Ankle Robotics Training After Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01337960
First received: April 15, 2011
Last updated: May 27, 2015
Last verified: May 2015
Results First Received: April 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment from greater Baltimore area was from IRB approved stroke registry and word of mouth

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Seated Robot Training (SRT)     Treadmill Robot Training (TMR)     Treadmill Only (TMO)  
STARTED     14     14     6  
COMPLETED     12     14     6  
NOT COMPLETED     2     0     0  
Lost to Follow-up                 1                 0                 0  
Withdrawal by Subject                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Groups were compared at baseline using Friedmans test and Wilcoxon Sign Rank tests

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
    Seated Robot Training (SRT)     Treadmill Robot Training (TMR)     Treadmill Only (TMO)     Total  
Number of Participants  
[units: participants]
  14     14     6     34  
Age  
[units: years]
Mean (Standard Deviation)
  56.8  (13.2)     59.5  (15.3)     56.7  (15.2)     57.8  (11.1)  
Gender  
[units: participants]
       
Female     4     5     1     10  
Male     10     9     5     24  
Region of Enrollment  
[units: participants]
       
United States     14     14     6     34  



  Outcome Measures
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1.  Primary:   Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention   [ Time Frame: Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) ]

2.  Secondary:   Gait Kinetics   [ Time Frame: Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) ]

3.  Secondary:   Berg Balance Scale   [ Time Frame: Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) ]

4.  Secondary:   Dynamic Gait Index   [ Time Frame: Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) ]

5.  Secondary:   Anticipatory Postural Adjustments   [ Time Frame: Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: Larry.Forrester@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01337960     History of Changes
Other Study ID Numbers: A7461-P
Study First Received: April 15, 2011
Results First Received: April 28, 2015
Last Updated: May 27, 2015
Health Authority: United States: Federal Government