Functional Electrical Stimulation for Stroke
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called Functional Electrical Stimulation (FES), which uses electrical signals to improve muscle function for walking. It focuses on individuals with neurological conditions such as stroke, traumatic brain injury, or multiple sclerosis who have difficulty lifting their feet while walking. Researchers aim to assess how FES affects walking speed and balance and whether its effects vary based on the neurological condition. Individuals who have experienced a stroke or brain injury and have difficulty with foot movement might be suitable candidates. The goal is to enhance walking and develop better rehabilitation plans for these conditions. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance rehabilitation strategies for neurological conditions.
What prior data suggests that the L300 device is safe for improving walking in people with neurological conditions?
Research has shown that functional electrical stimulation (FES) is generally safe for people with neurological conditions. Studies have found that stroke survivors and individuals with conditions like multiple sclerosis can use FES without major safety concerns. For instance, one study found that people with multiple sclerosis could safely use FES cycling, even at challenging settings. Another review noted that FES helps improve movement in those recovering from a stroke, with no significant side effects reported.
Overall, FES uses mild, painless electrical signals to help muscles move and is considered well-tolerated. Current evidence supports its safety in improving physical performance and walking ability in various neurological conditions.12345Why are researchers excited about this trial?
Researchers are excited about using Functional Electrical Stimulation (FES) for conditions like stroke, traumatic brain injury, and multiple sclerosis because it offers a unique approach to improving mobility. Unlike traditional therapies that often rely on physical exercises and therapies, FES directly stimulates the nerves and muscles involved in walking, which can lead to more immediate enhancements in gait and mobility. This technique uses the L300 Go device to provide personalized electrical pulses, helping patients achieve better ankle movement during walking. By potentially improving gait performance in just a few weeks, FES could offer a promising alternative or complement to current rehabilitation methods.
What evidence suggests that the L300 device is effective for improving walking in people with neurological conditions?
Research has shown that functional electrical stimulation (FES) can assist individuals with foot drop, particularly after a stroke. Studies have found that FES applied to the nerves in the lower leg enhances ankle movement and walking ability. For instance, one study found that FES significantly aided stroke patients by improving motor control, crucial for better walking. This trial will evaluate FES in two settings: one as part of a randomized controlled trial with multiple sessions and another involving a single session to assess feasibility. Medium-frequency FES has been linked to the best results for foot drop after a stroke, making it a promising treatment option. Overall, FES appears to be an effective method for improving walking in people with neurological conditions.16789
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Comprehensive gait evaluation using Baliston Health and OneStep systems
Treatment
Participants receive FES via the L300 Go device during supervised sessions over 4 weeks
Post-Intervention Assessment
Repeat gait evaluation immediately following the intervention period
Follow-up
A 12-week post-intervention assessment to evaluate retention of gait improvements
What Are the Treatments Tested in This Trial?
Interventions
- Functional Electrical Stimulation
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
A prospective, randomized, controlled trial will be conducted with N = 90 participants, stratified into three diagnostic groups (30 per group): * Group 1: Stroke * Group 2: Traumatic Brain Injury * Group 3: Multiple Sclerosis (or other specified neurological condition) Procedures: * Baseline Assessment: Comprehensive gait evaluation using Baliston Health and OneStep systems. * Intervention: Participants will receive FES via the L300 Go device during supervised sessions over 4 weeks. Stimulation parameters will be individualized and adjusted to optimize gait performance. Gait will be assessed each week for the 4 weeks. * Post-Intervention Assessment: Repeat gait evaluation immediately following the intervention period. * Follow-Up: A 12-week post-intervention assessment will be conducted to evaluate retention of gait improvements.
Participants will undergo a single supervised session involving: 1. Baseline gait assessment using the Baliston Health Gait System and the OneStep Gait Measurement Application. 2. FES intervention with the L300 system (e.g., Bioness L300 Go), titrated to individual needs to facilitate ankle dorsiflexion. 3. Immediate post-intervention gait assessment to evaluate changes in gait parameters with the L300. This component will establish feasibility and inform protocol refinements for the randomized controlled trial.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Casa Colina Hospital and Centers for Healthcare
Lead Sponsor
Citations
A systematic review on functional electrical stimulation based ...
The review analyzed 25 studies and found that the use of FES-based rehabilitation systems resulted in favorable outcomes for the stroke recovery of upper limb ...
Functional electrical stimulation enhances motor control in ...
The study found that integrating electrical stimulation with early rehabilitation markedly enhanced stroke patients' recovery.
Efficacy of functional electrical stimulation at different ...
In this retrospective comparative study, medium-frequency (31–40 Hz) FES was associated with optimal efficacy and safety outcomes for post-stroke FD, showing ...
Efficacy of Functional Electrical Stimulation for Limb ...
Recent studies indicate that functional electrical stimulation (FES) applied to lower limb nerves is effective for foot drop due to stroke.
Effect of electrical stimulation in the treatment on patients ...
In summary, this existing evidence shows that ES can improve the ROM of ankle dorsiflexion and lower limb motor function in patients with FD after stroke. In ...
Comparison of Gait Metrics in Patients With Stroke ...
FES has demonstrated benefits for improving motor function and gait in populations such as stroke survivors, individuals with spinal cord injury ...
Safety and Feasibility of Various Functional Electrical ...
People with multiple sclerosis who are nonambulatory can safely perform functional electrical stimulation (FES) cycling using parameters requiring more effort.
Therapeutic Effects of Functional Electrical Stimulation ... - PMC
This review covers the principles, underlying mechanisms, and therapeutic effects of FES on physical performance and skeletal muscle function in post-stroke ...
Contralaterally Controlled Functional Electrical Stimulation ...
This study compared the effects of contralaterally controlled functional electrical stimulation (CCFES) to cyclic neuromuscular electrical ...
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