Trial Outcomes & Findings for Ankle Robotics Training After Stroke (NCT NCT01337960)
NCT ID: NCT01337960
Last Updated: 2015-06-12
Results Overview
Velocity and associated spatio-temporal gait parameters from self-selected most comfortable and fastest floor walking over 10m.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)
Results posted on
2015-06-12
Participant Flow
Recruitment from greater Baltimore area was from IRB approved stroke registry and word of mouth
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
6
|
|
Overall Study
COMPLETED
|
12
|
14
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Ankle Robotics Training After Stroke
Baseline characteristics by cohort
| Measure |
Seated Robot Training (SRT)
n=14 Participants
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.
|
Treadmill Robot Training (TMR)
n=14 Participants
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.
|
Treadmill Only (TMO)
n=6 Participants
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
6 participants
n=5 Participants
|
34 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Velocity and associated spatio-temporal gait parameters from self-selected most comfortable and fastest floor walking over 10m.
Outcome measures
| Measure |
Seated Robot Training (SRT)
n=12 Participants
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.
|
Treadmill Robot Training (TMR)
n=14 Participants
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.
|
Treadmill Only (TMO)
n=6 Participants
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.
|
|---|---|---|---|
|
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
|
61.5 cm/sec
Standard Error 5.6
|
NA cm/sec
Standard Error NA
Controls were in an ongoing treadmill study and could not stop training during the retention period.
|
|
Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention
Baseline
|
56.0 cm/sec
Standard Error 8.3
|
55.5 cm/sec
Standard Error 5.7
|
50.9 cm/sec
Standard Error 5.3
|
|
Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention
Post-test Training
|
56.1 cm/sec
Standard Error 8.5
|
58.6 cm/sec
Standard Error 5.5
|
57.8 cm/sec
Standard Error 16.5
|
SECONDARY outcome
Timeframe: 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.
Anterior-posterior and medio-lateral ground reaction forces during walking to assess propulsive impulses from paretic and nonparetic sides.
Outcome measures
| Measure |
Seated Robot Training (SRT)
n=12 Participants
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.
|
Treadmill Robot Training (TMR)
n=14 Participants
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.
|
Treadmill Only (TMO)
n=6 Participants
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.
|
|---|---|---|---|
|
Gait Kinetics
Baseline
|
2.1 Newton-seconds
Standard Error 4.8
|
-2.5 Newton-seconds
Standard Error 4.9
|
-8.8 Newton-seconds
Standard Error 5.9
|
|
Gait Kinetics
Post-test Training
|
0.7 Newton-seconds
Standard Error 5.1
|
9.6 Newton-seconds
Standard Error 4.1
|
-10.1 Newton-seconds
Standard Error 6.4
|
|
Gait Kinetics
Retention at 12 weeks
|
4.1 Newton-seconds
Standard Error 5.6
|
16.7 Newton-seconds
Standard Error 6.0
|
NA Newton-seconds
Standard Error NA
Controls were in an ongoing treadmill study and could not stop training during the retention period.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Seated Robot Training (SRT)
n=12 Participants
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.
|
Treadmill Robot Training (TMR)
n=14 Participants
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.
|
Treadmill Only (TMO)
n=6 Participants
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.
|
|---|---|---|---|
|
Berg Balance Scale
Baseline
|
44.3 units on a scale
Standard Error 3.0
|
49.1 units on a scale
Standard Error 1.5
|
48.4 units on a scale
Standard Error 1.9
|
|
Berg Balance Scale
Post-test Training
|
45.7 units on a scale
Standard Error 3.0
|
49.7 units on a scale
Standard Error 1.5
|
47.4 units on a scale
Standard Error 2.5
|
|
Berg Balance Scale
12 week Retention
|
45.1 units on a scale
Standard Error 3.6
|
48.8 units on a scale
Standard Error 1.9
|
NA units on a scale
Standard Error NA
Controls were in an ongoing treadmill study and could not stop training during the retention period.
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Seated Robot Training (SRT)
n=12 Participants
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.
|
Treadmill Robot Training (TMR)
n=14 Participants
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.
|
Treadmill Only (TMO)
n=6 Participants
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.
|
|---|---|---|---|
|
Dynamic Gait Index
Retention at 12 weeks
|
17.3 units on a scale
Standard Error 1.1
|
18.7 units on a scale
Standard Error 0.9
|
NA units on a scale
Standard Error NA
Controls were in an ongoing treadmill study and could not stop training during the retention period.
|
|
Dynamic Gait Index
Baseline
|
14.4 units on a scale
Standard Error 1.8
|
17.4 units on a scale
Standard Error 0.9
|
17.0 units on a scale
Standard Error 1.1
|
|
Dynamic Gait Index
Post-test Training
|
16.4 units on a scale
Standard Error 1.3
|
18.8 units on a scale
Standard Error 0.8
|
18.4 units on a scale
Standard Error 1.8
|
SECONDARY outcome
Timeframe: 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.
During gait initiation two force plates measure ground reaction forces and impulses for the postural shifts made in preparation to begin walking.
Outcome measures
Outcome data not reported
Adverse Events
Seated Robot Training (SRT)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Treadmill Robot Training (TMR)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Trll Only (TMO)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Seated Robot Training (SRT)
n=14 participants at risk
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.
|
Treadmill Robot Training (TMR)
n=14 participants at risk
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.
|
Trll Only (TMO)
n=6 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Jacksonian Seizure
|
7.1%
1/14 • Number of events 1 • 1 year, 9 months
|
0.00%
0/14 • 1 year, 9 months
|
0.00%
0/6 • 1 year, 9 months
|
|
Musculoskeletal and connective tissue disorders
Ankle sprain
|
7.1%
1/14 • Number of events 1 • 1 year, 9 months
|
0.00%
0/14 • 1 year, 9 months
|
0.00%
0/6 • 1 year, 9 months
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.00%
0/14 • 1 year, 9 months
|
0.00%
0/14 • 1 year, 9 months
|
16.7%
1/6 • Number of events 1 • 1 year, 9 months
|
Other adverse events
| Measure |
Seated Robot Training (SRT)
n=14 participants at risk
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.
|
Treadmill Robot Training (TMR)
n=14 participants at risk
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.
|
Trll Only (TMO)
n=6 participants at risk
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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle soreness
|
21.4%
3/14 • Number of events 3 • 1 year, 9 months
|
50.0%
7/14 • Number of events 13 • 1 year, 9 months
|
0.00%
0/6 • 1 year, 9 months
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/14 • 1 year, 9 months
|
50.0%
7/14 • Number of events 13 • 1 year, 9 months
|
0.00%
0/6 • 1 year, 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place