NCT02858349
Completed
N/A
Mechanisms of Walking Recovery After Stroke
ConditionsStroke
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Cincinnati
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Walking Speed
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Pierce Boyne
Assistant Professor
University of Cincinnati
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Walking Speed
Time Frame: Change from 4-weeks to 8-weeks
10-meter walk test
Secondary Outcomes
- Gait Symmetry(baseline, 4 weeks, 8 weeks)
- NIH Toolbox Standing Balance Test(baseline, 4 weeks, 8 weeks)
- Brain Locomotor Network Activation(baseline, 4 weeks, 8 weeks)
- Daily Walking Activity(baseline, 4 weeks, 8 weeks)
- Walking Speed(baseline, 4 weeks, 8 weeks)
- NIH Toolbox - Cognition Domain(baseline, 4 weeks, 8 weeks)
- Metabolic Cost of Gait(baseline, 4 weeks, 8 weeks)
- Aerobic Capacity(baseline, 4 weeks, 8 weeks)
- Brain Locomotor Network Connectivity(baseline, 4 weeks, 8 weeks)
- Stroke and Aphasia Quality of Life Scale(baseline, 4 weeks, 8 weeks)
- Walking Capacity(baseline, 4 weeks, 8 weeks)
Study Sites (1)
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