Mechanisms of Walking Recovery After Stroke

NCT ID: NCT02858349

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

No intervention

Intervention Type: BEHAVIORAL

No intervention

High-intensity interval training

Intervention Type: BEHAVIORAL

High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods

Interventions

No intervention

No intervention

Intervention Type: BEHAVIORAL

High-intensity interval training

High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Pierce Boyne

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pierce Boyne, PT, DPT, NCS

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-1916

Identifier Type: -

Identifier Source: org_study_id