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Clinical Trials/NCT02858349
NCT02858349
Completed
N/A

Mechanisms of Walking Recovery After Stroke

University of Cincinnati1 site in 1 country10 target enrollmentJuly 2016
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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
December 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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