Functional electrical stimulation for improving gait in persons with chronic stroke.
Shelialah Pereira, Swati Mehta, Amanda McIntyre...
https://pubmed.ncbi.nlm.nih.gov/23192714/Actively Recruiting
Led by University of Illinois at Chicago · Updated on 2026-07-07
46
Participants Needed
1
Research Sites
13 weeks
Total Duration
Researchers are evaluating reactive balance training combined with neuromuscular electrical stimulation NMES to improve balance control in people with chronic stroke who have moderate to severe motor impairment. This Phase I, double-blinded, randomized controlled trial compares the effects of 6 weeks of reactive balance training REACT alone versus REACT combined with NMES on biomechanical, clinical, neuromuscular, and neuroplastic outcomes related to reactive balance control. Participants will be randomly assigned to one of two groups the intervention group receives REACT with NMES applied to the paretic lower limb muscles, while the control group receives REACT with sham NMES. Both groups will complete 12 one-hour training sessions over 6 weeks 2 sessions per week. NMES synchronization is controlled by a footswitch on the paretic shoe and is delivered during perturbations mimicking slips. The control group receives low-intensity sham stimulation to prevent unblinding. Participants will undergo initial screening and pre-training assessments including walking tests and laboratory-induced slips or trips to measure balance responses. After the 6-week training, post-training assessments will repeat these tests to evaluate changes. Researchers will measure changes in falls, reactive and proactive stability, muscle activation patterns, neuroplastic brain activity, and clinical balance and gait outcomes. The study lasts approximately 9 weeks per participant and includes detailed monitoring to understand immediate therapeutic effects and underlying mechanisms.
CONDITIONS
The REACTplusNMES Trial: A Double-blinded RCT
R
Rudri Purohit, MS
S
Swaranka Deshmukh, MS
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University of Illinois at Chicago
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Reactive Balance Training With Neuromuscular Electrical Stimulation | Reactive Balance Training Without Neuromuscular Electrical Stimulation |
|---|---|---|
| What it is | Progressive slip-perturbation treadmill training where participants receive neuromuscular electrical stimulation (NMES) to the vastus lateralis at each slip event. | Identical slip-perturbation treadmill training, but participants receive sham NMES (inactive stimulation) after the compensatory step. |
| Role in the trial | Intervention group assessing whether NMES during slips improves fall resistance and stability. | Comparator group to isolate the effect of NMES by using identical training with sham stimulation. |
| Primary use | To investigate whether NMES during reactive balance training enhances fall resistance, stability, and motor adaptation in chronic stroke patients. | To assess fall resistance and stability outcomes from standard reactive balance training without NMES in chronic stroke patients. |
| How it is given or performed | Participants walk on the ActiveStep treadmill and undergo slip perturbations. NMES is delivered to the vastus lateralis muscle 50 ms after slip onset, lasting 450 ms during compensatory step motion. Training progresses from mild to severe slips over 12 sessions. | Participants undergo identical treadmill slip perturbations and protocol progression. Sham NMES (inactive stimulation) is applied after compensatory step touchdown, mimicking the time structure without NMES. |
| Evidence status | Evidence for NMES during reactive balance training in stroke is limited to pilot studies and ongoing clinical investigation. Prior pilot study suggests potential improvement in balance control and fall resistance, but larger clinical trial outcomes are not yet established. | Published evidence supports that slip-perturbation treadmill training improves fall resistance and stability in people with chronic stroke, but the impact without NMES compared to NMES-enhanced protocols remains under investigation. |
| Important limitations | Evidence for NMES application during slip-perturbation training is limited to small pilot studies. The optimal stimulation parameters and long-term effectiveness remain uncertain, and safety data for repeated NMES during treadmill slips is sparse. | Slip-perturbation treadmill training without NMES is established as beneficial for fall resistance and stability, but lacks NMES-specific enhancement. Some participants may not fully benefit if motor adaptation capacity is limited, and risk reduction compared to NMES protocols remains to be formally tested. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (2 hours)
Duration - 1 week
Participants complete baseline tests including walking and balance tests with induced slips or trips in the lab.
1 visit (4 hours)
Duration - 6 weeks
Participants undergo 6 weeks of reactive balance training, with or without synchronized electrical stimulation, in 12 one-hour sessions twice a week.
12 visits (1 hour each, twice per week)
Duration - 1 week
Participants repeat walking and balance tests to measure changes after training.
1 visit (4 hours)
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/34609544/University of Illinois at Chicago
Lead Sponsor