Trial Outcomes & Findings for Comparison of Two High-intensity Gait Training Interventions on Contraversive Pushing Behaviors in Individuals Poststroke (NCT NCT04550039)
NCT ID: NCT04550039
Last Updated: 2024-03-01
Results Overview
The Scale for Contraversive Pushing is a three-item test used to measure lateropulsion also known as contraversive pushing behaviors. It is scored on a three point ordinal scale. It rates a participant's action/reaction of maintaining or changing a position in both sitting and standing. A score \>0 in each section indicates the presence of contraversive pushing behaviors. The maximum score is 6. The minimum score is 0, indicating an absence of pushing behaviors. The lower the score, the better.
COMPLETED
NA
14 participants
Baseline, 3 weeks
2024-03-01
Participant Flow
Participant milestones
| Measure |
Body-weight-supported Treadmill Training
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Body-weight-supported treadmill: Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
|
EksoNR Exoskeleton
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Ekso Bionics EksoNR exoskeleton: Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Body-weight-supported Treadmill Training
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Body-weight-supported treadmill: Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
|
EksoNR Exoskeleton
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Ekso Bionics EksoNR exoskeleton: Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
|
|---|---|---|
|
Overall Study
discharge to acute care prior to completion of study
|
2
|
1
|
|
Overall Study
patient self-withdrew from study
|
0
|
1
|
Baseline Characteristics
The data obtained from 3 participants in each group (6 total) was analyzed due to completeness over 3 weeks.
Baseline characteristics by cohort
| Measure |
Body-weight-supported Treadmill Training
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Body-weight-supported treadmill: Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
|
EksoNR Exoskeleton
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Ekso Bionics EksoNR exoskeleton: Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=3 Participants • The data obtained from 3 participants in each group (6 total) was analyzed due to completeness over 3 weeks.
|
62 years
n=3 Participants • The data obtained from 3 participants in each group (6 total) was analyzed due to completeness over 3 weeks.
|
65 years
n=6 Participants • The data obtained from 3 participants in each group (6 total) was analyzed due to completeness over 3 weeks.
|
|
Sex: Female, Male
Female
|
3 Participants
n=3 Participants • The data from 3 participants in each group was analyzed due to completeness (6 total)
|
1 Participants
n=3 Participants • The data from 3 participants in each group was analyzed due to completeness (6 total)
|
4 Participants
n=6 Participants • The data from 3 participants in each group was analyzed due to completeness (6 total)
|
|
Sex: Female, Male
Male
|
0 Participants
n=3 Participants • The data from 3 participants in each group was analyzed due to completeness (6 total)
|
2 Participants
n=3 Participants • The data from 3 participants in each group was analyzed due to completeness (6 total)
|
2 Participants
n=6 Participants • The data from 3 participants in each group was analyzed due to completeness (6 total)
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline, 3 weeksPopulation: Outcome performance data was collected at baseline and at 3 weeks. Average score for each group was calculated at week 0 and week 3. The change scores from baseline to week 3 are used for this analysis. They were calculating by subtracting the average score at baseline from the average score at week 3. Due to noticeable differences in outcome performance for both groups at baseline, percent change was used to provide a more accurate comparison of changes.
The Scale for Contraversive Pushing is a three-item test used to measure lateropulsion also known as contraversive pushing behaviors. It is scored on a three point ordinal scale. It rates a participant's action/reaction of maintaining or changing a position in both sitting and standing. A score \>0 in each section indicates the presence of contraversive pushing behaviors. The maximum score is 6. The minimum score is 0, indicating an absence of pushing behaviors. The lower the score, the better.
Outcome measures
| Measure |
Body-weight-supported Treadmill Training
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Body-weight-supported treadmill: Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
|
EksoNR Exoskeleton
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Ekso Bionics EksoNR exoskeleton: Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
|
|---|---|---|
|
Change in Scale for Contraversive Pushing
|
-47.01 percent change in points
Standard Deviation 47.65
|
-59.72 percent change in points
Standard Deviation 8.67
|
PRIMARY outcome
Timeframe: Baseline, 3 weeksPopulation: Outcome performance data was collected at baseline and at 3 weeks. Average score for each group was calculated at baseline and week 3. The change scores from baseline to week 3 are used for this analysis. They were calculated by subtracting the average score at baseline from the average score at week 3. Due to noticeable differences in outcome performance for both groups at baseline, percent change was used to provide a more accurate comparison of changes.
The Burke Lateropulsion Scale is a five-item test used to measure lateropulsion, scored on a four to five point ordinal scale. It rates a participant's action/reaction of keeping or changing a position in sitting, standing, rolling in supine, transfers, and walking. A lower score is better. The minimum score is 0, indicating the absence of contraversive pushing behaviors. The maximum score is 17. Research indicates a score of ≥2 as a cutoff for the presence of contraversive pushing behaviors.
Outcome measures
| Measure |
Body-weight-supported Treadmill Training
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Body-weight-supported treadmill: Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
|
EksoNR Exoskeleton
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Ekso Bionics EksoNR exoskeleton: Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
|
|---|---|---|
|
Change in Burke Lateropulsion Scale
|
-67.5 percent change in points
Standard Deviation 30.31
|
-53.99 percent change in points
Standard Deviation 29.48
|
SECONDARY outcome
Timeframe: Baseline, 3 weeksPopulation: Outcome performance data was collected at baseline and at 3 weeks. Average score for each group was calculated at baseline and week 3. The change scores from baseline to week 3 are used for this analysis. They were calculated by subtracting the average score at baseline from the average score at week 3. Due to noticeable differences in outcome performance for both groups at baseline, percent change was used to provide a more accurate comparison of changes.
The 10 Meter Walk Test is a common clinical measure of gait speed. Participants are directed to walk at their comfortable, self-selected speed. Participants are positioned at the start line and instructed to walk the entire 10 meter distance while the therapist times the middle six meters. The two meter distance before and after the timed course is meant to minimize the effect of acceleration and deceleration. Time is recorded to the one hundredth of a second (example: 2.46 seconds). The test is performed two times at self-selected speed. The average of the two times is used to calculate velocity in m/s. The minimum gait speed is zero meters/second meaning the participant is unable to ambulate without someone else dependently advancing his/her limb or 2 or more people are required to assist with ambulation. There is no set maximum score. A higher score in meters/second means the participant can ambulate at a faster velocity or gait speed, which is better.
Outcome measures
| Measure |
Body-weight-supported Treadmill Training
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Body-weight-supported treadmill: Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
|
EksoNR Exoskeleton
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Ekso Bionics EksoNR exoskeleton: Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
|
|---|---|---|
|
Change in 10 Meter Walk Test
|
143.33 percent change of velocity
Standard Deviation 176.16
|
220.37 percent change of velocity
Standard Deviation 37.82
|
SECONDARY outcome
Timeframe: Baseline, 3 weeksPopulation: Outcome performance data was collected at baseline and at 3 weeks. Average score for each group was calculated at baseline and week 3. The change scores from baseline to week 3 are used for this analysis. They were calculated by subtracting the average score at baseline from the average score at week 3. Due to noticeable differences in outcome performance for both groups at baseline, percent change was used to provide a more accurate comparison of changes.
The 6 Minute Walk Test measures the distance a participant can walk indoors on a flat, hard surface in a period of six minutes. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test is self-paced. Participants are allowed to stop and rest during the test; however, the timer does not stop. If a participant is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. Appropriate assistive devices, bracing, and the minimal amount of physical assistance from the physical therapist will be applied. Minimum score is zero meters, meaning the participant is unable to ambulate in any given time. There is no set maximum score as the participant is instructed to ambulate the longest distance possible in six minutes. This test is typically measured in meters or feet. A higher value indicates the participant walked a further distance, which is better.
Outcome measures
| Measure |
Body-weight-supported Treadmill Training
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Body-weight-supported treadmill: Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
|
EksoNR Exoskeleton
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Ekso Bionics EksoNR exoskeleton: Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
|
|---|---|---|
|
Change in 6 Minute Walk Test
|
267.65 percent change in meters walked
Standard Deviation 214.33
|
261.42 percent change in meters walked
Standard Deviation 118.97
|
SECONDARY outcome
Timeframe: Baseline, 3 weeksPopulation: Outcome performance data was collected at baseline and at 3 weeks. Average score for each group was calculated at baseline and week 3. The change scores from baseline to week 3 are used for this analysis. They were calculated by subtracting the average score at baseline from the average score at week 3. Due to noticeable differences in outcome performance for both groups at baseline, percent change was used to provide a more accurate comparison of changes.
The Berg Balance Scale is a 14-item test, scored on a five point ordinal scale. It measures functional balance in a clinical setting and includes static and dynamic tasks (such as sitting, standing, transitioning from sitting to standing, standing on one foot, retrieving an object from the floor), during which participants must maintain their balance. The minimum score is 0 and the maximum score is 56. A higher score is better.
Outcome measures
| Measure |
Body-weight-supported Treadmill Training
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Body-weight-supported treadmill: Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
|
EksoNR Exoskeleton
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Ekso Bionics EksoNR exoskeleton: Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
|
|---|---|---|
|
Change in Berg Balance Scale
|
73.33 percent change in points
Standard Deviation 88.08
|
371.67 percent change in points
Standard Deviation 286.20
|
SECONDARY outcome
Timeframe: Baseline, 3 weeksPopulation: Outcome performance data was collected at baseline and at 3 weeks. Average score for each group was calculated at baseline and week 3. The change scores from baseline to week 3 are used for this analysis. They were calculated by subtracting the average score at baseline from the average score at week 3. Due to noticeable differences in outcome performance for both groups at baseline, percent change was used to provide a more accurate comparison of changes.
The Function in Sitting Test is a 14-item test of sitting balance, scored on a five point ordinal scale. It measures sensory, motor, proactive, reactive, and steady state balance factors. The minimum score is 0 and the maximum score is 56. A higher score is better.
Outcome measures
| Measure |
Body-weight-supported Treadmill Training
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Body-weight-supported treadmill: Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
|
EksoNR Exoskeleton
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Ekso Bionics EksoNR exoskeleton: Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
|
|---|---|---|
|
Change in Function in Sitting Test
|
70.57 Percent change in points
Standard Deviation 58.68
|
58.15 Percent change in points
Standard Deviation 34.78
|
SECONDARY outcome
Timeframe: Baseline, 3 weeksPopulation: Data was not collected for this outcome per co-investigators' decision.
The Functional Independence Measure is an 18-item test (13 motor tasks, 5 cognitive tasks) for evaluating level of disability and how much assistance is needed for a participant to perform certain activities of daily living. Each item is scored on a seven point ordinal scale, ranging from 1point, indicating total assistance, to 7 points, indicating total independence. A higher score is better. Items include eating, grooming, bathing, dressing, toileting, bladder/bowel management, transfers, locomotion, stairs, comprehension, expression, social interaction, problem solving, and memory.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 weeks.Population: Data was not collected for this outcome per co-investigators' decision.
This is a standardized, evidence-based measure of health care quality used to track clinical performance and outcomes in post-acute care. Items are scored on a six point ordinal scale, ranging from 6-independent to 1-dependent. A higher sore is better. Items can also be coded as participant refuses, not applicable, environmental limitations, not attempted due to medical condition or safety concerns, or unplanned discharge.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 weeksPopulation: This outcome measure was not collected or analyzed per investigator discretion.
Manual Muscle Test is a procedure for evaluating the strength of 16 individual muscles relative to gravity and manual resistance. Instructions are provided to the participant before testing each muscle. A muscle is isolated, and gradual external force is applied at a right angle to the muscle's long axis. Each muscle is scored on a graded scale of "weak" to "strong" based on the participant's ability to resist the external force. The test is first completed for muscles on the unimpaired side to determine normal strength before being repeated on the impaired side. Weaker participants may be tested while lying prone (gravity eliminated). 0 is a minimum score and 5 is the maximum score. A higher score is better.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 weeks.Population: Data was not collected analyzed for this outcome per co-investigators' decision. This is not typical standard of care at this inpatient of setting,
The purpose of this test is to evaluate a participant's passive range of motion in the joints of the hips, knees, and ankles. The minimum value being 0 degrees and the maximum value varies based on joint. Normative values are different based on joint. Typically, a higher value is better.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 weeksPopulation: Data was not collected analyzed for this outcome per co-investigators' decision. This is not typical standard of care at this inpatient of setting,
The Modified Ashworth Scale is a 6-point ordinal scale used to grade the amount of hypertonicity in individuals with neurological diagnoses. one is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. A score of 0 (minimum) on the scale indicates no increase in tone while a score of 4 (maximum) indicates rigidity. A lower score is better.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3Population: During training, the number of steps were collected for each of the three training sessions per week, over 3 weeks. The median and interquartile ranges across participants in each group was calculated for week 1, week 2 and week 3 using raw values, due to the data not being normally distributed. These values were compared between groups.
The number of steps taken during each training session will be measured using ActiGraph GT9X Link activity monitors. These devices are small accelerometers that can be worn on a belt and/or on the ankle to record steps during an activity. The therapist leading the intervention session will apply the ActiGraph at the beginning of each intervention session and remove it upon completion. The minimum number of steps is 0 and there is no maximum. A higher number of steps in considered better.
Outcome measures
| Measure |
Body-weight-supported Treadmill Training
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Body-weight-supported treadmill: Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
|
EksoNR Exoskeleton
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Ekso Bionics EksoNR exoskeleton: Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
|
|---|---|---|
|
Median Steps Per Session
Week 1 Steps
|
1449 Steps Per session
Interval 735.0 to 1583.0
|
649 Steps Per session
Interval 473.0 to 708.0
|
|
Median Steps Per Session
Week 2 Steps
|
1513 Steps Per session
Interval 1353.0 to 2123.0
|
727 Steps Per session
Interval 725.0 to 891.0
|
|
Median Steps Per Session
Week 3 Steps
|
1505 Steps Per session
Interval 775.0 to 2081.0
|
1091 Steps Per session
Interval 1074.0 to 1097.0
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3Population: During training, maximum heart rate achieved was collected for participants in each of the three training sessions per week, over 3 weeks. The median and interquartile ranges for week 1, week 2 and week 3 in each group were calculated using raw values, due to the data not being normally distributed. These values were compared between groups.
The target range of 70-85% of age-predicted maximum heart rate will be calculated for each participant utilizing HRmax = 208 - \[0.7 × age\] as developed by Tanaka et al in 2001. It is recommended that clinicians should apply moderate to high-intensity walking training to improve walking speed and endurance individuals poststroke. We will record the maximum heart rate, in beats per minute, achieved for participants each gait training session utilizing the Polar OH1 Optical Heart Rate Sensor. There is no maximum or minimum value for this measure. Typically, higher is better.
Outcome measures
| Measure |
Body-weight-supported Treadmill Training
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Body-weight-supported treadmill: Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
|
EksoNR Exoskeleton
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Ekso Bionics EksoNR exoskeleton: Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
|
|---|---|---|
|
Maximum Heart Rate
Week 1 Maximum Heart Rate
|
104 Beats per minute
Interval 101.0 to 120.0
|
119 Beats per minute
Interval 101.0 to 135.0
|
|
Maximum Heart Rate
Week 2 Maximum Heart Rate
|
118 Beats per minute
Interval 93.0 to 119.0
|
124 Beats per minute
Interval 109.0 to 132.0
|
|
Maximum Heart Rate
Week 3 Maximum Heart rate
|
118 Beats per minute
Interval 95.0 to 130.0
|
124 Beats per minute
Interval 112.0 to 136.0
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3Population: Maximum rate of perceived exertion (RPE) achieved was collected for participants in each of the three training sessions per week, over 3 weeks. The median and interquartile ranges for week 1, week 2 and week 3 in each group were calculated using raw values, due to the data not being normally distributed. These values were compared between groups.
The Borg Rating of Perceived Exertion (RPE) is a tool to measure the subjective report of effort, exertion, and fatigue during physical work. It consists of a 15-point scale from 6-20, in which 6=no exertion and 20=absolute maximum exertion. A higher is correlated with higher intensity. It is presented to the participant in written format with descriptors to standardize the report of perceived exertion across tasks.
Outcome measures
| Measure |
Body-weight-supported Treadmill Training
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Body-weight-supported treadmill: Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
|
EksoNR Exoskeleton
n=3 Participants
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Ekso Bionics EksoNR exoskeleton: Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
|
|---|---|---|
|
Maximum Borg Rating of Perceived Exertion
Week 1 Maximum RPE
|
15 Score on a scale
Interval 14.0 to 15.0
|
14 Score on a scale
Interval 13.0 to 15.0
|
|
Maximum Borg Rating of Perceived Exertion
Week 2 Maximum RPE
|
15 Score on a scale
Interval 15.0 to 16.0
|
16 Score on a scale
Interval 15.0 to 16.0
|
|
Maximum Borg Rating of Perceived Exertion
Week 3 Maximum RPE
|
15 Score on a scale
Interval 14.0 to 17.0
|
14 Score on a scale
Interval 14.0 to 17.0
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3Population: Numeric Pain rating scale was not collected for participants per co-investigator discretion.
The Numerical Rating Pain Scale is used to measure the subjective report of pain intensity. It consists of an 11-point scale, 0-10, in which zero indicates no pain and ten indicates the most intense pain imaginable. A lower sore is better.
Outcome measures
Outcome data not reported
Adverse Events
Body-weight-supported Treadmill Training
EksoNR Exoskeleton
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Katherine Enzler, Physical Therapist
Shirley Ryan AbilityLab
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place