Functional Electrical Stimulation for Cerebral Palsy

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Non-therapists, Non-Canadian, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve physical therapy for children with cerebral palsy (CP) by using Functional Electrical Stimulation (FES), a technique that enhances movement and sensory responses. FES has proven successful in adults with neurological issues like strokes, and the trial now seeks to train Canadian therapists to use it for children with CP. The goal is to enhance therapists' confidence and skills through an online course and toolkit. Therapists in Canada who frequently treat CP but have limited experience with FES are ideal candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative therapy techniques for children with CP.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this FES implementation is safe for children with cerebral palsy?

Research has shown that functional electrical stimulation (FES) is a safe treatment. Studies have found it to be well-tolerated by both adults and children with cerebral palsy (CP). FES helps improve muscle function and movement skills. For adults with CP, FES is safe and cost-effective, particularly for those who have difficulty walking.

In children with CP, FES aids in muscle activation and learning new movements, addressing neurological challenges. Although FES is not yet widely used in Canada for children, research suggests it is a safe option for improving motor skills in children with CP. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Functional Electrical Stimulation (FES) for cerebral palsy is unique because it offers a way to directly stimulate muscles and nerves, potentially improving movement and coordination. Unlike traditional therapies like physical therapy, which focus on exercises and physical manipulation to enhance function, FES uses electrical currents to activate specific muscle groups. This technique could lead to more targeted improvements in motor skills and might offer benefits even in cases where conventional therapies have plateaued. Researchers are excited about FES because it provides a new avenue to enhance motor function and quality of life for individuals with cerebral palsy.

What evidence suggests that FES is effective for cerebral palsy?

Research has shown that functional electrical stimulation (FES), which participants in this trial will receive, can help children with cerebral palsy (CP) improve movement and strength. Studies have found that FES is more effective than not using it and is about as effective as activity training alone. For children with CP, FES can increase range of motion, muscle size, and strength. It might also enhance balance, particularly in children with specific types of CP, such as hemiplegic CP. Overall, FES is considered a safe and effective method to help children with CP enhance their physical abilities. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for pediatric physical and occupational therapists who are looking to improve their knowledge, confidence, and use of Functional Electrical Stimulation (FES) in treating children with Cerebral Palsy. There's no specific mention of inclusion or exclusion criteria for participants.

Inclusion Criteria

I can attend a six-week online course from Oct 18 to Nov 28, 2024.

Licensed to practice physical or occupational therapy in Canada

Reports that CP comprises ≥20% of their caseload over the past year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation Intervention

Participants undergo an implementation intervention consisting of an online course and toolkit for physical and occupational therapists

6 months

Follow-up

Participants are monitored for changes in knowledge, confidence, and use of FES

6 months

What Are the Treatments Tested in This Trial?

Interventions

• FES Implementation

Trial Overview The study is testing an online course and toolkit designed as an implementation intervention to help therapists incorporate FES into their practice. The goal is to see if this training can overcome barriers like lack of knowledge and access to equipment.

How Is the Trial Designed?

Group I: Implementation Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

The pilot clinical trial involving 13 children with hemiparetic cerebral palsy demonstrated that Brain Computer Interface-activated Functional Electrical Stimulation (BCI-FES) is safe and well-tolerated, with no serious adverse events reported.

Participants showed good competency with the BCI system, achieving mean classification accuracies of approximately 79% during training and 73% during rehabilitation, indicating the potential for this technology to enhance upper extremity function in children with limited rehabilitation options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BCI-activated electrical stimulation in children with perinatal stroke and hemiparesis: A pilot study. Jadavji, Z., Kirton, A., Metzler, MJ., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24819681/

Effect of functional electrical stimulation on activity in ... The available evidence suggests that FES is more effective than no FES but that it has a similar effect as activity training alone in cerebral palsy.

2. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01538-z

Functional electrical stimulation for walking in adults with ... FES is a safe, cost-effective treatment option and should be considered, for adults with CP who have walking difficulties.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02462018

Effects of Functional Electrical Stimulation on Gait in ... These studies showed improvement in laboratory and functional gait parameters. There are relatively few studies on children with hemiplegic or diplegic CP with ...

4. cerebralpalsyguidance.com cerebralpalsyguidance.com/cerebral-palsy/treatment/functional-electrical-stimulation/

Functional Electrical Stimulation In children with cerebral palsy, functional electrical stimulation has been found to improve range of motion, muscle mass, muscle strength, ...

5. bfpt.springeropen.com bfpt.springeropen.com/articles/10.1186/s43161-021-00040-0

Effect of functional electrical stimulation on postural control ... Functional electrical stimulation may be a useful tool to enhance the postural stability of children with hemiplegic cerebral palsy.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40022119

Functional electrical stimulation for walking in adults with ... FES is a safe, cost-effective treatment option and should be considered, for adults with CP who have walking difficulties.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1751722219301763

Functional electrical stimulation (FES) for children and ... Children with CP benefit from FES due to their neurological impairment affecting muscle activation and learning of movement.