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NCT Number: NCT07041775

MINT Conditioning to Improve Gait

This study will test the ability of myoelectric interface for neurorehabilitation (MINT) training to improve walking function.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age at enrollment is 18 to 85
  • 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

  • Cognitive impairment with at least moderately impaired attention on digit-span test, or unable to follow instructions of the MINT task
  • 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
  • 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
  • From the TMS portion of the study only: History of epilepsy in adulthood requiring antiseizure medications; recent/current alcoholism or benzodiazepine/barbiturate abuse or recent history of alcohol/benzodiazepine/barbiturate withdrawal, recent history of cocaine or amphetamine use, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, vagus nerve stimulator, cochlear implant, deep brain stimulator, intracranial/carotid stents, cardiac pacemaker/AICD.

Treatment and study plan

myoelectric interface for neurorehabilitation (MINT) conditioning

Other

Myoelectric interface for neurorehabilitation (MINT) conditioning involves training to reduce abnormal co-activation of limb muscles to improve movement.

One muscle myoelectric feedback

Other

Training to control muscle activity in one muscle only.

Primary outcomes

  1. 10-m walk test

    Time frame: Baseline and 4 weeks

    The 10-m walk test measures gait speed

Secondary outcomes

  1. 6-min walk test

    Time frame: Baseline and week 4

    The 6-min walk test measures the distance subjects can walk in 6 min. It measures endurance.

  2. 10-m walk test

    Time frame: Baseline and week 8

    The 10-m walk test measures gait speed

  3. 6-min walk test

    Time frame: Baseline and week 8

    The 6-min walk test measures the distance subjects can walk in 6 min. It measures endurance.

  4. MINT performance

    Time frame: each training session

    The mean weighted time-to-target over trials.

  5. Target muscle co-activation

    Time frame: Baseline and weeks 4 and 8

    The co-activation (correlation) between the targeted muscles daily during training and in the lab sessions during the evaluation times.

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Gorski

CONTACT

[email protected]

312-503-6097

Marc Slutzky, MD, PhD

CONTACT

[email protected]

312-503-4653

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Texas Southwestern Medical Center

Registry information

Official study title

MINT Conditioning to Improve Post-stroke Gait

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 27, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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