Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID06127602

NeuroMuscular Electrical Stimulation to Enhance Reactive Balance Training for Fall Risk Reduction After Stroke: The REACTplusNMES Trial

Led by University of Illinois at Chicago · Updated on 2025-08-06

46

Participants Needed

1

Research Sites

13 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the effects of reactive balance training (REACT) with and without neuromuscular electrical stimulation (NMES) on individuals with chronic stroke who have moderate to severe motor impairment. This Phase-I study uses a double-blinded, randomized controlled trial design to compare biomechanical, clinical, neuromuscular, and neuroplastic outcomes of reactive balance control. The goal is to understand if adding NMES to REACT improves fall risk reduction and informs stroke rehabilitation strategies. Participants will be randomly assigned to one of two groups: the intervention group receiving REACT combined with NMES, and the control group receiving REACT with sham NMES. Both groups will undergo 6 weeks of training with two 1-hour sessions per week. NMES will be synchronized with perturbations during walking and applied to the paretic limb muscles in the intervention group, while the control group will receive low-level sham stimulation to mimic the experience without muscle contraction. Training involves progressive slip perturbations delivered via a treadmill, with intensity adjusted over the sessions. Participants will attend initial screening and pre-training assessments including tests of postural disturbance and walking. After completing 12 training sessions over 6 weeks, post-training assessments will repeat the same evaluations. Researchers will measure changes in falls, reactive and proactive stability, limb support, muscle activations, and neuroplastic responses. The total study involvement is about 9 weeks, including screening, training, and follow-up testing to assess the effects of the intervention.

CONDITIONS

Brief Title

The REACTplusNMES Trial: A Double-blinded RCT

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 90 years
  • Presence of hemiparesis (weakness on one side of the body)
  • Stroke onset more than 6 months ago
  • Ability to walk at least 2 minutes on a treadmill with or without ankle foot orthosis
  • Ability to understand and communicate in English
  • Cognitive and behavioral ability to comply with the study (Mini-Mental State Examination score over 25 out of 30)
  • No use of neuromuscular electrical stimulation devices on leg muscles during walking in the past 6 weeks
Not Eligible

You will not qualify if you...

  • Resting heart rate over 85% of age-predicted maximum, resting systolic blood pressure over 165 mmHg, or diastolic blood pressure over 110 mmHg
  • Resting oxygen saturation below 95%
  • Body weight over 250 lbs
  • Spasticity score over 2 on the Ashworth scale
  • Loss of protective sensation in the paretic leg or inability to feel neuromuscular electrical stimulation
  • Severe osteoporosis (T score below -2)
  • Cognitive impairment (Mini-Mental State Exam score below 25)
  • Global aphasia (score below 71% on Mississippi Aphasia Screening Test)
  • Chedoke McMaster Leg Assessment Scale score above 4

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Pre-training Assessment

Duration - 1 week

Participants undergo a comprehensive pre-training assessment including clinical, biomechanical, neuromuscular, and neuroplastic tests to establish baseline measures.

1 visit (in-person, approximately 4 hours)

Treatment

Duration - 6 weeks

Participants receive 6 weeks of in-lab reactive balance training with or without neuromuscular electrical stimulation to improve reactive balance control and reduce fall risk after stroke.

12 sessions (2 times per week, 1 to 2 hours per session)

Post-training Assessment

Duration - 1 week

Participants complete post-training assessments similar to pre-training to evaluate changes in reactive balance, clinical outcomes, and neuromuscular and neuroplastic measures.

1 visit (in-person, approximately 4 hours)

Trial Site Locations

Total: 1 location

1

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

R

Rudri Purohit, MS

S

Swaranka Deshmukh, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Application of neuromuscular electrical stimulation on the support limb during reactive balance control in persons with stroke: a pilot study.

Gonzalo Varas-Diaz, Tanvi Bhatt

https://pubmed.ncbi.nlm.nih.gov/34609544

Effect of Multisession Progressive Gait-Slip Training on Fall-Resisting Skills of People with Chronic Stroke: Examining Motor Adaptation in Reactive Stability.

Shamali Dusane, Tanvi Bhatt

https://pubmed.ncbi.nlm.nih.gov/34356128

The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review.

Anke I R Kottink, Linda J M Oostendorp, Jacob H Buurke...

https://pubmed.ncbi.nlm.nih.gov/15153151