTrials.gov ID
- NCT06689007
- Acronym / sponsor ID
- 46640
- Conditions
- Cerebral Palsy (CP)
- Keywords
- functional electrical stimulation, implementation intervention, physical therapist, occupational therapist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implementation Intervention | Experimental | Other: Implementation Intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation InterventionThe 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. | Other | Implementation Intervention |
Primary outcome
FES knowledge quiz
Time frame: 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
FES Use Survey
Time frame: 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
Semi-structured Interview
Time frame: Six months post-intervention
Guided by the RE-AIM Framework
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Intervention in people with Cerebral Palsy (CP), 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 6 inclusion and 0 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 23 Jul 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?
FES knowledge quiz (time frame: From pre-intervention to immediately post-intervention and six months post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2025.