Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
72 participants
INTERVENTIONAL
2025-09-30
2030-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MINT group
MINT training of two leg muscles
myoelectric interface for neurorehabilitation (MINT) conditioning
Myoelectric interface for neurorehabilitation (MINT) conditioning involves training to reduce abnormal co-activation of limb muscles to improve movement.
Sham group
one muscle feedback
One muscle myoelectric feedback
Training to control muscle activity in one muscle only.
Interventions
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myoelectric interface for neurorehabilitation (MINT) conditioning
Myoelectric interface for neurorehabilitation (MINT) conditioning involves training to reduce abnormal co-activation of limb muscles to improve movement.
One muscle myoelectric feedback
Training to control muscle activity in one muscle only.
Eligibility Criteria
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Inclusion Criteria
* Leg impairment from unilateral stroke at least 6 months prior to screening
* Severe to moderate gait impairment (ambulatory with a maximum walking speed of 0.8 m/s, i.e., half of normal speed)
* Able to stand without assistance
* Clinically observable gait asymmetry
* Abnormal co-activation between adductor magnus and rectus femoris (R greater than or equal to 0.5)
Exclusion Criteria
* Visual impairment (such as hemianopia) preventing sufficient perception of the screen to play the games
* Anesthesia or severe neglect in the affected leg, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest) that impairs ability to play the games
* Participation in another study on the affected leg, or any pharmacological study, within 6 weeks of enrollment
* Inability to understand or follow commands in English due to aphasia or other reason that makes it impossible to perform the training
* Diffuse or multifocal infarcts
* Substantial leg or other pain preventing participation for 60 minutes a day
* Spasticity treatment (pharmacological or Botox) on the affected leg within past 3 months
* Contraindication to MRI (metal implants, pacemakers)
* History of epilepsy in adulthood
* Skull abnormalities or fractures near the motor cortex
* Severe osteoporosis causing hip or other fractures
* History of multiple falls within the last year, use of walker for balance, or falling during stance while in the lab in the first session.
* Contracture limiting the range of motion of the leg
* Current pregnancy
* Absence of MEP using TMS (lack of intact corticospinal tract)
18 Years
85 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Texas Southwestern Medical Center
OTHER
Northwestern University
OTHER
Responsible Party
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Marc Slutzky
Professor of Neurology
Principal Investigators
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Marc Slutzky, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU00221627
Identifier Type: -
Identifier Source: org_study_id
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