Effect of NMES on Balance and Fall Risk in Chronic Stroke

NCT04957355 | Recruiting FDA Device

• 1 other identifier: 2021-0408
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Laboratory Falls

  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.

  Baseline (1st Novel slip/trip, Session 2, Week 1)

Secondary Outcomes (11)

• Reactive (post-slip) Stability

  Baseline (1st Novel slip/trip, Session 2, Week 1)

• Pre-slip Stability

  Baseline (1st Novel slip/trip, Session 2, Week 1)

• Vertical limb support

  Baseline (1st Novel slip/trip, Session 2, Week 1)

• Compensatory step length

  Baseline (Session 2, Week 1)

• Compensatory step initiation time

  Baseline (Session 2, Week 1)

Study Arms (1)

Effect of functional electrical stimulation on reactive balance and laboratory falls

EXPERIMENTAL

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.

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

Interventions

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

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)

Effect of functional electrical stimulation on reactive balance and laboratory falls

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (1)

• Purohit R, Varas-Diaz G, Bhatt T. Functional electrical stimulation to enhance reactive balance among people with hemiparetic stroke. Exp Brain Res. 2024 Mar;242(3):559-570. doi: 10.1007/s00221-023-06729-z. Epub 2024 Jan 12.

  PMID: 38214733 DERIVED

Study Officials

• Tanvi Bhatt, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rudri M Purohit, MS,PT

CONTACT

3124139772; rpuroh2@uic.edu

Lakshmi Kannan, MS,PT

CONTACT

3124133175; lkanna2@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single group design to compare the effects of neuromuscular electrical stimulation on reactive balance control, gait, and fall risk in individuals with chronic stroke

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 12, 2021
• Study Start: May 15, 2021
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)