Acute Stroke Clinical Trial
Official title:
The Impact of Gait Training on the Metabolic Costs of Walking and Cardiorespiratory Capacity in Persons Post Stroke
Verified date | October 2018 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This will be a randomized, matched-group study to compare the cardiopulmonary / metabolic
benefits for persons post stroke that learn to walk utilizing early treadmill training
post-acute stroke to persons post stroke that learn to walk utilizing non-treadmill based
gait training during the same time period. Participants (n=30) will be adults who have
completed acute rehabilitation following a stroke. Random assignment will be to either the
ESTT or traditional gait training protocol during the outpatient rehabilitation phase.
1. Group A: Traditional outpatient therapy (n = 15)
2. Group B: Treadmill training (ESTT) outpatient therapy (n = 15)
Status | Completed |
Enrollment | 16 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - confirmed diagnosis of recent cerebrovascular accident (CVA) (less than 6 weeks post at the time of admission to inpatient rehabilitation) - able to give informed consent independently or have family member or other authorized surrogate available to give consent - first time stroke OR complete gait recovery from prior stroke - sufficient support at home to participate in home-based fitness training program - transportation to University of Texas Southwestern Medical Center Gait Disorders Clinic (UTSW GDC) for therapy and testing - ability to follow one-part commands Exclusion Criteria: - non-ambulatory before onset of stroke (at time of admission to inpatient rehabilitation) - bilateral stroke - presence of severe cardiac problems (heart failure [New York Heart Association > Class 2], unstable or exercise-induced angina) - other co-morbidities which could affect gait training (i.e. amputation, spinal cord injury, traumatic brain injury, etc.) - recent myocardial infarct (within 4 weeks of date of inpatient rehabilitation admission) - any uncontrolled health condition for which exercise is contraindicated - severe lower extremity joint disease/pathology that would interfere with gait training - subjects -with body mass index (BMI) greater than 40 - significant cognitive impairment (less than 2 on the Functional Independence Measure [FIM] cognitive sub-scale) - age greater than 80 years or less than 18 years - able to complete 5 or more full heel raises with the affected ankle in standing with the knee extended with no more than one or two fingers on support surface for balance |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern School of Health Professions | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Temporal Spatial Gait Analysis | Testing will be completed using a 14'x4', 16-level pressure sensing Zeno Walkway. This system utilizes a computerized gait system for data collection. Gait parameters that will be collected include center of pressure, center of mass, step/stride length, velocity, toe in/out, cadence, and left/right lower extremity ratios. Participants will be asked to walk at self-selected and safe fast walking paces for repeated straight direction walking trials to collect an average of 100 feet of straight distance. This testing will be done at T1, T2, T3 and T4. This test takes 15 minutes to complete. | At enrollment, week 9, week 17 and week 25. | |
Primary | Maximum Exercise Tolerance Testing | Exercise tests will be performed with a treadmill with a static/dynamic body weight system. Measurements will be conducted with open circuit spirometry. Heart rate will be continuously monitored by electrocardiogram. Blood pressure will be monitored every 2 minutes. Participants will be allowed a 3-minute warm-up. Following the warm-up, participants will be allowed up to 10 minutes to rest or until they recovery to baseline heart rate, respiration rate and blood pressure. | Change in exercise tolerance from enrollment to 9 weeks later and 25 weeks later | |
Primary | Change in 6-Minute Walk Test Distance | Each subject will be asked to complete a 6-Minute Walk test. They will be advised to walk at a pace they think they can maintain for the entire time. Resting is permitted provided they are not required to sit. Participants will not be given any verbal encouragement during the test. A stop watch will be used to time the test and the distance will be measured with a calibrated measuring wheel along a 150 foot corridor. Heart rate will be monitored during the test by means of a Polar chest strap and values will be recorded at each minute of the test. Perceived rate of exertion using the Borg scale of 6-20 will be recorded at rest and each minute of the test.34 Blood pressure using an automated arm cuff will be recorded before and after the test. | At enrollment and week 25. |
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