Using electrical stimulation to improve balance and reduce fall risk in stroke patients

Effect of Neuromuscular Electrical Stimulation (NMES) on Reactive Balance, Gait and Fall-risk in Individuals with Stroke

This study is testing if using electrical stimulation on leg muscles can help stroke patients improve their balance and reduce their risk of falling.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: University of Illinois at Chicago (other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT04957355 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of neuromuscular electrical stimulation (NMES) on balance and gait performance in individuals with chronic stroke. Participants will undergo a series of tests involving postural disturbances and walking assessments, both with and without the application of NMES to their lower limb muscles. The goal is to determine if targeted muscle stimulation can enhance their ability to respond to slips and trips, thereby improving their overall mobility and reducing fall risk.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-90 with chronic hemiparesis following a stroke that occurred more than six months prior.

Not a fit: Patients with other neurological conditions, significant cardiopulmonary issues, or those who are unable to walk independently may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance balance and mobility in stroke survivors, leading to a reduced risk of falls.

How similar studies have performed: Previous studies have shown promising results with functional electrical stimulation in improving gait and reducing fall risk in stroke patients, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

Age group: 18-90 years.

1. Presence of hemiparesis.
2. Onset of stroke (\> 6 months).
3. Ability to walk independently with or without an assistive device for at least 300 ft.
4. Can understand and communicate in English.
5. Cognitively and behaviorally capable of complying with the regimen (Montreal Cognitive Assessment \> 25/30).

Exclusion Criteria:

Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during rest, or 3) oxygen saturation (measured by pulse oximeter) \< 95% during rest.

1. Body weight more than 250 lbs.
2. Any neurological condition other than stroke.
3. Any cardiopulmonary, musculoskeletal, or systemic diagnosis.
4. Recent major surgery (\< 6 months) or hospitalization (\< 3 months).
5. Deep venous thrombosis.
6. Antecedent of cancer.
7. Peripheral nerve injury or neuropathy in the affected limb with motor disability.
8. Spasticity (Ashworth scale \> 2).
9. Uncontrolled high blood pressure/angina.
10. Skin condition not tolerant with FES therapy.
11. Uncontrolled seizure disorder.
12. Botox treatment within the last 5 months.
13. History of epilepsy.
14. Pacemaker users.

Excluded or Vulnerable Populations Non-English speaking populations will be excluded as the consent procedures and instructions will be in English.

Where this trial is running

Chicago, Illinois

• University of Illinois at Chicago — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Tanvi Bhatt, PhD — University of Illinois at Chicago
• Study coordinator: Rudri M Purohit, MS,PT

Conditions: Chronic Stroke, functional electrical stimulation, neuromuscular electrical stimulation, walk-training, treadmill training, reactive balance, perturbation, falls