Status:
RECRUITING
The REACTplusNMES Trial: A Double-blinded RCT
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Stroke, Ischemic
Stroke Hemorrhagic
Eligibility:
All Genders
18-90 years
Phase:
NA
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 biom...
Detailed Description
1.0 Background/Scientific Rationale Interventions such as conventional balance and exercise training constitute a major part of stroke rehabilitation and improve volitional balance control and gait in...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06127602
Start Date
March 1 2024
End Date
May 31 2026
Last Update
August 6 2025
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612