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Mechanisms of Walking Recovery After Stroke

Not Applicable
Completed
Conditions
Stroke
Interventions
Behavioral: No intervention
Behavioral: High-intensity interval training
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
Arm && Interventions
GroupInterventionDescription
Arm 1High-intensity interval training4-week control period with no intervention and 4-weeks of high-intensity interval training
Arm 1No intervention4-week control period with no intervention and 4-weeks of high-intensity interval training
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

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