Effect of NMES on Balance and Fall Risk in Chronic Stroke

Recruiting now · Not applicable

Conditions studied: Chronic Stroke

In brief

The aim of this study is to describe the effect of neuromuscular electrical stimulation (NMES) in the form of functional electrical stimulation (FES) applied to different lower limb muscles on reactive balance and gait performance in stroke participants. Methods: Twenty individuals with chronic stroke will be asked to perform an experimental protocol that includes a postural disturbance in the form of a slip- or trip-like perturbation and a standardized walking test in both laboratory and outdoor environments with and without FES applied to different lower limb muscles of the paretic leg. FES will be applied using an advanced software that is able to synchronize muscle activation with the time of perturbation onset and according to the phases of gait. This project design aims to examine whether a specific pattern of lower limb muscle stimulation could improve the kinematic and behavioral responses during reactive balance following slip- and trip-like perturbations. Additionally, the project aims to see if the kinematic and spatio-temporal gait parameters can be modified during a standardized walking test under different sensory and environmental conditions.

Key facts

Study ID

NCT04957355

Run by

University of Illinois at Chicago

People needed

20

Starts

2021-05-15

Expected to finish

2027-11-30

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age group: 18-90 years.
• Presence of hemiparesis.
• Onset of stroke (> 6 months).
• Ability to walk independently with or without an assistive device for at least 300 ft.
• Can understand and communicate in English.
• Cognitively and behaviorally capable of complying with the regimen (Montreal Cognitive Assessment > 25/30).

You may not qualify if…

• 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.
• Body weight more than 250 lbs.
• Any neurological condition other than stroke.
• Any cardiopulmonary, musculoskeletal, or systemic diagnosis.
• Recent major surgery (< 6 months) or hospitalization (< 3 months).
• Deep venous thrombosis.
• Antecedent of cancer.
• Peripheral nerve injury or neuropathy in the affected limb with motor disability.
• Spasticity (Ashworth scale > 2).
• Uncontrolled high blood pressure/angina.
• Skin condition not tolerant with FES therapy.
• Uncontrolled seizure disorder.
• Botox treatment within the last 5 months.
• History of epilepsy.
• Pacemaker users.
• Excluded or Vulnerable Populations Non-English speaking populations will be excluded as the consent procedures and instructions will be in English.

Where it is running

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

Full record on ClinicalTrials.gov

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