NMES for Reducing Fall Risk

(NMES Trial)

Overseen By Odessa R Addison, PhD DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Hypertension, Home oxygen, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to reduce the risk of falls by strengthening hip muscles through neuromuscular electrical stimulation (NMES). NMES applies electrical impulses to muscles, which can improve strength and balance when combined with regular exercise. The trial will compare two groups: one using NMES with a balance and strengthening program, and another using only the balance and strengthening program. This study is ideal for individuals aged 55 or older who are at risk for falls but do not have uncontrolled high blood pressure or require home oxygen. As an unphased trial, it offers an opportunity to contribute to research that could enhance fall prevention strategies.

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's best to discuss this with the study team to understand how your medications might interact with the trial.

What prior data suggests that this method is safe for improving balance and mobility?

Research shows that neuromuscular electrical stimulation (NMES) is generally safe for people. Studies have found that patients can use NMES safely and comfortably as soon as 24 to 72 hours after a stroke. Trained professionals can also safely apply it to seriously ill patients. This indicates that NMES is well-tolerated by various groups, including more vulnerable individuals.

While more research continues, NMES has shown potential benefits for older adults by improving muscle strength and helping them maintain independence. This suggests that the treatment is not only safe but may also positively impact muscle health and mobility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NMES and MMBI treatments for reducing fall risk because they offer a novel approach to improving balance and muscle strength. Unlike typical physical therapy exercises, NMES involves applying electrical stimulation to the hip abductors, which can enhance muscle activation and strength without requiring voluntary effort. The combination with MMBI, a comprehensive balance intervention, provides a multi-faceted strategy that targets both muscle strengthening and balance improvement simultaneously. This dual approach has the potential to be more effective than traditional methods, which usually focus on balance exercises alone.

What evidence suggests that NMES and MMBI could be effective for reducing fall risk?

Research has shown that neuromuscular electrical stimulation (NMES), a treatment under study in this trial, can strengthen muscles and improve balance, particularly in older adults. NMES sends small electrical signals to the muscles, causing them to contract and become stronger. Studies have found that NMES enhances balance, which is crucial for fall prevention. It is especially beneficial for those who struggle with regular exercise due to muscle weakness. This trial will compare NMES combined with a multi-modality balance intervention (MMBI) to MMBI alone. Overall, NMES offers a promising method to help older individuals improve balance and reduce fall risk. ^{4 6 7 8 9}

Who Is on the Research Team?

Odessa R. Addison, PhD DPT

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Are You a Good Fit for This Trial?

This trial is for individuals who are 55 years or older and at high risk of falling. It's not suitable for those with poorly controlled hypertension, home oxygen use, conditions that make resistance exercise or NMES use unsafe, dementia, or any other medical condition that the study team believes would interfere with participation.

Inclusion Criteria

I am 55 years old or older.

I am at risk of falling.

Exclusion Criteria

My high blood pressure is not well-managed.

Contraindications to resistance exercise

Home oxygen use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neuromuscular electrical stimulation (NMES) applied to hip abductors along with a multi-modality balance intervention

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of balance and muscle composition

12 months

Periodic assessments (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Multi-Modality Balance Intervention (MMBI)
• Neuromuscular electrical stimulation (NMES)

Trial Overview The study tests a new program combining neuromuscular electrical stimulation (NMES) on hip muscles with balance and strengthening exercises to improve balance and mobility in order to reduce fall risks in older adults.

How Is the Trial Designed?

Group I: NMES + MMBI Experimental Treatment 2 Interventions

Neuromuscular electrical stimulation applied to hip abductors along with participation in a multi-modality balance intervention

Group II: MMBI Active Control 1 Intervention

Participation in a multi-modality balance intervention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The combination of electromyostimulation (EMS) and the static exercise 'tilt to the side' significantly improved postural balance in healthy adolescents, as measured by the displacement of the center of mass in both frontal and sagittal planes.

While EMS enhanced muscle relaxation and control during the exercise, no immediate improvements in travel speed or area of statokinesigram were observed, likely due to the unfamiliarity with the exercise and the static nature of the posture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An influence of combined use of electromyostimulation and static postures on the main characteristics of postural balance]. Gusarov, AV., Rostovtsev, VL., Safonov, LV., et al.[2020]

In a study involving 15 subjects, neuromuscular electrical stimulation (NMES) with a pulse duration of 500 μs was tolerated better than 200 μs, allowing for greater muscle torque at 49.3% of maximum voluntary isometric contraction (MVIC) compared to 44.5% (p=0.02).

This suggests that longer pulse durations may enhance patient comfort and potentially improve the effectiveness of NMES in treating muscle weakness, although further research is needed to determine if these differences translate into significant strength gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation pulse duration and maximum tolerated muscle torque. Scott, W., Flora, K., Kitchin, BJ., et al.[2014]

Neuromuscular electrical stimulation (NMES) therapy, when added to usual care, is effective in preventing skeletal-muscle weakness in critically ill patients, as shown in a systematic review of 8 studies involving 172 patients.

While NMES demonstrated benefits in preserving muscle strength, the evidence for its effectiveness in preventing muscle wasting remains inconclusive, with mixed results across the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation for preventing skeletal-muscle weakness and wasting in critically ill patients: a systematic review. Maffiuletti, NA., Roig, M., Karatzanos, E., et al.[2022]

The neuromuscular electrical stimulation (NMES) protocol applied to critical ill patients was found to be safe, with no significant changes in muscle damage markers (creatine phosphokinase) or other safety indicators (central venous oxygen saturation and serum lactate) over the study period.

The NMES protocol was also feasible, with patients completing 85% of the planned sessions in an average time of 107 minutes, indicating that this treatment can be effectively integrated into the care of critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of a neuromuscular electrical stimulation chronaxie-based protocol in critical ill patients: A prospective observational study. Silva, PE., Babault, N., Mazullo, JB., et al.[2018]

Neuromuscular electrical stimulation (NMES) significantly improves lower limb motor function in chronic stroke survivors, with a moderate effect size based on a review of 21 randomized controlled trials involving 1481 participants.

NMES also enhances gait speed, balance, spasticity, and range of motion, making it a promising therapy for rehabilitation, although it does not significantly improve walking endurance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Neuromuscular Electrical Stimulation on Lower Limbs of Patients With Hemiplegia After Chronic Stroke: A Systematic Review. Hong, Z., Sui, M., Zhuang, Z., et al.[2019]

A 12-week neuromuscular electrical stimulation (NMES) program significantly increased plantar flexor strength by 47% in older adults, which was statistically significant (P = .02).

The increase in muscle strength directly improved the limits of stability by 27%, indicating that NMES can be an effective intervention for enhancing stability and potentially preventing falls in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plantar Flexor Strength Training With Home-Based Neuromuscular Electrical Stimulation Improves Limits of Postural Stability in Older Adults. Langeard, A., Bigot, L., Loggia, G., et al.[2020]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40312027/?utm_source=Inoreader&utm_medium=rss&utm_campaign=None&utm_content=1v7eLHwZVcQyuFzvfc9ddhAtOlNpnOIj7KtfT9uAgqUo08okrO&fc=None&ff=20250502092257&v=2.18.0.post9+e462414

Neuromuscular Electrical Stimulation to Maximize Hip ... Primary outcomes include fall risk and dynamic balance, measured by FSST and hip abductor strength using a Biodex dynamometer. Secondary ...

2. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2024.1507402/full

achieving physical activity benefits for all abilities NMES has, especially among older and/or untrained individuals, been shown to provide effective muscle activation, resulting in improved muscle ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0378512218301580

The use of neuromuscular electrical stimulation (NMES) for ... NMES may benefit older adults with functional deficits by improving muscle strength, exercise tolerance and functional independence.

4. withpower.com withpower.com/trial/nmes-for-reducing-fall-risk-a5a00

NMES for Reducing Fall Risk Research shows that neuromuscular electrical stimulation (NMES) can improve muscle strength and postural stability, which are important for reducing fall risk.

5. ctv.veeva.com ctv.veeva.com/study/reducing-fall-risk-with-nmes

Reducing Fall Risk With NMES - ClinicalTrials.Veeva This study will test the additive effect of NMES applied to the hip muscles during a balance and strengthening program to improve balance and mobility, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5683854/

Neuromuscular Electrical Stimulation for Treatment of Muscle ... Can be safely and comfortably applied within 24–72 h post-stroke. NMES can reduce existing sublux even 6 mo post-stroke; however, the likelihood of improvement ...

7. researchprotocols.org researchprotocols.org/2025/1/e68082

Neuromuscular Electrical Stimulation to Maximize Hip ... This trial will be the first large, randomized controlled trial to evaluate NMES as an adjunct to an MMBI for fall prevention in older veterans.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6031422/

Safety of neuromuscular electrical stimulation among critically ... Neuromuscular electrical stimulation is safe for critically ill patients; however, it should be applied by duly trained professionals and with proper evidence- ...

9. 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.