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Mechanisms of Walking Recovery After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No intervention
High-intensity interval training
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Cincinnati

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

4-week control period with no intervention and 4-weeks of high-intensity interval training

Outcomes

Primary Outcome Measures

Walking Speed
10-meter walk test

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2016
Last Updated
November 26, 2018
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT02858349
Brief Title
Mechanisms of Walking Recovery After Stroke
Official Title
Mechanisms of Walking Recovery After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes Assessor was blinded to study design, including when participant was in control phase versus intervention phase
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
4-week control period with no intervention and 4-weeks of high-intensity interval training
Intervention Type
Behavioral
Intervention Name(s)
No intervention
Intervention Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
High-intensity interval training
Intervention Description
High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods
Primary Outcome Measure Information:
Title
Walking Speed
Description
10-meter walk test
Time Frame
Change from 4-weeks to 8-weeks
Secondary Outcome Measure Information:
Title
Gait Symmetry
Description
Paretic step ratio
Time Frame
baseline, 4 weeks, 8 weeks
Title
Metabolic Cost of Gait
Description
oxygen consumption rate during comfortable speed gait
Time Frame
baseline, 4 weeks, 8 weeks
Title
Aerobic Capacity
Description
oxygen consumption rate during exercise testing
Time Frame
baseline, 4 weeks, 8 weeks
Title
NIH Toolbox - Cognition Domain
Time Frame
baseline, 4 weeks, 8 weeks
Title
NIH Toolbox Standing Balance Test
Time Frame
baseline, 4 weeks, 8 weeks
Title
Stroke and Aphasia Quality of Life Scale
Time Frame
baseline, 4 weeks, 8 weeks
Title
Brain Locomotor Network Activation
Time Frame
baseline, 4 weeks, 8 weeks
Title
Brain Locomotor Network Connectivity
Time Frame
baseline, 4 weeks, 8 weeks
Title
Walking Capacity
Description
6-minute walk test
Time Frame
baseline, 4 weeks, 8 weeks
Title
Daily Walking Activity
Description
activity monitor
Time Frame
baseline, 4 weeks, 8 weeks
Title
Walking Speed
Description
10-meter walk test
Time Frame
baseline, 4 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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; 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierce Boyne, PT, DPT, NCS
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mechanisms of Walking Recovery After Stroke

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