MedPath

Mechanisms of Walking Recovery After Stroke

Not Applicable
Completed
Conditions
Stroke
Registration Number
NCT02858349
Lead Sponsor
University of Cincinnati
Brief Summary

Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention.

Detailed Description

Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention using high-intensity interval training.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
Inclusion Criteria
  • age 30-90 years
  • unilateral stroke experienced >6 months prior to enrollment in middle cerebral artery (MCA) territory without complete disruption of the putamen on the lesion side
  • walking speed <= 1.0 m/s on the 10 meter walk test
  • able to walk 10m over ground with assistive devices as needed and no physical assistance
Exclusion Criteria
  • MRI incompatibility (e.g. metallic or electronic implants, severe claustrophobia)
  • inability to perform mental imagery (time dependent motor imagery screening test [TDMI])
  • evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test, or significant baseline ECG abnormalities that would make an exercise ECG uninterpretable
  • recent (<3 months) cardiopulmonary hospitalization
  • unable to communicate with investigators or correctly answer consent comprehension questions
  • significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
  • severe lower extremity (LE) spasticity (Ashworth >2)
  • recent (<3 months) illicit drug or alcohol abuse or significant mental illness
  • major post-stroke depression (PHQ-9 ≥10) in the absence of medical management
  • participating in physical therapy or another interventional research study;
  • recent (<3 months) paretic LE botulinum toxin injection
  • concurrent progressive neurologic disorder or other major medical, orthopedic or peripheral vascular conditions that would limit improvement
  • pregnancy

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Walking SpeedChange from 4-weeks to 8-weeks

10-meter walk test

Secondary Outcome Measures
NameTimeMethod
Gait Symmetrybaseline, 4 weeks, 8 weeks

Paretic step ratio

NIH Toolbox Standing Balance Testbaseline, 4 weeks, 8 weeks
Brain Locomotor Network Activationbaseline, 4 weeks, 8 weeks
Daily Walking Activitybaseline, 4 weeks, 8 weeks

activity monitor

Walking Speedbaseline, 4 weeks, 8 weeks

10-meter walk test

NIH Toolbox - Cognition Domainbaseline, 4 weeks, 8 weeks
Metabolic Cost of Gaitbaseline, 4 weeks, 8 weeks

oxygen consumption rate during comfortable speed gait

Aerobic Capacitybaseline, 4 weeks, 8 weeks

oxygen consumption rate during exercise testing

Brain Locomotor Network Connectivitybaseline, 4 weeks, 8 weeks
Stroke and Aphasia Quality of Life Scalebaseline, 4 weeks, 8 weeks
Walking Capacitybaseline, 4 weeks, 8 weeks

6-minute walk test

Trial Locations

Locations (1)

University of Cincinnati

🇺🇸

Cincinnati, Ohio, United States

University of Cincinnati
🇺🇸Cincinnati, Ohio, United States

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