MINT Conditioning to Improve Gait

Not Applicable

Not yet recruiting

• Conditions: Stroke; Stroke Gait Rehabilitation

• Registration Number: NCT07041775
• Lead Sponsor: Northwestern University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-19
• Last Update Submitted: 2025-06-19
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-09-01
• Primary Completion: 2030-01
• Study Completion: 2030-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
10-m walk test	Baseline and 4 weeks	The 10-m walk test measures gait speed

Secondary Outcome Measures

Name	Time	Method
6-min walk test	Baseline and week 8	The 6-min walk test measures the distance subjects can walk in 6 min. It measures endurance.
10-m walk test	Baseline and week 8	The 10-m walk test measures gait speed
MINT performance	each training session	The mean weighted time-to-target over trials.
Target muscle co-activation	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.

Trial Locations

Locations (2)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States