Recruiting

Observational Study

Sponsor:

University of Illinois at Chicago

Code:

NCT06127602

Conditions

Stroke, Ischemic

Stroke Hemorrhagic

Stroke, Cerebrovascular

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Reactive balance training with Neuromuscular Electrical Stimulation

Reactive balance training without Neuromuscular Electrical Stimulation

Study Details

Brief summary:

The aim of this study is to compare the effectiveness of 6-weeks of reactive balance training (REACT) with and without neuromuscular electrical stimulation (NMES) to paretic lower limb muscles on biomechanical, clinical, neuromuscular and neuroplastic outcomes of reactive balance control. This project is a Phase-I study and incorporates a double-blinded, randomized controlled trial design.

Methods: Forty-six individuals with chronic stroke will be recruited and screened for determining their eligibility for the study. Once enrolled, they will be randomized into either of the two groups: intervention group (23 participants) and control group (23 participants). Both groups will undergo series of pre-training assessments which includes a postural disturbance in the form of a slip- or trip-like perturbations and walking tests in laboratory environment. After the pre-training assessment, individuals will undergo 6-weeks of training (2 hour per session, 2 sessions per week). The intervention group will receive NMES with the REACT training and the control group will receive ShamNMES. NMES will be applied to the different muscle groups of the paretic lower limb using an advanced software which is able to synchronize muscle activation with the time of perturbation onset and according to the phases of gait. After training, both groups will again be tested on all the assessments performed pre training.

This study will help us understand the immediate therapeutic and mechanistic effects of REACT+NMES and inform stroke rehabilitation research and clinical practice. Our study will provide foundational evidence for future use of NMES to implement clinically applicable neuromodulation adjuvants to reactive balance training, which could be leveraged for designing more effective future interventions for fall-risk reduction.

Conditions

Stroke, Ischemic

Stroke Hemorrhagic

Stroke, Cerebrovascular

Study ID

NCT06127602

Start date

Mar 1, 2024

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age group: 18-90 years.
  • Presence of hemiparesis.
  • Onset of stroke (> 6 months).
  • Ability to walk at least for 2 minutes on the treadmill with or without ankle foot orthosis.
  • Can understand and communicate in English.
  • Cognitively and behaviorally capable of complying with the regimen (Mini-Mental State Examination > 25/30).
  • No history or recent use (i.e., past 6 weeks) of any Neuromuscular electrical stimulation device to leg muscles during walking (e.g., Bioness, Walkaide).

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 of more than 250 lbs.
  • Spasticity (Ashworth scale > 2).
  • Loss of protective sensations on the paretic leg (indicated by inability to perceive the 5.07/10 g on Semmes-Weinstein Monofilament) or inability to feel the NMES.
  • Severe osteoporosis (indicated by T score < -2)
  • Cognitive impairment (indicated by Mini-Mental State Exam score<25)
  • Global Aphasia (indicated by <71% on the Mississippi Aphasia Screening Test).
  • Subjects with Chedoke McMaster Leg Assessment Scale score (> 4).

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: REACT-NMES: Intervention condition

The REACT-NMES group will undergo 6 weeks of reactive balance training with NMES involving 12 one-hour sessions (twice a week). Each session will begin with NMES parameter setup where the current amplitude will be customized to individual "maximal tolerable" levels for a strong yet comfortable experience. NMES settings will include moderate to high intensity (30-50mA) and low frequency (20-45Hz) to target motor nerve thresholds. The REACT-NMES group will wear a footswitch on their paretic shoe for triggering the slips during walking and for NMES synchronization. NMES will be delivered to the paretic limb quadriceps muscles for 500 milliseconds after slip onset.

active comparator: REACT: Control condition

The REACT group will undergo 6 weeks involving 12 one-hour sessions (twice a week) of reactive balance training with ShamNMES. To prevent psychological bias and unblinding, sub-sensory stimulation will be used. ShamNMES will employ low intensity (0-10mA) and high frequency (50-100Hz), staying 20% below the sensory nerve threshold without inducing muscle contraction. The REACT group will wear a footswitch on their paretic shoe for triggering the slips during walking and for ShamNMES synchronization. ShamNMES (control) will be delivered after compensatory step touchdown to avoid interference with balance recovery.

Interventions

Reactive balance training with Neuromuscular Electrical Stimulation

REACT-NMES group: The ActiveStep treadmill will be used to deliver slips during all sessions. Each subject will experience three levels of perturbations over 12 sessions (24 slips/session) in progressive ascending way. On the first week, subjects will start with the lowest displacement level (6 cm) and move up to the next level (12 cm) by week 2 if they have < 5 falls out of 8 slips at the previous level. By week 3, subjects are expected to move to level 3 (24 cm) and train at that for weeks 3 to 6. If subjects don't move up a level, training will continue at the lower level. NMES will be delivered to the vastus lateralis synchronously with the perturbation, which will always occur 50 ms after slip-onset and last for 450 ms including the period between liftoff to touchdown of the first compensatory step.

Reactive balance training without Neuromuscular Electrical Stimulation

REACT group: The REACT group will undergo the same reactive balance training (in terms of type, dosage: intensity, frequency) as the REACT-NMES group. The only difference will be that the REACT group will receive ShamNMES for same time after the compensatory step touchdown. The ActiveStep treadmill will be used to deliver slips during all sessions. Each subject will experience three levels of perturbations over 12 sessions (24 slips/session) in progressive ascending way. On the first week, subjects will start with the lowest displacement level (6 cm) and move up to the next level (12 cm) by week 2 if they have < 5 falls out of 8 slips at the previous level. By week 3, subjects are expected to move to level 3 (24 cm) and train at that for weeks 3 to 6. If subjects don't move up a level, training will continue at the lower level.

Primary outcome measure

  • Change in Falls [ Time Frame: Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16) ]
  • Change in Reactive Stability [ Time Frame: Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16) ]
  • Change in Proactive Stability [ Time Frame: Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16) ]
  • Change in Vertical Limb support [ Time Frame: Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16) ]
  • Change in Muscle synergies [ Time Frame: Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16) ]
  • Change in Perturbation-evoked potentials [ Time Frame: Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16) ]
  • Change in time-frequency power [ Time Frame: Pre-training (during week 2 i.e., Session 2), Post-training (during week 9 i.e., Session 16) ]

Central Contacts and Locations

Central contacts

Rudri Purohit, MS

312-413-9772rpuroh2@uic.edu

Swaranka Deshmukh, MS

312-355-3988sdeshm9@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Tanvi Bhatt, PhD

3123554443tbhatt6@uic.edu

Rudri Purohit, MS

312-413-9772rpuroh2@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Reactive balance
  • Falls
  • Perturbation training
  • NMES
  • FES
  • Stroke
  • Fall prevention
  • Neuroplastic
  • Neuromuscular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-07-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.