NCT04957355 · University of Illinois at Chicago
Effect of NMES on Balance and Fall Risk in Chronic Stroke
(NMES)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Neuromuscular electrical stimulation (NMES) or Functional electrical stimulation (FES)
Stance and Walk-Perturbation Training Protocol ActiveStep and Surefooted Protocol: Perturbation training protocol with and without FES Participants will be asked to perform a postural disturbance protocol in the stance position and walk in the form of 7 slips and 7 trips with two retention trials after the training using the ActiveStep treadmill system while fitted in a safety harness. All perturbations will be delivered at each participant's comfortable walking speed. Similar slip and trip training in walking will be conducted on the surefooted platform with and without FES. Gait Training Protocol and Surefooted protocol Participants will be asked to perform a 10m walking test (walking for a distance of 45 feet) in a laboratory environment six times (three times with and without FES) and in an outdoor environment located in the parking lot of the Applied Health Science building (1919 W. Taylor St., Chicago, IL)
Primary outcome measures
Laboratory Falls
Time frame: Baseline (1st Novel slip/trip, Session 2, Week 1)
The outcome of a perturbation trial is dichotomous with #1 being a fall, which is assigned if the force detected by the load-cell exceeded 30% of the participant's body weight after perturbation or if the researcher assists the participant to attain a standing position following perturbation. Otherwise, the outcome is regarded as a non-fall (#0). Laboratory falls are reported in percentage (%), defined as the number of falls experienced during perturbation trials related to the total number of perturbation trials.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
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.
- 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
- Chicago, Illinois
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Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations