Trial Outcomes & Findings for Metabolic Costs of Walking Post Stroke (NCT NCT02108912)
NCT ID: NCT02108912
Last Updated: 2019-03-01
Results Overview
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.
COMPLETED
NA
16 participants
Change in exercise tolerance from enrollment to 9 weeks later and 25 weeks later
2019-03-01
Participant Flow
Participant milestones
| Measure |
Traditional Outpatient
Traditional outpatient physical therapy
Traditional outpatient: Traditional physical therapy includes standard of care for gait recovery after stroke such as pre-gait activities, standing balance activities, strengthening, walking with assistive devices.
|
ESTT Outpatient
ESTT (early standardized task-specific training) in outpatient rehabilitation
ESTT: ESTT is early-standardized task-specific training is a treadmill and over ground gait protocol for gait recovery after stroke
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Traditional Outpatient
Traditional outpatient physical therapy
Traditional outpatient: Traditional physical therapy includes standard of care for gait recovery after stroke such as pre-gait activities, standing balance activities, strengthening, walking with assistive devices.
|
ESTT Outpatient
ESTT (early standardized task-specific training) in outpatient rehabilitation
ESTT: ESTT is early-standardized task-specific training is a treadmill and over ground gait protocol for gait recovery after stroke
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
lack of transportation
|
1
|
0
|
|
Overall Study
high blood pressure
|
1
|
0
|
Baseline Characteristics
Metabolic Costs of Walking Post Stroke
Baseline characteristics by cohort
| Measure |
Traditional Outpatient
n=9 Participants
Traditional outpatient physical therapy
Traditional outpatient: Traditional physical therapy includes standard of care for gait recovery after stroke such as pre-gait activities, standing balance activities, strengthening, walking with assistive devices.
|
ESTT Outpatient
n=7 Participants
ESTT (early standardized task-specific training) in outpatient rehabilitation
ESTT: ESTT is early-standardized task-specific training is a treadmill and over ground gait protocol for gait recovery after stroke
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Age, Continuous
|
53.7 Years
n=5 Participants
|
53.4 Years
n=7 Participants
|
53.6 Years
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in exercise tolerance from enrollment to 9 weeks later and 25 weeks laterPopulation: The data was corrupted and unable to be analyzed.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At enrollment and week 25.Population: The Borg and blood pressure measures were used to monitor the response of the participants to the activity. If the blood pressure rose too high, for example, testing was terminated. Likewise, if the Borg rating was too high, participants were allowed to rest and vital signs were assessed again.
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.
Outcome measures
| Measure |
Traditional Outpatient
n=6 Participants
Traditional outpatient physical therapy
Traditional outpatient: Traditional physical therapy includes standard of care for gait recovery after stroke such as pre-gait activities, standing balance activities, strengthening, walking with assistive devices.
|
ESTT Outpatient
n=6 Participants
ESTT (early standardized task-specific training) in outpatient rehabilitation
ESTT: ESTT is early-standardized task-specific training is a treadmill and over ground gait protocol for gait recovery after stroke
|
|---|---|---|
|
Change in 6-Minute Walk Test Distance
|
469.3 feet
Interval 128.0 to 661.0
|
529.2 feet
Interval 160.0 to 969.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At enrollment, week 9, week 17 and week 25.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.
Outcome measures
Outcome data not reported
Adverse Events
Traditional Outpatient
ESTT Outpatient
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Karen McCain, PT, DPT, NCS
University of Texas Southwestern Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place