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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electrical stimulation of leg muscles can improve balance and walking in people who have had a stroke. The goal is to determine if this stimulation enhances stability during sudden slips or trips and improves walking under various conditions. Participants will test this in both lab and outdoor settings. It suits stroke survivors with one-sided weakness who can walk at least 300 feet, even with a walking aid. As an unphased trial, this study offers stroke survivors the chance to contribute to innovative research that could enhance rehabilitation techniques.

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 prior data suggests that this electrical muscle stimulation is safe for stroke patients?

Research has shown that functional electrical stimulation (FES) and neuromuscular electrical stimulation (NMES) are generally well-tolerated by people recovering from a stroke. Studies have found that these treatments can improve muscle function and balance in stroke survivors. In one study, mild falls were the most common side effect, occurring in a few patients but not directly caused by the treatment. This suggests that FES and NMES are safe options for enhancing balance and walking style in individuals who have experienced a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using electrical muscle stimulation, specifically FES and NMES, to help stroke survivors with balance and fall risk because these techniques offer a novel approach to rehabilitation. Unlike traditional physical therapy, which typically involves exercises to strengthen muscles and improve coordination, FES and NMES directly stimulate the muscles of the affected side to prompt movement and strengthen them. This direct stimulation could lead to faster and more targeted recovery of muscle function, potentially improving balance and reducing the risk of falls more efficiently. By providing electrical stimulation that can be adjusted for comfort and tolerance, these treatments might offer a more personalized and effective rehabilitation method for stroke patients.

What evidence suggests that this electrical muscle stimulation is effective for improving balance and reducing fall risk in stroke patients?

Research has shown that functional electrical stimulation (FES) can significantly help stroke patients improve balance and reduce the risk of falling. One study found that FES reduced the number of falls from 10 to 2 over eight weeks and helped patients lift their feet higher, decreasing the likelihood of tripping. Neuromuscular electrical stimulation (NMES) has also improved balance, ankle stability, and muscle function, aiding stroke patients in walking more evenly. In this trial, participants will receive FES to assess its effects on reactive balance and laboratory falls. These treatments send small electrical pulses to activate muscles, strengthening them and improving coordination. Overall, FES and NMES offer promising benefits for people recovering from strokes. ^{2 3 4 6 7}

Who Is on the Research Team?

Tanvi Bhatt, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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) 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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8984173/

Therapeutic Effects of Functional Electrical Stimulation on ... This review covers the principles, underlying mechanisms, and therapeutic effects of FES on physical performance and skeletal muscle function in post-stroke ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1934148216310942

Effects of Functional Electrical Stimulation on Reducing ... A reduction in the number of falls was observed from baseline (n = 10) to the 8-week assessment (n = 2), P = .02. Foot clearance increased (+5.26 mm, P = .04) ...

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-024-01462-2

Implications of neuromuscular electrical stimulation on gait ... Currently, numerous studies have pointed out the effectiveness of NMES in improving balance, ankle stability, gait symmetry and muscle ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1272992/full

A systematic review on functional electrical stimulation ... 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8904887/

Neuromuscular Electrical Stimulation Improves Activities of ... The results of the present meta-analysis are indicative of potential beneficial effects of NMES toward improving ADL post stroke.

6. aetna.com aetna.com/cpb/medical/data/600_699/0677.html

Functional Electrical Stimulation and Neuromuscular ... This Clinical Policy Bulletin addresses functional electrical stimulation and neuromuscular electrical stimulation.

7. mdpi.com mdpi.com/2077-0383/12/7/2638

Effect of Functional Electrical Stimulation in Convalescent ... The most frequent AE was falling (five events in three patients in the FES group), with mild severity in all cases, and no events were related ...