Balance Training with Electrical Stimulation for Stroke

(REACT+NMES Trial)

Overseen By Swaranka Deshmukh, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Spasticity, Severe osteoporosis, Cognitive impairment, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 15

Duration: 6 weeks

46 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to compare the effectiveness of 6-weeks of reactive balance training (REACT) with and without neuromuscular electrical stimulation (NMES) to paretic lower limb muscles on biomechanical, clinical, neuromuscular and neuroplastic outcomes of reactive balance control. This project is a Phase-I study and incorporates a double-blinded, randomized controlled trial design. Methods: Forty-six individuals with chronic stroke will be recruited and screened for determining their eligibility for the study. Once enrolled, they will be randomized into either of the two groups: intervention group (23 participants) and control group (23 participants). Both groups will undergo series of pre-training assessments which includes a postural disturbance in the form of a slip- or trip-like perturbations and walking tests in laboratory environment. After the pre-training assessment, individuals will undergo 6-weeks of training (2 hour per session, 2 sessions per week). The intervention group will receive NMES with the REACT training and the control group will receive ShamNMES. NMES will be applied to the different muscle groups of the paretic lower limb using an advanced software which is able to synchronize muscle activation with the time of perturbation onset and according to the phases of gait. After training, both groups will again be tested on all the assessments performed pre training. This study will help us understand the immediate therapeutic and mechanistic effects of REACT+NMES and inform stroke rehabilitation research and clinical practice. Our study will provide foundational evidence for future use of NMES to implement clinically applicable neuromodulation adjuvants to reactive balance training, which could be leveraged for designing more effective future interventions for fall-risk reduction.

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 Balance Training with Electrical Stimulation for Stroke?

Research shows that reactive balance training (RBT) can improve balance reactions in stroke patients, reducing fall risk. Additionally, balance training with electromyogram-triggered functional electrical stimulation (EMG-triggered FES) has been found to significantly enhance static and dynamic balance, as well as muscle activation in stroke patients, more than balance training alone. ^{1 2 3 4 5}

Is balance training with electrical stimulation safe for humans?

Neuromuscular electrical stimulation (NMES) has been used safely in various settings, including for people with spinal cord injuries and in healthy adults, to strengthen muscles and improve physical function. ^{6 7 8 9 10}

How does balance training with electrical stimulation differ from other stroke treatments?

This treatment combines balance training with neuromuscular electrical stimulation (NMES), which helps improve balance by electrically inducing muscle contractions that are difficult to achieve through voluntary effort alone. This approach is unique because it enhances both static and dynamic balance more effectively than balance training without electrical stimulation, offering a novel way to improve muscle activation and coordination in stroke patients. ^{2 3 11 12 13}

Research Team

Tanvi Bhatt

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for individuals aged 18-90 who have had a stroke at least 6 months ago, can walk on a treadmill for two minutes (with or without support), and are cognitively able to follow the study's procedures. They should not have used neuromuscular electrical stimulation devices recently.

Inclusion Criteria

I can walk on a treadmill for at least 2 minutes, with or without support for my ankle.

I haven't used devices like Bioness or Walkaide for leg muscle stimulation in the last 6 weeks.

I have weakness on one side of my body.

Exclusion Criteria

My muscle stiffness is moderate to severe.

Severe osteoporosis (indicated by T score < -2)

Loss of protective sensations on the paretic leg (indicated by inability to perceive the 5.07/10 g on Semmes-Weinstein Monofilament) or inability to feel the NMES

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-training Assessment

Participants undergo pre-training assessments including postural disturbance and walking tests

1 week

1 visit (in-person)

Treatment

Participants receive 6 weeks of reactive balance training with or without NMES

6 weeks

12 visits (in-person, 2 times/week)

Post-training Assessment

Participants undergo post-training assessments including all tests performed pre-training

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Reactive balance training with Neuromuscular Electrical Stimulation
• Reactive balance training without Neuromuscular Electrical Stimulation

Trial Overview The REACTplusNMES Trial is testing whether adding Neuromuscular Electrical Stimulation (NMES) to reactive balance training helps improve balance control in people with chronic stroke. Participants will be randomly assigned to either the intervention group with NMES or a control group without it.

Participant Groups

Group I: REACT-NMES: Intervention condition Experimental Treatment 1 Intervention

The REACT-NMES group will undergo 6 weeks of reactive balance training with NMES involving 12 one-hour sessions (twice a week). Each session will begin with NMES parameter setup where the current amplitude will be customized to individual "maximal tolerable" levels for a strong yet comfortable experience. NMES settings will include moderate to high intensity (30-50mA) and low frequency (20-45Hz) to target motor nerve thresholds. The REACT-NMES group will wear a footswitch on their paretic shoe for triggering the slips during walking and for NMES synchronization. NMES will be delivered to the paretic limb quadriceps muscles for 500 milliseconds after slip onset.

Group II: REACT: Control condition Active Control 1 Intervention

The REACT group will undergo 6 weeks involving 12 one-hour sessions (twice a week) of reactive balance training with ShamNMES. To prevent psychological bias and unblinding, sub-sensory stimulation will be used. ShamNMES will employ low intensity (0-10mA) and high frequency (50-100Hz), staying 20% below the sensory nerve threshold without inducing muscle contraction. The REACT group will wear a footswitch on their paretic shoe for triggering the slips during walking and for ShamNMES synchronization. ShamNMES (control) will be delivered after compensatory step touchdown to avoid interference with balance recovery.

Reactive balance training with Neuromuscular Electrical Stimulation is already approved in United States, European Union, Canada, Japan, China for the following indications:

Approved in United States as NMES for:

• Muscle strengthening
• Muscle reeducation
• Pain relief
• Edema reduction

Approved in European Union as NMES for:

• Muscle strengthening
• Muscle reeducation
• Pain relief
• Edema reduction
• Neurological rehabilitation

Approved in Canada as NMES for:

• Muscle strengthening
• Muscle reeducation
• Pain relief
• Edema reduction

Approved in Japan as NMES for:

• Muscle strengthening
• Muscle reeducation
• Pain relief
• Edema reduction
• Neurological rehabilitation

Approved in China as NMES for:

• Muscle strengthening
• Muscle reeducation
• Pain relief
• Edema reduction
• Neurological rehabilitation

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Findings from Research

Reactive balance training (RBT) significantly improved balance reaction impairments in individuals with sub-acute stroke, showing better outcomes in foot-off times and reduced reliance on preferred limb stepping compared to traditional balance training.

The study demonstrated that RBT not only led to immediate improvements post-intervention but also maintained these benefits at a 6-month follow-up, supporting its effectiveness in inpatient rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in balance reaction impairments following reactive balance training in individuals with sub-acute stroke: A prospective cohort study with historical control. Schinkel-Ivy, A., Huntley, AH., Danells, CJ., et al.[2021]

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]

A case study of a chronic stroke patient using the BalanceTrainer showed that sensory electrical stimulation during balance training significantly improved the patient's ability to maintain balance.

The patient experienced the greatest improvements in balance during the second training period, which included electrical stimulation of specific leg muscles, highlighting the potential efficacy of combining sensory stimulation with balance training for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic balance training with sensory electrical stimulation in chronic stroke patients. Worms, G., Matjacić, Z., Gollee, H., et al.[2020]

A study involving 32 participants with mild hemiparesis showed that Computerized Balance Training, combined with conventional physiotherapy, significantly improved balance and walking endurance compared to conventional therapy alone.

The experimental group demonstrated statistically significant improvements in various balance and mobility assessments, including the Berg Balance Scale and Two Minutes Walk Test, indicating that early intervention with Computerized Balance Training can enhance rehabilitation outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early balance training with a computerized stabilometric platform in persons with mild hemiparesis in subacute stroke phase: A randomized controlled pilot study. Brunelli, S., Gentileschi, N., Iosa, M., et al.[2021]

In a study involving 30 post-stroke hemiplegic patients, neuromuscular electrical stimulation (NMES) applied to both abdominal and back muscles significantly improved postural balance compared to a control group that only performed core muscle-strengthening exercises.

The improvements in balance, measured by the Korean version of the Berg Balance Scale and the Trunk Impairment Scale, were similar for both NMES groups, suggesting that NMES to the abdominal muscles could be a safe alternative for patients who cannot use NMES on their back muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Between Neuromuscular Electrical Stimulation to Abdominal and Back Muscles on Postural Balance in Post-stroke Hemiplegic Patients. Park, M., Seok, H., Kim, SH., et al.[2020]

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]

In a study involving 43 patients with chronic stroke, the hybrid treatment combining neuromuscular electrical stimulation (NMES) and noxious thermal stimulation (NTS) showed significant improvements in upper extremity recovery, as measured by the Fugl-Meyer assessment, compared to baseline.

However, the hybrid approach did not demonstrate superior efficacy over NMES or NTS alone, suggesting that while it is beneficial, it may not provide additional advantages beyond the individual treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the hybrid of neuromuscular electrical stimulation and noxious thermal stimulation on upper extremity motor recovery in patients with stroke: a randomized controlled trial. Chen, CC., Tang, YC., Hsu, MJ., et al.[2019]

The study found that low-intensity resistance training combined with neuromuscular electrical stimulation (RT + NMES) is safe for healthy adults, showing no excessive autonomic or cardiovascular responses during exercise.

Twenty healthy male college students participated in the trial, and results indicated that both RT and RT + NMES increased heart rate variability and blood pressure without significant differences between the two methods, suggesting that RT + NMES can be effectively implemented without safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of low-intensity resistance training combined with neuromuscular electrical stimulation on autonomic activity in healthy adults: A randomized controlled cross-over trial. Kutsuna, T., Sugawara, H., Kurita, H., 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]

Neuromuscular electrical stimulation (NMES) can significantly improve gait coordination in stroke survivors by inducing muscle contractions that help restore normal movement patterns, which are often impaired after a stroke.

Training with implanted NMES systems is more effective than traditional gait training without stimulation, as it enhances volitional coordinated gait components, leading to better overall mobility and reduced risk of falls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response of gait deficits to neuromuscular electrical stimulation for stroke survivors. Daly, JJ.[2007]

High-intensity electrical muscle stimulation (EMS) effectively induces sensory reweighting dynamics, improving postural balance in participants, as shown by a strong negative correlation between visual reweighting and balance sway in the EMS group.

Low-intensity electrotactile stimulation (ETS) did not significantly impact postural control, indicating that higher intensity stimulation is necessary for effective sensory reweighting during balance training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Stimulation Intensity to Induce Sensory Reweighting Dynamics While Standing on Balance Board. Shindo, M., Isezaki, T., Aoki, R.[2023]

In a study of 32 women aged 62 to 75, all three exercise programs (stair climbing, electrostimulation, and a combination of both) improved dynamic balance after 6 weeks, indicating that physical activity is beneficial for balance in older adults.

However, the stair climbing group showed a greater reliance on visual information for balance control, suggesting that voluntary exercise may be more effective than electrostimulation in enhancing balance strategies among the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of electrical stimulation superimposed on muscular voluntary contraction in postural control in elderly women. Paillard, T., Lafont, C., Soulat, JM., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Improvements in balance reaction impairments following reactive balance training in individuals with sub-acute stroke: A prospective cohort study with historical control. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Dynamic balance training with sensory electrical stimulation in chronic stroke patients. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Early balance training with a computerized stabilometric platform in persons with mild hemiparesis in subacute stroke phase: A randomized controlled pilot study. [2021]

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

Comparison Between Neuromuscular Electrical Stimulation to Abdominal and Back Muscles on Postural Balance in Post-stroke Hemiplegic Patients. [2020]

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. England pubmed.ncbi.nlm.nih.gov

Effects of the hybrid of neuromuscular electrical stimulation and noxious thermal stimulation on upper extremity motor recovery in patients with stroke: a randomized controlled trial. [2019]

9. Singapore pubmed.ncbi.nlm.nih.gov

The influence of low-intensity resistance training combined with neuromuscular electrical stimulation on autonomic activity in healthy adults: A randomized controlled cross-over trial. [2022]

10. 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]

11. England pubmed.ncbi.nlm.nih.gov

Response of gait deficits to neuromuscular electrical stimulation for stroke survivors. [2007]

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

Electrical Stimulation Intensity to Induce Sensory Reweighting Dynamics While Standing on Balance Board. [2023]

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

Short-term effects of electrical stimulation superimposed on muscular voluntary contraction in postural control in elderly women. [2016]