MINT Conditioning to Improve Gait

NCT ID: NCT07041775

Last Updated: 2025-06-27

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2030-03-31

Brief Summary

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

Detailed Description

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Conditions

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Stroke Stroke Gait Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MINT group

MINT training of two leg muscles

Group Type EXPERIMENTAL

myoelectric interface for neurorehabilitation (MINT) conditioning

Intervention Type OTHER

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

Sham group

one muscle feedback

Group Type SHAM_COMPARATOR

One muscle myoelectric feedback

Intervention Type OTHER

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.

Intervention Type OTHER

One muscle myoelectric feedback

Training to control muscle activity in one muscle only.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Marc Slutzky

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Marc Slutzky, MD, PhD

Role: CONTACT

312-503-4653

Cynthia Gorski

Role: CONTACT

312-503-6097

Facility Contacts

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Study Principal Investigator

Role: primary

312-503-4653

Yasin Dhaher, PhD

Role: primary

847-331-0793

Other Identifiers

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R01HD113270

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00221627

Identifier Type: -

Identifier Source: org_study_id

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