Clinical trial NCT02858349: Mechanisms of Walking Recovery After Stroke
Official title: Mechanisms of Walking Recovery After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Walking Speed
timeFrame: Change from 4-weeks to 8-weeks
Secondary outcomes:
measure: Gait Symmetry
timeFrame: baseline, 4 weeks, 8 weeks
measure: Metabolic Cost of Gait
timeFrame: baseline, 4 weeks, 8 weeks
measure: Aerobic Capacity
timeFrame: baseline, 4 weeks, 8 weeks
measure: NIH Toolbox - Cognition Domain
timeFrame: baseline, 4 weeks, 8 weeks
measure: NIH Toolbox Standing Balance Test
timeFrame: baseline, 4 weeks, 8 weeks
measure: Stroke and Aphasia Quality of Life Scale
timeFrame: baseline, 4 weeks, 8 weeks
measure: Brain Locomotor Network Activation
timeFrame: baseline, 4 weeks, 8 weeks
measure: Brain Locomotor Network Connectivity
timeFrame: baseline, 4 weeks, 8 weeks
measure: Walking Capacity
timeFrame: baseline, 4 weeks, 8 weeks
measure: Daily Walking Activity
timeFrame: baseline, 4 weeks, 8 weeks
measure: Walking Speed
timeFrame: baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Pierce Boyne, PT, DPT, NCS
role: PRINCIPAL_INVESTIGATOR
References: