StrokeNCT07041775
MINT Conditioning to Improve Gait
A study testing myoelectric interface for neurorehabilitation (MINT) conditioning and One muscle myoelectric feedback in people with Stroke and Stroke Gait Rehabilitation, run by Northwestern University at 2 sites in United States.
Trial summary
This study will test the ability of myoelectric interface for neurorehabilitation (MINT) training to improve walking function. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Stroke Gait Rehabilitation
- What is being tested?
- myoelectric interface for neurorehabilitation (MINT) conditioning and One muscle myoelectric feedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jun 2026to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Study Principal Investigator, 312-503-4653, mslutzky@northwestern.edu
- Not yet recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Yasin Dhaher, PhD, 847-331-0793, yasin.dhaher@utsouthwestern.edu
About this study
Official title: MINT Conditioning to Improve Post-stroke Gait
This study will test the ability of myoelectric interface for neurorehabilitation (MINT) training to improve walking function.
- Conditions
- Stroke, Stroke Gait Rehabilitation
- Being tested
- myoelectric interface for neurorehabilitation (MINT) conditioning, One muscle myoelectric feedback
- Keywords
- Stroke rehabilitation, Leg impairment, Walking, Rehabilitation gaming, Muscle biofeedback, Myoelectric interface
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myoelectric interface for neurorehabilitation (MINT) conditioningOther
Myoelectric interface for neurorehabilitation (MINT) conditioning involves training to reduce abnormal co-activation of limb muscles to improve movement.
One muscle myoelectric feedbackOther
Training to control muscle activity in one muscle only.
| Study group | Role | What they receive |
|---|---|---|
| MINT group | Experimental | MINT training of two leg muscles Receives: Other: myoelectric interface for neurorehabilitation (MINT) conditioning |
| Sham group | Sham comparator | one muscle feedback Receives: Other: One muscle myoelectric feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-m walk test
The 10-m walk test measures gait speed
Measured: Baseline and 4 weeks
Secondary outcomes (5)
6-min walk test
The 6-min walk test measures the distance subjects can walk in 6 min. It measures endurance.
Measured: Baseline and week 4
10-m walk test
The 10-m walk test measures gait speed
Measured: Baseline and week 8
6-min walk test
The 6-min walk test measures the distance subjects can walk in 6 min. It measures endurance.
Measured: Baseline and week 8
MINT performance
The mean weighted time-to-target over trials.
Measured: each training session
Target muscle co-activation
The co-activation (correlation) between the targeted muscles daily during training and in the lab sessions during the evaluation times.
Measured: Baseline and weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start4 Jun 2026
- Primary completionJan 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Texas Southwestern Medical Center
- Responsible party
- Principal investigator, Marc Slutzky, Northwestern University
- Investigators
- Marc Slutzky, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041775
- Sponsor's protocol ID
- STU00221627
- Other IDs
- R01HD113270
- Status last verified
- Jun 2026
- First submitted
- 29 May 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and metadata will be shared in the Data Archive for the BRAIN Initiative (DABI) database. Clinical functional outcomes, gait kinematics, and analyzed EMG (co-activation), will be uploaded and shared upon publication.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINT Conditioning to Improve Post-stroke Gait
- ClinicalTrials.gov ID
- NCT07041775
- Acronym / sponsor ID
- STU00221627
- Conditions
- Stroke, Stroke Gait Rehabilitation
- Keywords
- Stroke rehabilitation, Leg impairment, Walking, Rehabilitation gaming, Muscle biofeedback, Myoelectric interface
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Texas Southwestern Medical Center
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the ability of myoelectric interface for neurorehabilitation (MINT) training to improve walking function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINT group | Experimental | Other: myoelectric interface for neurorehabilitation (MINT) conditioningMINT training of two leg muscles |
| Sham group | Sham comparator | Other: One muscle myoelectric feedbackone muscle feedback |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myoelectric interface for neurorehabilitation (MINT) conditioningMyoelectric interface for neurorehabilitation (MINT) conditioning involves training to reduce abnormal co-activation of limb muscles to improve movement. | Other | MINT group |
| One muscle myoelectric feedbackTraining to control muscle activity in one muscle only. | Other | Sham group |
Primary outcome
10-m walk test
Time frame: Baseline and 4 weeks
The 10-m walk test measures gait speed
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Yes. Data and metadata will be shared in the Data Archive for the BRAIN Initiative (DABI) database. Clinical functional outcomes, gait kinematics, and analyzed EMG (co-activation), will be uploaded and shared upon publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Slutzky, MD, PhD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myoelectric interface for neurorehabilitation (MINT) conditioning and One muscle myoelectric feedback in people with Stroke and Stroke Gait Rehabilitation, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Slutzky, MD, PhD (312-503-4653, mslutzky@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-m walk test (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.