Mechanisms of Walking Recovery After Stroke

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02858349

Enrollment

Registered

2016-08-08

Start date

2016-07-31

Completion date

2017-12-31

Last updated

2019-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

BEHAVIORALNo intervention

No intervention

BEHAVIORALHigh-intensity interval training

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Masking description

Outcomes Assessor was blinded to study design, including when participant was in control phase versus intervention phase

Eligibility

Sex/Gender

ALL

Age

30 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Metabolic Cost of Gait	baseline, 4 weeks, 8 weeks	oxygen consumption rate during comfortable speed gait
Aerobic Capacity	baseline, 4 weeks, 8 weeks	oxygen consumption rate during exercise testing
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	—
Gait Symmetry	baseline, 4 weeks, 8 weeks	Paretic step ratio
Brain Locomotor Network Connectivity	baseline, 4 weeks, 8 weeks	—
Walking Capacity	baseline, 4 weeks, 8 weeks	6-minute walk test
Daily Walking Activity	baseline, 4 weeks, 8 weeks	activity monitor
Walking Speed	baseline, 4 weeks, 8 weeks	10-meter walk test
Brain Locomotor Network Activation	baseline, 4 weeks, 8 weeks	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Arm 1 4-week control period with no intervention and 4-weeks of high-intensity interval training No intervention: No intervention High-intensity interval training: High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods	10
Total	10

Baseline characteristics

Characteristic	Arm 1
Age, Continuous	59.8 years STANDARD_DEVIATION 6.8
Comfortable Gait Speed, m/s	0.41 meters per second STANDARD_DEVIATION 0.33
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	3 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	7 Participants
Region of Enrollment United States	10 participants
Sex: Female, Male Female	4 Participants
Sex: Female, Male Male	6 Participants
Stroke Chronicity	2.4 years STANDARD_DEVIATION 1.7

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 10
other Total, other adverse events	8 / 10
serious Total, serious adverse events	0 / 10

Outcome results

Primary

Walking Speed

10-meter walk test

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Arm 1	Walking Speed	0.13 meters per second

p-value: 0.004295% CI: [0.05, 0.21]Mixed Models Analysis

Secondary