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New treatment option for Stroke
Official title MINT Conditioning to Improve Gait
ClinicalTrials.gov ID: NCT07041775
What this study is testing
- What it's testing
- This study will test the ability of myoelectric interface for neurorehabilitation (MINT) training to improve walking function.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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
You likely can't join 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...
- 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
See the full eligibility 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)
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.