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Ankle Robotics Training After Stroke

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ClinicalTrials.gov Identifier: NCT01337960
Recruitment Status : Completed
First Posted : April 19, 2011
Results First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor)
Conditions Seated Treadmill Training
Treadmill Locomotor-based Training
Treadmill Only
Interventions Behavioral: Seated Robot Training (SRT)
Behavioral: Treadmill Locomotor-based Training (TMR)
Behavioral: Treadmill Only (TMO)
Enrollment 41
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.
Arm/Group Title Seated Robot Training (SRT) Treadmill Robot Training (TMR) Treadmill Only (TMO)
Hide Arm/Group Description

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 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 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.

Period Title: Overall Study
Started 14 14 6
Completed 12 14 6
Not Completed 2 0 0
Reason Not Completed
Lost to Follow-up             1             0             0
Withdrawal by Subject             1             0             0
Arm/Group Title Seated Robot Training (SRT) Treadmill Robot Training (TMR) Treadmill Only (TMO) Total
Hide Arm/Group Description

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 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 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 of all reporting groups
Overall Number of Baseline Participants 14 14 6 34
Hide Baseline Analysis Population Description
Groups were compared at baseline using Friedmans test and Wilcoxon Sign Rank tests
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 6 participants 34 participants
56.8  (13.2) 59.5  (15.3) 56.7  (15.2) 57.8  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 6 participants 34 participants
Female
4
  28.6%
5
  35.7%
1
  16.7%
10
  29.4%
Male
10
  71.4%
9
  64.3%
5
  83.3%
24
  70.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 14 participants 6 participants 34 participants
14 14 6 34
1.Primary Outcome
Title Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Nonparametric Fisher's exact test was applied to compare between group changes at retention.
Arm/Group Title Seated Robot Training (SRT) Treadmill Robot Training (TMR) Treadmill Only (TMO)
Hide Arm/Group Description:

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 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 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 Number of Participants Analyzed 12 14 6
Mean (Standard Error)
Unit of Measure: cm/sec
Baseline 56.0  (8.3) 55.5  (5.7) 50.9  (5.3)
Post-test Training 56.1  (8.5) 58.6  (5.5) 57.8  (16.5)
Retention at 12 weeks 50.9  (7.8) 61.5  (5.6) NA [1]   (NA)
[1]
Controls were in an ongoing treadmill study and could not stop training during the retention period.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Seated Robot Training (SRT), Treadmill Robot Training (TMR)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.01
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Gait Kinetics
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Nonparametric Fisher's exact test was applied to compare between group changes at retention.
Arm/Group Title Seated Robot Training (SRT) Treadmill Robot Training (TMR) Treadmill Only (TMO)
Hide Arm/Group Description:

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 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 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 Number of Participants Analyzed 12 14 6
Mean (Standard Error)
Unit of Measure: Newton-seconds
Baseline 2.1  (4.8) -2.5  (4.9) -8.8  (5.9)
Post-test Training 0.7  (5.1) 9.6  (4.1) -10.1  (6.4)
Retention at 12 weeks 4.1  (5.6) 16.7  (6.0) NA [1]   (NA)
[1]
Controls were in an ongoing treadmill study and could not stop training during the retention period.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Seated Robot Training (SRT), Treadmill Robot Training (TMR)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.02
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Berg Balance Scale
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Nonparametric Fisher's exact test was applied to compare between group changes at retention.
Arm/Group Title Seated Robot Training (SRT) Treadmill Robot Training (TMR) Treadmill Only (TMO)
Hide Arm/Group Description:

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 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 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 Number of Participants Analyzed 12 14 6
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 44.3  (3.0) 49.1  (1.5) 48.4  (1.9)
Post-test Training 45.7  (3.0) 49.7  (1.5) 47.4  (2.5)
12 week Retention 45.1  (3.6) 48.8  (1.9) NA [1]   (NA)
[1]
Controls were in an ongoing treadmill study and could not stop training during the retention period.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Seated Robot Training (SRT), Treadmill Robot Training (TMR)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.17
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Dynamic Gait Index
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Nonparametric Fisher's exact test was applied to compare between group changes at retention.
Arm/Group Title Seated Robot Training (SRT) Treadmill Robot Training (TMR) Treadmill Only (TMO)
Hide Arm/Group Description:

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 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 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 Number of Participants Analyzed 12 14 6
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 14.4  (1.8) 17.4  (0.9) 17.0  (1.1)
Post-test Training 16.4  (1.3) 18.8  (0.8) 18.4  (1.8)
Retention at 12 weeks 17.3  (1.1) 18.7  (0.9) NA [1]   (NA)
[1]
Controls were in an ongoing treadmill study and could not stop training during the retention period.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Seated Robot Training (SRT), Treadmill Robot Training (TMR)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.35
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Anticipatory Postural Adjustments
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These data were not collected due to technical issues.
Arm/Group Title Seated Robot Training (SRT) Treadmill Robot Training (TMR) Treadmill Only (TMO)
Hide Arm/Group Description:

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 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 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 Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year, 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Seated Robot Training (SRT) Treadmill Robot Training (TMR) Trll Only (TMO)
Hide Arm/Group Description

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 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 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.

All-Cause Mortality
Seated Robot Training (SRT) Treadmill Robot Training (TMR) Trll Only (TMO)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Seated Robot Training (SRT) Treadmill Robot Training (TMR) Trll Only (TMO)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/14 (14.29%)      0/14 (0.00%)      1/6 (16.67%)    
Musculoskeletal and connective tissue disorders       
Ankle sprain * [1]  1/14 (7.14%)  1 0/14 (0.00%)  0 0/6 (0.00%)  0
Chest pain * [2]  0/14 (0.00%)  0 0/14 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders       
Jacksonian Seizure * [3]  1/14 (7.14%)  1 0/14 (0.00%)  0 0/6 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Subject sprained ankle during baseline gait assessment. Returned and completed study.
[2]
Subject reported chest pain at home and was seen at local hospital. Report indicated pain was not study related and musculoskeletal in nature.
[3]
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.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Seated Robot Training (SRT) Treadmill Robot Training (TMR) Trll Only (TMO)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/14 (21.43%)      9/14 (64.29%)      0/6 (0.00%)    
Musculoskeletal and connective tissue disorders       
Muscle soreness * [1]  3/14 (21.43%)  3 7/14 (50.00%)  13 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin abrasion * [2]  0/14 (0.00%)  0 7/14 (50.00%)  13 0/6 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Was more common in early sessions with treadmill + robotics (TMR) as they had more vigorous exercise, resolved in 1-2 days.
[2]
Early sessions of TMR could evoke excessive rubbing at robot contact points; resolved with extra padding.
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Larry Forrester, PhD
Organization: VA Maryland Health Care System
Phone: 410-637-3241
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT01337960     History of Changes
Other Study ID Numbers: A7461-P
First Submitted: April 15, 2011
First Posted: April 19, 2011
Results First Submitted: April 28, 2015
Results First Posted: June 12, 2015
Last Update Posted: June 12, 2015