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Recruiting NCT07041775

MINT Conditioning to Improve Gait

No phase Interventional Stroke Stroke Gait Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: myoelectric interface for neurorehabilitation (MINT) conditioning, One muscle myoelectric feedback.
Who it may be relevant to
Registry conditions: Stroke, Stroke Gait Rehabilitation. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

MINT Conditioning to Improve Post-stroke Gait

Overview

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

Interventions

  • Other 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.
  • Other One muscle myoelectric feedback
    Training to control muscle activity in one muscle only.

Primary outcome measures

  • 10-m walk test [Time frame: Baseline and 4 weeks]
Secondary outcome measures (5)
  • 6-min walk test [Time frame: Baseline and week 4]
  • 10-m walk test [Time frame: Baseline and week 8]
  • 6-min walk test [Time frame: Baseline and week 8]
  • MINT performance [Time frame: each training session]
  • Target muscle co-activation [Time frame: Baseline and weeks 4 and 8]

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
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Northwestern University — Chicago
  • University of Texas Southwestern Medical Center — Dallas

Identifiers

NCT: NCT07041775 · STU00221627 · R01HD113270

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗