Mechanisms of Walking Recovery After Stroke

Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: No intervention; Behavioral: High-intensity interval training

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 4-week control period with no intervention and 4-weeks of high-intensity interval training	Behavioral: No intervention; No intervention; Behavioral: High-intensity interval training; High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking Speed	10-meter walk test	Change from 4-weeks to 8-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Symmetry	Paretic step ratio	baseline, 4 weeks, 8 weeks
Metabolic Cost of Gait	oxygen consumption rate during comfortable speed gait	baseline, 4 weeks, 8 weeks
Aerobic Capacity	oxygen consumption rate during exercise testing	baseline, 4 weeks, 8 weeks
NIH Toolbox - Cognition Domain		baseline, 4 weeks, 8 weeks
NIH Toolbox Standing Balance Test		baseline, 4 weeks, 8 weeks
Stroke and Aphasia Quality of Life Scale		baseline, 4 weeks, 8 weeks
Brain Locomotor Network Activation		baseline, 4 weeks, 8 weeks
Brain Locomotor Network Connectivity		baseline, 4 weeks, 8 weeks
Walking Capacity	6-minute walk test	baseline, 4 weeks, 8 weeks
Daily Walking Activity	activity monitor	baseline, 4 weeks, 8 weeks
Walking Speed	10-meter walk test	baseline, 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Pierce Boyne, PT, DPT, NCS, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2016-1916

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No