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Veterans and other Americans who survive stroke often face disabling motor impairments that impede performance of activities of daily living and limit free-living activity. Prominent among these are diminished walking and balance functions, which not only foster a sedentary lifestyle and physical deconditioning, but also increase the risk of injuries due to falls. Recent research has demonstrated how motor learning based interventions can modify brain activity and improve motor functions in persons with stroke. Now there is a major research opportunity to advance the effectiveness of these interventions by applying new robotics technologies to improve control of essential functions such as gait and balance. One critical area for performance of walking and standing balance is the control of the ankles, as they are a major conduit of mechanical power in gait and also modulate torques affecting the motion of the whole body center of mass when balancing. Thus the current proposal is designed to investigate two approaches for using an impedance controlled ankle robot to improve gait and balance among stroke survivors with chronic lower extremity weakness. One approach uses the ankle robot in a seated visuomotor training program that focuses has subjects play video games with the weaker ankle to improve paretic ankle motor control that may carry over to gait and balance functions. The other approach uses task-specific gait training by integrating use of the ankle robot during treadmill exercise training to assess effects on the same functions. The effectiveness of both robotics approaches will be compared to that of a treadmill exercise program without robotics.
Veterans and other Americans who survive stroke often face disabling motor impairments that impede performance of activities of daily living and limit free-living activity. Prominent among these are diminished locomotor function and impaired balance that not only foster a sedentary lifestyle and physical deconditioning, but also increase the risk injuries due to falls. Recent research has demonstrated how motor learning based interventions can modify brain activity and improve motor functions in persons with stroke. Now there is a major research opportunity to advance the effectiveness of these interventions by applying new robotics technologies to improve neuromotor control of essential functions such as gait and balance. One critical area for performance of walking and standing balance is the control of the ankles, as they are a major conduit of mechanical power in gait and also modulate torques affecting the motion of the whole body center of mass when balancing. Thus the current proposal is designed to investigate two approaches for using an impedance controlled ankle robot to improve gait and balance function among stroke survivors with chronic lower extremity hemiparesis. One approach uses the ankle robot in a seated visuomotor training program that focuses on improving paretic ankle motor control that may transfer to gait and balance functions. The other approach follows the dominant rehabilitation paradigm of task-specific training by integrating use of the ankle robot during treadmill exercise training to assess effects on the same outcomes. The effectiveness of both robotics approaches will be compared to that of a treadmill exercise program without robotics.
The study tests the hypothesis that, in persons with chronic lower extremity hemiparesis, 6 weeks of seated ankle robot training will improve paretic ankle motor control with major improvements in standing balance and moderate improvements in gait, whereas the same amount of training on the treadmill with the ankle robot will improve gait function more than balance. Both robot-trained groups will outperform the treadmill only group on balance, while the treadmill + robot group will make the greatest gains in gait and the seated robot group will make some improvement in gait but will show greater gains in ankle motor control and balance.
Aims: In a 6-week intervention (18 sessions) with persons with chronic lower extremity hemiparesis 1) Compare effects of seated visuomotor ankle robot training vs. treadmill + robot training on paretic ankle impairments and motor control; 2) Compare effects of seated-robot vs. treadmill + robot training on functional mobility and balance outcomes; and 3) Compare the effectiveness of both robotics approaches to a standard treadmill exercise protocol of the same duration. This proposal will establish the initial comparative efficacy of two motor learning based approaches using a modular impedance controlled ankle robot and contrast motor control and functional gait and balance outcomes among them. As a pilot study we also will establish initial deficit profiles for users that respond to each intervention across the 6-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. |
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| Arm 2 | Experimental | Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. |
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| Arm 3 | Active Comparator | Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seated Robot Training (SRT) | Behavioral | Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention | Velocity and associated spatio-temporal gait parameters from self-selected most comfortable and fastest floor walking over 10m. | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Kinetics | Anterior-posterior and medio-lateral ground reaction forces during walking to assess propulsive impulses from paretic and nonparetic sides. | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) |
| Berg Balance Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry W Forrester, PhD | VA Maryland Health Care System, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27255156 | Derived | Forrester LW, Roy A, Hafer-Macko C, Krebs HI, Macko RF. Task-specific ankle robotics gait training after stroke: a randomized pilot study. J Neuroeng Rehabil. 2016 Jun 2;13(1):51. doi: 10.1186/s12984-016-0158-1. |
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Seven subjects who were enrolled (via informed consent) did not receive the allocated intervention due to: relocation (3), lack of transportation (2), re-entry into physical therapy (1), and deemed too high functioning upon neurological re-examination (1). These pre-assignment losses were not counted in the subject tally of baseline assessments.
Recruitment from greater Baltimore area was from IRB approved stroke registry and word of mouth
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| ID | Title | Description |
|---|---|---|
| FG000 | Seated Robot Training (SRT) | Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. |
| FG001 | Treadmill Robot Training (TMR) | Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. |
| FG002 | Treadmill Only (TMO) | Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period. Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Groups were compared at baseline using Friedmans test and Wilcoxon Sign Rank tests
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| ID | Title | Description |
|---|---|---|
| BG000 | Seated Robot Training (SRT) | Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention | Velocity and associated spatio-temporal gait parameters from self-selected most comfortable and fastest floor walking over 10m. | Nonparametric Fisher's exact test was applied to compare between group changes at retention. | Posted | Mean | Standard Error | cm/sec | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) |
|
1 year, 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Seated Robot Training (SRT) | Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jacksonian Seizure | Nervous system disorders | Non-systematic Assessment | Subject reported changes in paretic leg function. Immediate screen by study neurologist led to emergency room referral. Subject received complete neuro exam; prescribed antiseizure medication and discharged two days post. Subject completed training. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle soreness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Was more common in early sessions with treadmill + robotics (TMR) as they had more vigorous exercise, resolved in 1-2 days. |
The control group was limited in both numbers and the fact that they were not available for retention testing. The technical challenges for reliable collection of anticipatory postural adjustments meant loss of those data for analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry Forrester, PhD | VA Maryland Health Care System | 410-637-3241 | Larry.Forrester@va.gov |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Treadmill Locomotor-based Training (TMR) | Behavioral | Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. |
|
| Treadmill Only (TMO) | Behavioral | Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period. |
|
14-item scale to assess balance function and fall risk, 56 is top score possible (0-56); higher scores indicate higher balance function. Items assess static and dynamic activities of varying difficulty; they are performed to evaluate global level of balance function. Item-level scores range from 0-4, determined by ability to perform the assessed activity; item scores are summed to create the overall score. Subscales are not analyzed. |
| Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) |
| Dynamic Gait Index | The Dynamic Gait Index (DGI) assesses individual's ability to modify balance while walking in the presence of external demands. Performed with a marked distance of 20 feet . The DGI can be performed with or without an assistive device. Scores are based on a 4-point scale: 3 = No gait dysfunction; 2 = Minimal impairment; 1 = Moderate impairment; 0 = Severe impairment. The highest possible score is 24 points. asks include: Steady state walking; Walking with changing speeds; Walking with head turns both horizontally and vertically; Walking while stepping over and around obstacles; Pivoting while walking; Stair climbing. | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) |
| Anticipatory Postural Adjustments | During gait initiation two force plates measure ground reaction forces and impulses for the postural shifts made in preparation to begin walking. | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) |
| BG001 | Treadmill Robot Training (TMR) | Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. |
| BG002 | Treadmill Only (TMO) | Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period. Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Treadmill Robot Training (TMR) | Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. |
| OG002 | Treadmill Only (TMO) | Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period. Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period. |
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| Secondary | Gait Kinetics | Anterior-posterior and medio-lateral ground reaction forces during walking to assess propulsive impulses from paretic and nonparetic sides. | Nonparametric Fisher's exact test was applied to compare between group changes at retention. | Posted | Mean | Standard Error | Newton-seconds | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) |
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| Secondary | Berg Balance Scale | 14-item scale to assess balance function and fall risk, 56 is top score possible (0-56); higher scores indicate higher balance function. Items assess static and dynamic activities of varying difficulty; they are performed to evaluate global level of balance function. Item-level scores range from 0-4, determined by ability to perform the assessed activity; item scores are summed to create the overall score. Subscales are not analyzed. | Nonparametric Fisher's exact test was applied to compare between group changes at retention. | Posted | Mean | Standard Error | units on a scale | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) |
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| Secondary | Dynamic Gait Index | The Dynamic Gait Index (DGI) assesses individual's ability to modify balance while walking in the presence of external demands. Performed with a marked distance of 20 feet . The DGI can be performed with or without an assistive device. Scores are based on a 4-point scale: 3 = No gait dysfunction; 2 = Minimal impairment; 1 = Moderate impairment; 0 = Severe impairment. The highest possible score is 24 points. asks include: Steady state walking; Walking with changing speeds; Walking with head turns both horizontally and vertically; Walking while stepping over and around obstacles; Pivoting while walking; Stair climbing. | Nonparametric Fisher's exact test was applied to compare between group changes at retention. | Posted | Mean | Standard Error | units on a scale | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) |
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| Secondary | Anticipatory Postural Adjustments | During gait initiation two force plates measure ground reaction forces and impulses for the postural shifts made in preparation to begin walking. | These data were not collected due to technical issues. | Posted | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) |
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| 2 |
| 14 |
| 3 |
| 14 |
| EG001 | Treadmill Robot Training (TMR) | Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training. | 0 | 14 | 9 | 14 |
| EG002 | Trll Only (TMO) | Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period. Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period. | 1 | 6 | 0 | 6 |
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| Ankle sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject sprained ankle during baseline gait assessment. Returned and completed study. |
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| Chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject reported chest pain at home and was seen at local hospital. Report indicated pain was not study related and musculoskeletal in nature. |
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| Skin abrasion | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Early sessions of TMR could evoke excessive rubbing at robot contact points; resolved with extra padding. |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Retention at 12 weeks |
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| 12 week Retention |
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| Retention at 12 weeks |
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