Recruiting

NMES

Sponsor:

University of Illinois at Chicago

Code:

NCT04957355

Conditions

Chronic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Neuromuscular electrical stimulation (NMES) or Functional electrical stimulation (FES)

Study Details

Brief summary:

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.

Conditions

Chronic Stroke

Study ID

NCT04957355

Start date

May 15, 2021

Status verified date

May, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Effect of functional electrical stimulation on reactive balance and laboratory falls

All individuals will be assigned to the experimental group and will undergo the testing and training procedure across two separate sessions. During the first session, the participants will go through the complete initial screening process. If eligible for the study, the participants will perform the experimental training protocols during the second session.

Experimental Protocol The quadriceps, hamstrings, tibialis anterior, gastrocnemius, and the trunk muscle group on the stroke-affected side (weaker side) will be stimulated according to the participant's comfort and tolerance. The range of the intensity allowed by the device is 0-50milliamperes (mA). The frequency of the electrical stimulation device ranges from 1-60Hz.

Interventions

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 measure

  • Laboratory Falls [ Time Frame: Baseline (1st Novel slip/trip, Session 2, Week 1) ]

Central Contacts and Locations

Central contacts

Rudri M Purohit, MS,PT

3124139772rpuroh2@uic.edu

Lakshmi Kannan, MS,PT

3124133175lkanna2@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Tanvi Bhatt, PhD

3123554443tbhatt6@uic.edu

Rudri Purohit, MS

3128773640rpuroh2@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • functional electrical stimulation
  • neuromuscular electrical stimulation
  • walk-training
  • treadmill training
  • reactive balance
  • perturbation
  • falls
  • fall prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-05-22.