Electrical Stimulation & Visual Feedback for Stroke

Overseen By Kristin E Musselman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Botulinum toxin

Disqualifiers: Lower extremity fracture, Peripheral nerve damage, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Falls are an "emerging public health crisis" that cost the Canadian health care system billions of dollars each year. Moreover falls have a significant, detrimental impact on the lives of those who fall. In addition to physical injury and hospital admission, individuals may experience a post-fall syndrome characterized by dependence, depression, and reduced mobility and participation. Individuals living with the effects of neurological disease or injury are at a particularly high risk of falling. For example, 69-78% of individuals with spinal cord injury or disease (SCI/D) and 73% of individuals post-stroke fall at least once per year. Despite this high fall risk, evidence-based initiatives to prevent falls among those with SCI/D or stroke are lacking in neurorehabilitation. Furthermore, little time is dedicated to improving balance during inpatient neurorehabilitation. For example, ambulatory inpatients with SCI/D spend, on average, a mere 2.0±2.0 hours on balance training over the course of their entire inpatient stay. Our team is developing effective solutions to the "high-volume, high-risk and high-cost challenge" of falls. Our long-term objective is to develop an intervention that improves balance in a clinically meaningful and feasible way, facilitating the recovery of safe upright mobility and addressing the current health crisis of falls in individuals living with neurological disease or injury. The intervention will be developed with a focus on neurological populations, as these patient groups have a critical need for balance training; however, the intervention will be transferrable to other populations at risk of falls, such as older able-bodied adults. A probable solution to the gap in balance interventions is functional electrical stimulation (FES), whereby an electrical current is applied to peripheral nerves to facilitate muscle contractions. By applying the appropriate amount of electrical stimulation at the appropriate time during movement execution, the central nervous system can be re-educated, facilitating motor and functional improvements. The investigators developed a closed-loop FES system whose controller mimics the physiological control system. By combining this system with visual feedback balance training (VFBT), the investigators developed a prototype system of FES and VFBT (FES+VFBT). This intervention involves standing on a force plate with one's centre of pressure (COP) presented on a monitor. As the user moves his/her COP in response to a game, FES is delivered to the plantarflexor and dorsiflexor muscles through the device, MyndSearch.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have had an injection of botulinum toxin to leg muscles in the past two weeks or plan to have one during the treatment period, you may not be eligible to participate.

What data supports the effectiveness of the treatment FES+VFBT for stroke patients?

Research shows that functional electrical stimulation (FES) can improve balance and confidence in stroke patients, and visual feedback training can enhance muscle activation and balance. Combining these therapies, as in FES+VFBT, may help improve balance and walking ability in stroke patients. ^{1 2 3 4 5}

Is functional electrical stimulation (FES) generally safe for humans?

Functional electrical stimulation (FES) has been used safely in various studies for stroke rehabilitation, helping with muscle function and balance without significant safety concerns reported. ^{2 6 7 8 9}

How is the FES+VFBT treatment for stroke different from other treatments?

The FES+VFBT treatment is unique because it combines functional electrical stimulation (FES) with visual feedback to improve balance and muscle function in stroke patients. This approach uses real-time feedback from sensors to adjust muscle stimulation, which is not commonly found in other stroke rehabilitation therapies. ^{1 2 7 8 10}

Research Team

Kristin E Musselman, PhD

Principal Investigator

KITE-Toronto Rehabilitation Institute, UHN

Eligibility Criteria

This trial is for adults over 18 who can stand on their own for a minute, understand English, and have moderate trunk control. It's specifically for those with non-progressive spinal cord injury/disease or stroke that happened over a year ago and are not improving naturally anymore. People with other conditions affecting walking/balance or specific contraindications like recent fractures, botulinum toxin injections, nerve damage in legs, certain medical devices implanted, cancer treatments within six months, uncontrolled epilepsy or skin issues at electrode sites cannot join.

Inclusion Criteria

I have a spinal cord injury or stroke that hasn't worsened and can still move some muscles.

It's been over a year since my spinal cord injury/stroke, and my recovery has plateaued.

Able to understand spoken English

Exclusion Criteria

I do not have a history of epilepsy or seizures.

I have had a fracture in my leg due to weak bones.

I have not had a botulinum toxin injection in my legs in the last two weeks and do not plan to during treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FES+VFBT intervention, involving standing on a force plate with COP presented on a monitor and FES delivered to muscles

3 weeks

Multiple sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up assessments at 6 and 12 weeks

Treatment Details

Interventions

• FES+VFBT

Trial Overview The study tests an intervention called FES+VFBT designed to improve balance and prevent falls in people affected by neurological diseases or injuries like spinal cord injury/disease (SCI/D) or stroke. Participants will use a system combining functional electrical stimulation (FES) with visual feedback balance training (VFBT), standing on a force plate while responding to visual cues that help train muscle response through electrical stimulation.

Participant Groups

Group I: FES+VFBT Experimental Treatment 1 Intervention

Functional electrical stimulation combined with visual feedback balance training

FES+VFBT is already approved in Canada for the following indications:

Approved in Canada as FES+VFBT for:

• Balance training for individuals with neurological disease or injury
• Prevention of falls in individuals with spinal cord injury or disease (SCI/D) and stroke

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

Combining functional electrical stimulation (FES) with standing frame training significantly improved standing balance in stroke patients compared to separate treatments, as shown by better scores on the Berg Balance Scale and stability indices after 3 weeks of therapy.

The study involved 60 patients with hemiparesis and postural instability, demonstrating that this combined approach is not only effective but also practical for clinical use, making it a promising option for rehabilitation in subacute stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Therapy With Functional Electrical Stimulation and Standing Frame in Stroke Patients. Lee, JB., Kim, SB., Lee, KW., et al.[2023]

In a study involving 15 adults with chronic stroke, functional electrical stimulation (FES) applied during gait training led to small but significant improvements in balance function and toe clearance, although gait speed did not change.

Despite physical improvements, over half of the participants reported decreased balance confidence while using the FES device, indicating that while FES can enhance balance, it may also create challenges in confidence for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of functional electrical stimulation on balance function and balance confidence in community-dwelling individuals with stroke. Robertson, JA., Eng, JJ., Hung, C.[2021]

In a study involving 21 hemiplegic stroke patients, those who received visual feedback training with visual targets showed significantly greater improvements in muscle activation and balance compared to those who only received visual feedback training without targets.

The experimental group demonstrated enhanced gluteus medius muscle activation and better weight-bearing ability on the affected side, suggesting that incorporating visual targets can be an effective strategy in rehabilitation for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of visual feedback training and visual targets on muscle activation, balancing, and walking ability in adults after hemiplegic stroke: a preliminary, randomized, controlled study. Pak, NW., Lee, JH.[2021]

In a study of 38 stroke patients, functional electrical stimulation (FES) combined with physical therapy showed a significant improvement in functional deficits after 4 weeks (p < 0.01).

While there were no significant differences in overall outcomes between the FES and control groups at 4 and 8 weeks, FES-treated patients demonstrated a better rate of recovery in ambulation scores (p < 0.05), suggesting potential additional benefits in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation to the affected lower limb and recovery after cerebral infarction. Macdonell, RA., Triggs, WJ., Leikauskas, J., et al.[2015]

Functional electrical stimulation (FES) combined with conventional therapy significantly improves balance in post-stroke patients, as shown by better scores on the Berg Balance Scale and Timed Up and Go Scale in a review of 9 studies involving 255 participants.

No adverse effects were reported in the studies, indicating that FES is a safe intervention for enhancing balance in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Electrical Stimulation of Lower Extremity Muscles on Balance in Stroke Patients: A Systematic Review of Literatures. Mahmoudi, Z., Mohammadi, R., Sadeghi, T., et al.[2021]

Functional electrical stimulation (FES) can enhance sensory-motor processing, as indicated by changes in theta band coherence in the brain during tasks involving electrical stimulation of the hand.

The study found that different conditions of electrostimulation affected brain coherence in specific areas, suggesting that FES may improve memory functions related to motor tasks, with implications for rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of functional electro-stimulation in the theta-band coherence: a quantitative electroencephalograph study. Santos, J., Velasques, B., Paes, F., et al.[2011]

Functional electrical stimulation (FES) can help restore movement in stroke patients by using a portable neuroelectric stimulator that the patient can control, particularly effective for conditions like dropfoot.

While lower extremity FES systems have been successfully developed to aid walking, creating effective upper extremity systems for hand and finger movements remains a challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent applications of functional electrical stimulation to stroke patients in Ljubljana. Vodovnik, L., Kralj, A., Stanic, U., et al.[2005]

The developed feedback-controlled functional electrical stimulation (FES) system provides real-time muscle stimulation for hemiplegic patients, helping to prevent drop-foot and quadriceps weakness during gait training.

The FES system uses tilt sensors and footswitches to automatically adjust stimulation parameters, ensuring optimal support for patients as they walk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the tilt sensors feedback controlled FES for hemiplegia. Chen, YL., Shih, YY., Chen, WL., et al.[2020]

The hybrid functional electrical stimulation (FES) orthosis combines a rigid brace with a multi-channel FES system to provide stability for patients with spinal cord injuries, allowing them to maintain standing postures without muscle fatigue during prolonged use.

Preliminary tests on two spinal cord injured subjects indicate that the FES controller effectively responds to destabilizing shifts, stimulating the necessary muscles to maintain balance and support leg movement during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid FES orthosis incorporating closed loop control and sensory feedback. Andrews, BJ., Baxendale, RH., Barnett, R., et al.[2019]

Functional electrical stimulation (FES) combined with voluntary movement (FESVOL) enhances cerebellar activity and may improve rehabilitation outcomes for post-stroke hemiplegia, suggesting a synergistic effect between electrical stimulation and voluntary effort.

The study indicates that FESVOL leads to reduced activity in secondary somatosensory areas, which may reflect a more accurate internal model of movement, potentially improving the effectiveness of rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction of electrical stimulation and voluntary hand movement in SII and the cerebellum during simulated therapeutic functional electrical stimulation in healthy adults. Iftime-Nielsen, SD., Christensen, MS., Vingborg, RJ., et al.[2021]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Combined Therapy With Functional Electrical Stimulation and Standing Frame in Stroke Patients. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

The effect of functional electrical stimulation on balance function and balance confidence in community-dwelling individuals with stroke. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effects of visual feedback training and visual targets on muscle activation, balancing, and walking ability in adults after hemiplegic stroke: a preliminary, randomized, controlled study. [2021]

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

Functional electrical stimulation to the affected lower limb and recovery after cerebral infarction. [2015]

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

The Effects of Electrical Stimulation of Lower Extremity Muscles on Balance in Stroke Patients: A Systematic Review of Literatures. [2021]

6. Spain pubmed.ncbi.nlm.nih.gov

Effects of functional electro-stimulation in the theta-band coherence: a quantitative electroencephalograph study. [2011]

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

Recent applications of functional electrical stimulation to stroke patients in Ljubljana. [2005]

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

Clinical evaluation of the tilt sensors feedback controlled FES for hemiplegia. [2020]

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

Hybrid FES orthosis incorporating closed loop control and sensory feedback. [2019]

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

Interaction of electrical stimulation and voluntary hand movement in SII and the cerebellum during simulated therapeutic functional electrical stimulation in healthy adults. [2021]