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Chronic StrokeNMESNCT04957355

Effect of NMES on Balance and Fall Risk in Chronic Stroke

A study testing Neuromuscular electrical stimulation (NMES) or Functional electrical stimulation (FES) in people with Chronic Stroke, run by University of Illinois Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Chronic Stroke
What is being tested?
Neuromuscular electrical stimulation (NMES) or Functional electrical stimulation (FES)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
15 May 2021to 30 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rudri M Purohit, MS,PT contact

3124139772

rpuroh2@uic.edu

Lakshmi Kannan, MS,PT contact

3124133175

lkanna2@uic.edu

United States1 site, 1 recruiting
  • University of Illinois at Chicago

    Chicago, Illinois, 60612

    Tanvi Bhatt, PhD, 3123554443, tbhatt6@uic.edu

    Rudri Purohit, MS, 3128773640, rpuroh2@uic.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

Functional impairment after a stroke often includes slowed gait velocity and increased fall risk attributed to foot drop (the inability to dorsiflex the ankle during the swing phase of gait) and lower limb muscle weakness. Damage in the motor cortex or corticospinal tract often results in significant, persistent distal muscle weakness, including the sensorimotor control of the ankle joint, typically because of a combination of weakness of the agonist ankle dorsiflexor muscles and spasticity of the antagonist plantar flexor muscle. This results in slower and abnormal gait which leads to gait compensation strategies such as hip hitching, excess circumduction during gait, reduced foot clearance, and high energy expenditure, all of which are factors which could increase the risk of falls in individuals with stroke.

Functional electrical stimulation (FES) corresponds to the application of an electric field across the motor neurons of a muscle to induce an artificial, involuntary contraction to perform a functional movement. Numerous benefits of FES have been reported throughout literature such as increased muscle mass, increased bone mineral density, and improved cardiovascular parameters, among others. Previous studies in which authors assessed the effect of FES on individuals with stroke have demonstrated that the common peroneal nerve stimulates the tibialis anterior muscle to produce foot dorsiflexion during the swing phase of the gait cycle and reduces foot drop by facilitating increased voluntary muscle activity, which together improves the quality and symmetry of gait. Additionally, others studies showed that FES improves walking speed and energy expenditure in individuals with stroke.

In the last years, FES systems have been used as neuroprosthetic devices in rehabilitative interventions such as gait training. Stimulator triggers, implemented to control stimulation delivery, range from open- to closed-loop controllers.12 Finite-state controllers trigger stimulators when specific conditions are met and utilize preset sequences of stimulation. Thus, wearable sensors provide the necessary input to differentiate gait phases during walking and trigger stimulation to specific muscles.13 This technology has been largely used to improve gait parameters in stroke participants, however, it has not been well described how this technology could help stroke participants during the loss of balance or during reactive balance.

On the other hand, the literature suggests that a direct transcortical loop does not trigger the initial phase of postural responses to external perturbations, but it seems likely that the cerebral cortex becomes involved in the later phases of the reactive response.14 Thus, given that postural response lasts for many hundreds of milliseconds, it may be that the brainstem or spinal cord circuits initiate a response, and then the response subsequently becomes modified by cortical circuits during its later phases.15 In this context, the effect of peripheral stimulation to the muscles involved in the reactive response to an unexpected external perturbation on recovery performance has not yet been described.

This project aims to describe whether a specific pattern of lower limb muscle stimulation could modify the recovery response after an unexpected perturbation in the form of a slip and/or trip in individuals with stroke. Also, this project aims to examine if a specific pattern of lower limb muscle stimulation provided by FES can modify kinematic and spatio-temporal gait parameters during a standardized walking test under different sensory conditions.

Conditions
Chronic Stroke
Being tested
Neuromuscular electrical stimulation (NMES) or Functional electrical stimulation (FES)
Keywords
functional electrical stimulation, neuromuscular electrical stimulation, walk-training, treadmill training, reactive balance, perturbation, falls, fall prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT04957355
Study groupRoleWhat they receive
Effect of functional electrical stimulation on reactive balance and laboratory fallsExperimentalAll 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.
Receives: Device: Neuromuscular electrical stimulation (NMES) or Functional electrical stimulation (FES)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (11)
  1. Reactive (post-slip) Stability

    Post-slip (reactive) stability is calculated from the COM state (position and velocity) and computed at the instance of the first compensatory limb touchdown post-slipping. Values < 0 indicated a greater possibility of experiencing backward loss of balance and vice versa for values > 0.

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

  2. Pre-slip Stability

    Pre-slip stability is calculated from the COM state (its position and velocity) and computed at the instance of slipping limb touchdown (before the perturbation onset).

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

  3. Vertical limb support

    Vertical limb support will be quantified by the hip height i.e., the vertical distance between the midpoint of bilateral hips to the floor (Zhip), which is determined from the anterior-superior iliac spine markers and normalized by each participant's body height. The hip height will be assessed at the instance of post-slip compensatory limb touchdown, which indicates the instance of maximal hip descent following perturbation. Higher hip height values indicate greater vertical limb support.

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

  4. Compensatory step length

    The step length will be assessed as the distance from slipping heel to non-slipping heel at the instance of recovery touchdown. A more negative step length indicated a longer backward compensatory step and vice versa.

    Measured: Baseline (Session 2, Week 1)

  5. Compensatory step initiation time

    The time taken for liftoff of the compensatory limb after the perturbation onset is termed as the compensatory step initiation time.

    Measured: Baseline (Session 2, Week 1)

  6. Compensatory step execution time

    The time taken from liftoff of the compensatory limb to its first touchdown is termed as the compensatory step execution time.

    Measured: Baseline (Session 2, Week 1)

  7. Number of compensatory steps

    Number of compensatory steps will be assessed as the number of steps required to regain balance following slip onset till the participants resume their regular gait pattern.

    Measured: Baseline (Session 2, Week 1)

  8. Medio-Lateral excursion of center of mass

    The peak excursion of the COM perpendicular to the walking direction.

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

  9. Center of mass excursion angle

    the deviation of the Center of mass relative to the sagittal plane

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

  10. Gait speed

    Gait speed will be measured in meters per second (m/s) via the GaitRite assessment mat and via the three-dimensional inertial triaxial sensors. Higher gait speed indicates better walking performance.

    Measured: Baseline (Session 2, Week 1)

  11. Walking cadence

    Cadence will be determined during walking performance with and without NMES via walking on the treadmill (activestep) and the GaitRite mat. Lower cadence indicate better performance.

    Measured: Baseline (Session 2, Week 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2021
  2. Study start15 May 2021
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single group design to compare the effects of neuromuscular electrical stimulation on reactive balance control, gait, and fall risk in individuals with chronic stroke
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04957355
Sponsor's protocol ID
2021-0408
Acronym
NMES
Status last verified
May 2026
First submitted
11 Jun 2021
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 38214733

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular electrical stimulation (NMES) or Functional electrical stimulation (FES) in people with Chronic Stroke, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rudri M Purohit, MS,PT (3124139772, rpuroh2@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Laboratory Falls (time frame: Baseline (1st Novel slip/trip, Session 2, Week 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04957355, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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