Electrical Muscle Stimulation for Stroke Balance and Fall Risk

(NMES Trial)

Overseen By Lakshmi Kannan, MS,PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Botox

Disqualifiers: Neurological, Cardiopulmonary, Musculoskeletal, others

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

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to describe the effect of neuromuscular electrical stimulation (NMES) in the form of functional electrical stimulation (FES) applied to different lower limb muscles on reactive balance and gait performance in stroke participants. Methods: Twenty individuals with chronic stroke will be asked to perform an experimental protocol that includes a postural disturbance in the form of a slip- or trip-like perturbation and a standardized walking test in both laboratory and outdoor environments with and without FES applied to different lower limb muscles of the paretic leg. FES will be applied using an advanced software that is able to synchronize muscle activation with the time of perturbation onset and according to the phases of gait. This project design aims to examine whether a specific pattern of lower limb muscle stimulation could improve the kinematic and behavioral responses during reactive balance following slip- and trip-like perturbations. Additionally, the project aims to see if the kinematic and spatio-temporal gait parameters can be modified during a standardized walking test under different sensory and environmental conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment FES for improving balance and reducing fall risk in stroke patients?

Research shows that functional electrical stimulation (FES) can improve balance and confidence in stroke patients, enhance standing balance when combined with standing frame training, and increase muscle strength and physical performance, which may help prevent falls. ^{1 2 3 4 5}

Is electrical muscle stimulation safe for humans?

Research shows that neuromuscular electrical stimulation (NMES) is generally safe for humans, including those with implantable cardioverter defibrillators (ICDs), as long as individual risks are assessed beforehand. In a study with patients using ICDs, no adverse events were reported during long-term NMES treatment. ^{6 7 8 9 10}

How does the treatment FES/NMES differ from other treatments for improving balance and reducing fall risk in stroke patients?

FES/NMES (Functional Electrical Stimulation/Neuromuscular Electrical Stimulation) is unique because it uses electrical impulses to stimulate muscles, helping to restore movement and improve balance in stroke patients. Unlike conventional therapy, FES can specifically target and activate paralyzed muscles, enhancing muscle function and balance more effectively. ^{1 2 3 4 11}

Research Team

Tanvi Bhatt, PhD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for adults aged 18-90 who've had a stroke at least 6 months ago, can walk independently (with or without help) for at least 300 ft, and have no major health issues like heart disease or uncontrolled high blood pressure. They should be able to understand English and follow the study's instructions.

Inclusion Criteria

Can understand and communicate in English

I can walk on my own for at least 300 feet, with or without help like a cane.

I am mentally able to follow the treatment plan.

Exclusion Criteria

You have a pacemaker.

My skin reacts badly to FES therapy.

I have a heart, lung, muscle, or systemic health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 session

1 visit (in-person)

Experimental Protocol

Participants undergo testing and training with NMES applied to lower limb muscles during slip- or trip-like perturbations and standardized walking tests.

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the experimental protocol

4 weeks

Treatment Details

Interventions

• FES
• NMES

Trial Overview The study tests if neuromuscular electrical stimulation (NMES), specifically functional electrical stimulation (FES) on lower limb muscles, can improve balance and walking after a stroke. Participants will try walking with FES in different settings while their movement is monitored.

Participant Groups

Group I: Effect of functional electrical stimulation on reactive balance and laboratory falls Experimental Treatment 1 Intervention

All individuals will be assigned to the experimental group and will undergo the testing and training procedure across two separate sessions. During the first session, the participants will go through the complete initial screening process. If eligible for the study, the participants will perform the experimental training protocols during the second session. Experimental Protocol The quadriceps, hamstrings, tibialis anterior, gastrocnemius, and the trunk muscle group on the stroke-affected side (weaker side) will be stimulated according to the participant's comfort and tolerance. The range of the intensity allowed by the device is 0-50milliamperes (mA). The frequency of the electrical stimulation device ranges from 1-60Hz.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Findings from Research

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]

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]

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 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]

Functional electrical stimulation (FES) has been shown to effectively restore strength in key muscle groups, such as dorsiflexors and hip abductors, which are crucial for improving gait and balance in older adults who have suffered a stroke.

FES may also help increase muscle mass and strength, potentially preventing muscle atrophy, but more research is needed to fully understand its benefits in post-stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Functional Electrical Stimulation on Physical Performance and Muscle Strength in Post-stroke Older Adults: A Review. Shin, HE., Kim, M., Lee, D., et al.[2022]

A resistance training form of neuromuscular electrical stimulation (NMES) was successfully applied to individuals with motor complete spinal cord injury, leading to significant increases in muscle mass averaging 30% to 40% over 3 to 6 months of training.

Participants experienced no adverse events and showed consistent progress in their ability to perform more repetitions and lift heavier weights, indicating that NMES can effectively stimulate muscle growth and function even years after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation-Induced Resistance Training After SCI: A Review of the Dudley Protocol. Bickel, CS., Yarar-Fisher, C., Mahoney, ET., et al.[2018]

In a study involving 10 adults, neuromuscular electrical stimulation (NMES) with a 200-microsecond pulse duration allowed participants to tolerate significantly greater muscle torques compared to a 50-microsecond pulse duration, indicating enhanced efficacy for muscle strengthening.

The findings suggest that medium pulse durations may be more effective for maximizing muscle torque responses, despite the common belief that shorter pulses are preferable due to lower pain thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. Scott, WB., Causey, JB., Marshall, TL.[2014]

A pilot safety study involving six patients with implantable cardioverter defibrillators (ICDs) showed that long-term neuromuscular electrical stimulation (NMES) of thigh muscles is safe, with no adverse events reported during the treatment.

All patients received a total of over 14 million electrical pulses without any abnormalities in ICD function, suggesting that NMES can be a viable option for improving muscle strength and endurance in patients with chronic heart failure who have ICDs, provided individual risks are assessed beforehand.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. Crevenna, R., Wolzt, M., Fialka-Moser, V., et al.[2022]

Neuromuscular electrical stimulation (NMES) has been shown to effectively increase quadriceps muscle strength in healthy young adults, although it is less effective than voluntary resistance training, based on a review of 32 randomized controlled trials involving 796 participants.

The evidence for NMES improving quadriceps muscle strength and mass in older adults is limited and requires further high-quality research, as only 5 trials with 123 participants were available for analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Neuromuscular Electrical Stimulation on Quadriceps Muscle Strength and Mass in Healthy Young and Older Adults: A Scoping Review. Rahmati, M., Gondin, J., Malakoutinia, F.[2021]

The newly developed NMES-dynamometer system demonstrated high reliability for assessing knee extensor muscle function, with intra-rater correlation coefficients of 0.91 for maximal voluntary force and 0.94 for supramaximal twitch force, indicating consistent results across different testing sessions.

Inter-rater reliability was also strong, with coefficients of 0.89 and 0.86 for the same measures, suggesting that different raters can use this system effectively to evaluate muscle function with minimal variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and reliability of a new system for bedside evaluation of non-volitional knee extension force. Vaz, MA., Fröhlich, M., Júnior, DPDS., et al.[2022]

In a study of 49 stroke patients, balance training combined with electromyogram-triggered functional electrical stimulation (EMG-triggered FES) significantly improved both static and dynamic balance compared to conventional training alone.

The experimental group also showed notable enhancements in ankle muscle activation on the affected side, indicating that EMG-triggered FES is an effective intervention for improving balance and muscle function in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balance Training with Electromyogram-Triggered Functional Electrical Stimulation in the Rehabilitation of Stroke Patients. Lee, K.[2020]

References

1. 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]

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

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

3. 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]

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

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

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

Therapeutic Effects of Functional Electrical Stimulation on Physical Performance and Muscle Strength in Post-stroke Older Adults: A Review. [2022]

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

Neuromuscular Electrical Stimulation-Induced Resistance Training After SCI: A Review of the Dudley Protocol. [2018]

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

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. [2014]

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

Long-term transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. [2022]

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

Effects of Neuromuscular Electrical Stimulation on Quadriceps Muscle Strength and Mass in Healthy Young and Older Adults: A Scoping Review. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Development and reliability of a new system for bedside evaluation of non-volitional knee extension force. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Balance Training with Electromyogram-Triggered Functional Electrical Stimulation in the Rehabilitation of Stroke Patients. [2020]