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Search / Trial NCT07041775

MINT Conditioning to Improve Gait

Launched by NORTHWESTERN UNIVERSITY · Jun 19, 2025

Trial Information

Current as of November 01, 2025

Not yet recruiting

Keywords

Stroke Rehabilitation Leg Impairment Walking Rehabilitation Gaming Muscle Biofeedback Myoelectric Interface

ClinConnect Summary

This clinical trial is studying a new type of training called MINT (myoelectric interface for neurorehabilitation) to help improve walking ability in people who have had a stroke. The goal is to see if this training can help those who have trouble walking, especially if their walking is uneven or slower than usual due to leg weakness on one side of the body.

People who may be able to join the study are adults between 18 and 85 years old who had a stroke at least six months ago and still have moderate to severe difficulty walking. Participants need to be able to stand on their own and show certain patterns of leg muscle movement that affect their walking. Those with serious memory or attention problems, vision issues that make it hard to see the training screen, or other health concerns like recent treatments for muscle stiffness or certain medical devices may not be eligible. During the study, participants will take part in MINT training, which involves using a computer interface that responds to muscle signals to guide walking exercises. This training aims to help improve muscle control and make walking easier and more balanced. The study is not yet enrolling participants but is designed to provide new options for stroke survivors working to regain their walking skills.

Gender

ALL

Eligibility criteria

  • 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
  • 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)

About Northwestern University

Northwestern University is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a robust infrastructure that supports interdisciplinary collaboration, Northwestern leverages its expertise in various fields, including medicine, engineering, and social sciences, to drive groundbreaking studies. The university is dedicated to adhering to the highest ethical standards and regulatory compliance, ensuring that all clinical trials are conducted with the utmost integrity and focus on participant safety. Through its Clinical Trials Office, Northwestern aims to translate scientific discoveries into effective therapies, ultimately enhancing health outcomes and contributing to the broader medical community.

Locations

Chicago, Illinois, United States

Dallas, Texas, United States

Patients applied

0 patients applied

Trial Officials

Marc Slutzky, MD, PhD

Principal Investigator

Northwestern University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported