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

Trial Summary

What is the purpose of this trial?

Falls are dangerous leading to injuries, hospital admissions and even death. Fall prevention is a priority but effective programs only reduce falls by 30%. Weak hip muscles may be one reasons individuals experience a loss of balance. However individuals who have weak hip muscles may be unable to exercise at sufficient intensities to improve their hip muscle strength. The purpose of this study is to utilize a common physical therapy method, neuromuscular electrical stimulation (NMES), on the hip muscles to improve hip muscle strength and improve balance. The new program focuses on using NMES during a resistance training program along with exercise to improve standing balance, walking and stepping over objects. 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 ultimately reduce the risk of falls in older Veterans at high risk for falls.

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 data supports the effectiveness of the treatment 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. For example, NMES has been found to enhance muscle strength in older adults and improve postural balance when combined with static exercises. ^{1 2 3 4 5}

Is neuromuscular electrical stimulation (NMES) generally safe for humans?

Research indicates that NMES is generally safe, but patient discomfort can limit its use. A study on critically ill patients found NMES to be safe and feasible, suggesting it can be used in various conditions with proper monitoring. ^{2 3 4 6 7}

How is the NMES treatment for reducing fall risk different from other treatments?

The NMES treatment is unique because it uses electrical impulses to stimulate muscles, which can improve muscle strength and balance, particularly in older adults. This approach is different from other treatments as it directly targets muscle weakness and postural stability, which are key factors in reducing fall risk. ^{1 2 3 4 6}

Research Team

Odessa R. Addison, PhD DPT

Principal Investigator

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[An influence of combined use of electromyostimulation and static postures on the main characteristics of postural balance]. [2020]

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

Plantar Flexor Strength Training With Home-Based Neuromuscular Electrical Stimulation Improves Limits of Postural Stability in Older Adults. [2020]

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

Neuromuscular electrical stimulation for preventing skeletal-muscle weakness and wasting in critically ill patients: a systematic review. [2022]

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

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

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

Effectiveness of Neuromuscular Electrical Stimulation on Lower Limbs of Patients With Hemiplegia After Chronic Stroke: A Systematic Review. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation pulse duration and maximum tolerated muscle torque. [2014]

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

Safety and feasibility of a neuromuscular electrical stimulation chronaxie-based protocol in critical ill patients: A prospective observational study. [2018]