MINT Conditioning to Improve Gait

Northwestern University

Status: Not yet enrolling

Conditions: Stroke; Stroke Gait Rehabilitation

Treatments: Other: myoelectric interface for neurorehabilitation (MINT) conditioning; Other: One muscle myoelectric feedback

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07041775

R01HD113270 (U.S. NIH Grant/Contract)

STU00221627

Details and patient eligibility

About

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

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

MINT group

Experimental group

Description:

MINT training of two leg muscles

Treatment:

Other: myoelectric interface for neurorehabilitation (MINT) conditioning

Sham group

Sham Comparator group

Description:

one muscle feedback

Treatment:

Other: One muscle myoelectric feedback