Stroke, Stroke Gait Rehabilitation
Conditions
Keywords
Stroke rehabilitation, Leg impairment, Walking, Rehabilitation gaming, Muscle biofeedback, Myoelectric interface
Brief summary
This study will test the ability of myoelectric interface for neurorehabilitation (MINT) training to improve walking function.
Interventions
OTHERmyoelectric interface for neurorehabilitation (MINT) conditioning
Myoelectric interface for neurorehabilitation (MINT) conditioning involves training to reduce abnormal co-activation of limb muscles to improve movement.
OTHEROne muscle myoelectric feedback
Training to control muscle activity in one muscle only.
Sponsors
Northwestern University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10-m walk test | Baseline and 4 weeks | The 10-m walk test measures gait speed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-min walk test | Baseline and week 4 | 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. |
Countries
United States
Contacts
CONTACTMarc Slutzky, MD, PhD
CONTACTCynthia Gorski
PRINCIPAL_INVESTIGATORMarc Slutzky, MD, PhD
Northwestern University
Outcome results
None listed