NCT02858349CompletedNot Applicable
Mechanisms of Walking Recovery After Stroke
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Cincinnati
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Walking Speed
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcomes Assessor was blinded to study design, including when participant was in control phase versus intervention phase
Eligibility Criteria
- Ages
- 30 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Arm 1
Experimental
4-week control period with no intervention and 4-weeks of high-intensity interval training
Intervention: High-intensity interval training (Behavioral)
Arm 1
Experimental
4-week control period with no intervention and 4-weeks of high-intensity interval training
Intervention: No intervention (Behavioral)
Outcomes
Primary Outcomes
Walking Speed
Time Frame: Change from 4-weeks to 8-weeks
10-meter walk test
Secondary Outcomes
- 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)
- NIH Toolbox - Cognition Domain(baseline, 4 weeks, 8 weeks)
- Metabolic Cost of Gait(baseline, 4 weeks, 8 weeks)
- 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)
Investigators
Pierce Boyne
Assistant Professor
University of Cincinnati
Study Sites (1)
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