Mechanisms of Walking Recovery After Stroke
- Conditions
- Stroke
- Interventions
- Behavioral: No interventionBehavioral: 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
- 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
- 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
Group Intervention Description Arm 1 High-intensity interval training 4-week control period with no intervention and 4-weeks of high-intensity interval training Arm 1 No intervention 4-week control period with no intervention and 4-weeks of high-intensity interval training
- Primary Outcome Measures
Name Time Method Walking Speed Change from 4-weeks to 8-weeks 10-meter walk test
- Secondary Outcome Measures
Name Time Method Gait Symmetry baseline, 4 weeks, 8 weeks Paretic step ratio
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 activity monitor
Walking Speed baseline, 4 weeks, 8 weeks 10-meter walk test
NIH Toolbox - Cognition Domain baseline, 4 weeks, 8 weeks Metabolic Cost of Gait baseline, 4 weeks, 8 weeks oxygen consumption rate during comfortable speed gait
Aerobic Capacity baseline, 4 weeks, 8 weeks oxygen consumption rate during exercise testing
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 6-minute walk test
Trial Locations
- Locations (1)
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States