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New treatment option for Stroke, Ischemic
Official title The REACTplusNMES Trial: A Double-blinded RCT
ClinicalTrials.gov ID: NCT06127602
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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.
You likely can't join if
- people will not proceed with the test if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate...
- 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...
- Severe osteoporosis (indicated by T score \< -2)
- Cognitive impairment (indicated by Mini-Mental State Exam score\<25)
See the full eligibility 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).
- people 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...
- 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).
- people with Chedoke McMaster Leg Assessment Scale score (\> 4).
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.