Seated Treadmill Training, Treadmill Locomotor-based Training, Treadmill Only
Conditions
Keywords
Stroke, Robotics, Neurorehabilitation
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSeated 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.
BEHAVIORALTreadmill 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.
BEHAVIORALTreadmill 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.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Ischemic or hemorrhagic stroke \>6 months prior in men or women aged between 18-80 years. * Clear indications of hemiparetic gait by clinical observation. * Completed all conventional physical therapy. * Ability to walk on a treadmill with handrail support.
Exclusion criteria
* Cardiac history of (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); (c) hemodynamically significant valvular dysfunction. * Major clinical depression: CESD score \> 16 and judgment of clinical depression * Medical History: (a) recent hospitalization (less than 3 months) for severe medical disease, (b) symptomatic peripheral arterial occlusive disease, (c) orthopedic or chronic pain conditions that significantly alter gait function, (d) pulmonary or renal failure (e) active cancer * History of non-stroke neuromuscular disorder restricting gait. * Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands. The Mini Mental State Exam will be administered with a cut-off of less than 23 (less than 17 if education level at or below 8th grade), or judgment of the medical officer. * Hypertension that is a contraindication for a bout of treadmill training (greater than 160/100 on two assessments). * Self-report of pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) | Velocity and associated spatio-temporal gait parameters from self-selected most comfortable and fastest floor walking over 10m. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Kinetics | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) | Anterior-posterior and medio-lateral ground reaction forces during walking to assess propulsive impulses from paretic and nonparetic sides. |
| Berg Balance Scale | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention 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. |
| Dynamic Gait Index | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) | 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. |
| Anticipatory Postural Adjustments | Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) | During gait initiation two force plates measure ground reaction forces and impulses for the postural shifts made in preparation to begin walking. |
Countries
United States
Participant flow
Recruitment details
Recruitment from greater Baltimore area was from IRB approved stroke registry and word of mouth
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 14 |
| 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. | 6 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Seated Robot Training (SRT) | Treadmill Robot Training (TMR) | Treadmill Only (TMO) | Total |
|---|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 13.2 | 59.5 years STANDARD_DEVIATION 15.3 | 56.7 years STANDARD_DEVIATION 15.2 | 57.8 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 14 participants | 14 participants | 6 participants | 34 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 5 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 14 | 9 / 14 | 0 / 6 |
| serious Total, serious adverse events | 2 / 14 | 0 / 14 | 1 / 6 |
Outcome results
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.
Time frame: Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)
Population: Nonparametric Fisher's exact test was applied to compare between group changes at retention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seated Robot Training (SRT) | Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention | Post-test Training | 56.1 cm/sec | Standard Error 8.5 |
| Seated Robot Training (SRT) | Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention | Baseline | 56.0 cm/sec | Standard Error 8.3 |
| Seated Robot Training (SRT) | Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention | Retention at 12 weeks | 50.9 cm/sec | Standard Error 7.8 |
| Treadmill Robot Training (TMR) | Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention | Post-test Training | 58.6 cm/sec | Standard Error 5.5 |
| Treadmill Robot Training (TMR) | Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention | Baseline | 55.5 cm/sec | Standard Error 5.7 |
| Treadmill Robot Training (TMR) | Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention | Retention at 12 weeks | 61.5 cm/sec | Standard Error 5.6 |
| Treadmill Only (TMO) | Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention | Baseline | 50.9 cm/sec | Standard Error 5.3 |
| Treadmill Only (TMO) | Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention | Retention at 12 weeks | NA cm/sec | — |
| Treadmill Only (TMO) | Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention | Post-test Training | 57.8 cm/sec | Standard Error 16.5 |
p-value: <0.01Fisher Exact
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.
Time frame: Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)
Population: These data were not collected due to technical issues.
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.
Time frame: Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)
Population: Nonparametric Fisher's exact test was applied to compare between group changes at retention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seated Robot Training (SRT) | Berg Balance Scale | 12 week Retention | 45.1 units on a scale | Standard Error 3.6 |
| Seated Robot Training (SRT) | Berg Balance Scale | Post-test Training | 45.7 units on a scale | Standard Error 3 |
| Seated Robot Training (SRT) | Berg Balance Scale | Baseline | 44.3 units on a scale | Standard Error 3 |
| Treadmill Robot Training (TMR) | Berg Balance Scale | 12 week Retention | 48.8 units on a scale | Standard Error 1.9 |
| Treadmill Robot Training (TMR) | Berg Balance Scale | Baseline | 49.1 units on a scale | Standard Error 1.5 |
| Treadmill Robot Training (TMR) | Berg Balance Scale | Post-test Training | 49.7 units on a scale | Standard Error 1.5 |
| Treadmill Only (TMO) | Berg Balance Scale | Post-test Training | 47.4 units on a scale | Standard Error 2.5 |
| Treadmill Only (TMO) | Berg Balance Scale | Baseline | 48.4 units on a scale | Standard Error 1.9 |
| Treadmill Only (TMO) | Berg Balance Scale | 12 week Retention | NA units on a scale | — |
p-value: =0.17Fisher Exact
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.
Time frame: Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)
Population: Nonparametric Fisher's exact test was applied to compare between group changes at retention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seated Robot Training (SRT) | Dynamic Gait Index | Post-test Training | 16.4 units on a scale | Standard Error 1.3 |
| Seated Robot Training (SRT) | Dynamic Gait Index | Baseline | 14.4 units on a scale | Standard Error 1.8 |
| Seated Robot Training (SRT) | Dynamic Gait Index | Retention at 12 weeks | 17.3 units on a scale | Standard Error 1.1 |
| Treadmill Robot Training (TMR) | Dynamic Gait Index | Post-test Training | 18.8 units on a scale | Standard Error 0.8 |
| Treadmill Robot Training (TMR) | Dynamic Gait Index | Baseline | 17.4 units on a scale | Standard Error 0.9 |
| Treadmill Robot Training (TMR) | Dynamic Gait Index | Retention at 12 weeks | 18.7 units on a scale | Standard Error 0.9 |
| Treadmill Only (TMO) | Dynamic Gait Index | Baseline | 17.0 units on a scale | Standard Error 1.1 |
| Treadmill Only (TMO) | Dynamic Gait Index | Retention at 12 weeks | NA units on a scale | — |
| Treadmill Only (TMO) | Dynamic Gait Index | Post-test Training | 18.4 units on a scale | Standard Error 1.8 |
p-value: =0.35Fisher Exact
Secondary
Gait Kinetics
Anterior-posterior and medio-lateral ground reaction forces during walking to assess propulsive impulses from paretic and nonparetic sides.
Time frame: Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)
Population: Nonparametric Fisher's exact test was applied to compare between group changes at retention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seated Robot Training (SRT) | Gait Kinetics | Retention at 12 weeks | 4.1 Newton-seconds | Standard Error 5.6 |
| Seated Robot Training (SRT) | Gait Kinetics | Post-test Training | 0.7 Newton-seconds | Standard Error 5.1 |
| Seated Robot Training (SRT) | Gait Kinetics | Baseline | 2.1 Newton-seconds | Standard Error 4.8 |
| Treadmill Robot Training (TMR) | Gait Kinetics | Post-test Training | 9.6 Newton-seconds | Standard Error 4.1 |
| Treadmill Robot Training (TMR) | Gait Kinetics | Baseline | -2.5 Newton-seconds | Standard Error 4.9 |
| Treadmill Robot Training (TMR) | Gait Kinetics | Retention at 12 weeks | 16.7 Newton-seconds | Standard Error 6 |
| Treadmill Only (TMO) | Gait Kinetics | Baseline | -8.8 Newton-seconds | Standard Error 5.9 |
| Treadmill Only (TMO) | Gait Kinetics | Retention at 12 weeks | NA Newton-seconds | — |
| Treadmill Only (TMO) | Gait Kinetics | Post-test Training | -10.1 Newton-seconds | Standard Error 6.4 |
p-value: <0.02Fisher Exact