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OpenTrials
Completed

NCT Number: NCT02858349

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.

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Key information

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Behavioral

No intervention

High-intensity interval training

Behavioral

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

Primary outcomes

  1. Walking Speed

    Time frame: Change from 4-weeks to 8-weeks

    10-meter walk test

Secondary outcomes

  1. Gait Symmetry

    Time frame: baseline, 4 weeks, 8 weeks

    Paretic step ratio

  2. Metabolic Cost of Gait

    Time frame: baseline, 4 weeks, 8 weeks

    oxygen consumption rate during comfortable speed gait

  3. Aerobic Capacity

    Time frame: baseline, 4 weeks, 8 weeks

    oxygen consumption rate during exercise testing

  4. NIH Toolbox - Cognition Domain

    Time frame: baseline, 4 weeks, 8 weeks

  5. NIH Toolbox Standing Balance Test

    Time frame: baseline, 4 weeks, 8 weeks

  6. Stroke and Aphasia Quality of Life Scale

    Time frame: baseline, 4 weeks, 8 weeks

  7. Brain Locomotor Network Activation

    Time frame: baseline, 4 weeks, 8 weeks

  8. Brain Locomotor Network Connectivity

    Time frame: baseline, 4 weeks, 8 weeks

  9. Walking Capacity

    Time frame: baseline, 4 weeks, 8 weeks

    6-minute walk test

  10. Daily Walking Activity

    Time frame: baseline, 4 weeks, 8 weeks

    activity monitor

  11. Walking Speed

    Time frame: baseline, 4 weeks, 8 weeks

    10-meter walk test

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2016
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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