An interventional study of Body-weight-supported treadmill and Ekso Bionics EksoNR exoskeleton in Stroke, sponsored by Shirley Ryan AbilityLab. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the effect of two high-intensity gait training interventions on contraversive pushing behaviors in individuals poststroke in the acute inpatient rehabilitation setting. We will also evaluate the effect of these interventions on functional mobility, strength, balance, and endurance. Furthermore, we intend to measure therapist burden when mobilizing individuals with contraversive pushing behaviors.
High-intensity gait training is strongly supported in individuals poststroke to facilitate neuroplastic changes in the brain in order to maximize the recovery of functional independence. Individuals with contraversive pushing behaviors (CPB) poststroke are difficult to mobilize as a result of tilted posture with significant balance impairments, a tendency to push toward their hemiparetic side, and resistance to external correction. CPB has been reported in 12-18% of individuals receiving stroke rehabilitation and often leads to longer lengths of stay, poorer functional outcomes, and institutionalized discharge locations compared to individuals poststroke without CPB.
High quality evidence guiding physical therapy intervention, specifically gait training, in individuals with CPB is scarce. Traditional therapeutic interventions in individuals with CPB consists of progressing functional mobility while orienting to midline with various forms of visual and tactile feedback. To further guide best practice in this population, we plan to investigate the effect of two high-intensity gait training interventions on CPB in 10 individuals poststroke in the acute inpatient rehabilitation setting over the course of one year.
Individuals from the inpatient stroke unit at the Shirley Ryan AbilityLab will be recruited and placed into one of two intervention groups. Intervention for group one will consist of body-weight-supported treadmill training + overground gait training. Intervention for group two will consist of gait training in the EksoNR exoskeleton + overground gait training. The commercially available EksoNR is approved by the FDA for use in individuals with stroke diagnoses. We will also evaluate the effect of these interventions on functional outcomes including mobility, strength, balance, walking speed, and walking endurance in addition to measuring therapist burden when mobilizing individuals with CPB.
Both groups will receive their specified gait training intervention three sessions a week for at least three weeks until they discharge with the goal of maximizing the number of steps within a 60 minute session. Gait training interventions will be progressed to challenge individuals as appropriate in order to reach 70-85% of age-predicted maximum heart rate. A fourth session will be utilized to assess weekly outcome measures as part of the standard of care at the Shirley Ryan AbilityLab. There will be no restrictions set on therapy delivered outside of these intervention training sessions as individuals will be getting other therapies each day as the standard of care.
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Exclusion Criteria:
EksoNR Exclusion Criteria:
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Device: Body-weight-supported treadmill
Participants complete prescribed gait training program for at least three weeks or until they discharge.
Device: Ekso Bionics EksoNR exoskeleton
Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
Change in Scale for Contraversive Pushing
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.
Time frame: Baseline, 3 weeks
Change in Burke Lateropulsion Scale
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.
Time frame: Baseline, 3 weeks
Change in 10 Meter Walk Test
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.
Time frame: Baseline, 3 weeks
Change in 6 Minute Walk Test
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.
Time frame: Baseline, 3 weeks
Change in Berg Balance Scale
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.
Time frame: Baseline, 3 weeks
Change in Function in Sitting Test
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.
Time frame: Baseline, 3 weeks
Change in Functional Independence Measure
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.
Time frame: Baseline, 3 weeks
Change in Quality Indicators
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.
Time frame: Baseline, 3 weeks.
Change in Manual Muscle Test
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.
Time frame: Baseline, 3 weeks
Change in Passive Range of Motion
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.
Time frame: Baseline, 3 weeks.
Change in Modified Ashworth Scale
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.
Time frame: Baseline, 3 weeks
Median Steps Per Session
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.
Time frame: Week 1, Week 2, Week 3
Maximum Heart Rate
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.
Time frame: Week 1, Week 2, Week 3
Maximum Borg Rating of Perceived Exertion
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.
Time frame: Week 1, Week 2, Week 3
Numerical Rating Pain Scale
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.
Time frame: Week 1, Week 2, Week 3
| Milestone | Body-weight-supported Treadmill Training | EksoNR Exoskeleton |
|---|---|---|
| Started | 7 | 7 |
| Completed | 5 | 5 |
| Not completed | 2 | 2 |
| Withdrew: Discharge to acute care prior to completion of study | 2 | 1 |
| Withdrew: Patient self-withdrew from study | 0 | 1 |
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.
| percent change in points | Body-weight-supported Treadmill Training | EksoNR Exoskeleton |
|---|---|---|
| Change in Scale for Contraversive Pushing | -47.01 ± 47.65 | -59.72 ± 8.67 |
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.
| percent change in points | Body-weight-supported Treadmill Training | EksoNR Exoskeleton |
|---|---|---|
| Change in Burke Lateropulsion Scale | -67.5 ± 30.31 | -53.99 ± 29.48 |
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.
| percent change of velocity | Body-weight-supported Treadmill Training | EksoNR Exoskeleton |
|---|---|---|
| Change in 10 Meter Walk Test | 143.33 ± 176.16 | 220.37 ± 37.82 |
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.
| percent change in meters walked | Body-weight-supported Treadmill Training | EksoNR Exoskeleton |
|---|---|---|
| Change in 6 Minute Walk Test | 267.65 ± 214.33 | 261.42 ± 118.97 |
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.
| percent change in points | Body-weight-supported Treadmill Training | EksoNR Exoskeleton |
|---|---|---|
| Change in Berg Balance Scale | 73.33 ± 88.08 | 371.67 ± 286.20 |
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.
| Percent change in points | Body-weight-supported Treadmill Training | EksoNR Exoskeleton |
|---|---|---|
| Change in Function in Sitting Test | 70.57 ± 58.68 | 58.15 ± 34.78 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| Steps Per session | Body-weight-supported Treadmill Training | EksoNR Exoskeleton |
|---|---|---|
| Week 1 Steps | 1449 (735 to 1583) | 649 (473 to 708) |
| Week 2 Steps | 1513 (1353 to 2123) | 727 (725 to 891) |
| Week 3 Steps | 1505 (775 to 2081) | 1091 (1074 to 1097) |
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.
| Beats per minute | Body-weight-supported Treadmill Training | EksoNR Exoskeleton |
|---|---|---|
| Week 1 Maximum Heart Rate | 104 (101 to 120) | 119 (101 to 135) |
| Week 2 Maximum Heart Rate | 118 (93 to 119) | 124 (109 to 132) |
| Week 3 Maximum Heart rate | 118 (95 to 130) | 124 (112 to 136) |
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.
| Score on a scale | Body-weight-supported Treadmill Training | EksoNR Exoskeleton |
|---|---|---|
| Week 1 Maximum RPE | 15 (14 to 15) | 14 (13 to 15) |
| Week 2 Maximum RPE | 15 (15 to 16) | 16 (15 to 16) |
| Week 3 Maximum RPE | 15 (14 to 17) | 14 (14 to 17) |
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.
No measurements were reported for this outcome.
Collected over Adverse event data was collected over a 1 year period, throughout the completion of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Body-weight-supported Treadmill Training | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| EksoNR Exoskeleton | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Continuous(years) | Body-weight-supported Treadmill Training | EksoNR Exoskeleton | Total |
|---|---|---|---|
| Median | 68 (44 to 72) | 62 (53 to 72) | 65 (50.75 to 72) |
| Sex: Female, Male(Participants) | Body-weight-supported Treadmill Training | EksoNR Exoskeleton | Total |
|---|---|---|---|
| Female | 3 | 1 | 4 |
| Male | 0 | 2 | 2 |
| Race and Ethnicity Not Collected(Participants) | Body-weight-supported Treadmill Training | EksoNR Exoskeleton | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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