MINT Conditioning to Improve Gait

NCT07041775 | Not Yet Recruiting DMC

• 2 other identifiers: STU00221627R01HD113270
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Stroke; Stroke Gait Rehabilitation

Keywords

Stroke rehabilitation; Leg impairment; Walking; Rehabilitation gaming; Muscle biofeedback; Myoelectric interface

Outcome Measures

Primary Outcomes (1)

• 10-m walk test

  The 10-m walk test measures gait speed

  Baseline and 4 weeks

Secondary Outcomes (5)

• 6-min walk test

  Baseline and week 4

• 10-m walk test

  Baseline and week 8

• 6-min walk test

  Baseline and week 8

• MINT performance

  each training session

• Target muscle co-activation

  Baseline and weeks 4 and 8

Study Arms (2)

MINT group

EXPERIMENTAL

MINT training of two leg muscles

Other: myoelectric interface for neurorehabilitation (MINT) conditioning

Sham group

SHAM COMPARATOR

one muscle feedback

Other: One muscle myoelectric feedback

Interventions

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.

MINT group

One muscle myoelectric feedback OTHER

Training to control muscle activity in one muscle only.

Sham group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Neurological Rehabilitation; SPEN protein, human

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marc Slutzky, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Slutzky, MD, PhD

CONTACT

312-503-4653; mslutzky@northwestern.edu

Cynthia Gorski

CONTACT

312-503-6097; cynthia.gorski@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 27, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: IPD and associated analytic code will be made available upon publication of research results and will remain available for the duration of the funded project.

Locations

US (2)