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

18 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment FES Implementation for cerebral palsy?

Research shows that functional electrical stimulation (FES) can improve walking ability and muscle size in children with cerebral palsy, making it a promising alternative to traditional braces that may limit movement. ^{1 2 3 4 5}

Is functional electrical stimulation (FES) safe for use in children with cerebral palsy?

Research on functional electrical stimulation (FES) in children with cerebral palsy suggests it is generally safe. A pilot study on BCI-FES (brain computer interface-activated FES) specifically assessed safety and feasibility, indicating it can be safely used in children with hemiparetic cerebral palsy. ^{1 5 6 7 8}

How does functional electrical stimulation differ from other treatments for cerebral palsy?

Functional electrical stimulation (FES) is unique because it uses electrical impulses to activate specific muscles during movement, improving walking and muscle function without the constraints of traditional braces. Unlike orthotics, which can limit movement, FES allows for more natural muscle use and may enhance muscle growth and function over time. ^{1 2 4 7 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of lower limb functional electrical stimulation on gait of children with cerebral palsy. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Muscle plasticity and ankle control after repetitive use of a functional electrical stimulation device for foot drop in cerebral palsy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation to the dorsiflexors and quadriceps in children with cerebral palsy. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Acceptability and potential effectiveness of a foot drop stimulator in children and adolescents with cerebral palsy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of short-term daily community walk aide use on children with unilateral spastic cerebral palsy. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Functional Benefit and Orthotic Effect of Dorsiflexion-FES in Children with Hemiplegic Cerebral Palsy. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Therapeutic effects of functional electrical stimulation of the upper limb of eight children with cerebral palsy. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

BCI-activated electrical stimulation in children with perinatal stroke and hemiparesis: A pilot study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Is functional electrical stimulation an alternative for orthotics in patients with cerebral palsy? A literature review. [2018]