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Evaluation of Robot Assisted Neuro-Rehabilitation (SRT3)

This study has been completed.
Sponsor:
Collaborators:
Massachusetts Institute of Technology
University of Maryland
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01253018
First received: November 24, 2010
Last updated: February 1, 2016
Last verified: February 2016
Results First Received: December 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stroke
Interventions: Behavioral: Robot Therapy
Behavioral: Transition to Task Training

  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 occurred between April 2011 and March 2014. The study location was a clinical research setting within the Veterans Affairs Maryland Health Care System.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
14 enrolled participants were withdrawn prior to randomization due to not meeting FM inclusion criteria, or due to medical or social issues.

Reporting Groups
  Description
Robot Therapy 12 weeks of robot-assisted upper extremity exercise using 2 different robots in a sequential 4 week progression in 3 distinct modules: wrist, shoulder-elbow and alternating sessions of wrist and shoulder-elbow robot. Sessions were 3x/week x 60 minutes.
Transition to Task Training 12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)

Participant Flow:   Overall Study
    Robot Therapy     Transition to Task Training  
STARTED     22     23  
COMPLETED     18     21  
NOT COMPLETED     4     2  
Lost to Follow-up                 1                 1  
Robot Repair Issues                 2                 0  
Withdrawal by Subject                 1                 1  



  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.
Age, gender, race/ethnicity, type of stroke.

Reporting Groups
  Description
Robot Therapy 12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
Transition to Task Training 12 weeks of robot-assisted upper extremity exercise as described in Robot Therapy combined with transition to task (TTT) practice of functional activities using the hemiparetic arm. Sessions were 3x/week x 60 minutes (45 min robot therapy + 15 min TTT)
Total Total of all reporting groups

Baseline Measures
    Robot Therapy     Transition to Task Training     Total  
Number of Participants  
[units: participants]
  22     23     45  
Age  
[units: years]
Mean (Standard Deviation)
  55.7  (10.2)     56.4  (12.7)     56.1  (11.4)  
Gender  
[units: participants]
     
Female     8     8     16  
Male     14     15     29  
Race/Ethnicity, Customized  
[units: participants]
     
White     7     14     21  
Black or African American     14     8     22  
Asian Indian     0     1     1  
Hispanic     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     22     23     45  
Type of Stroke  
[units: participants]
     
Ishemic     18     19     37  
Hemorrhagic     4     4     8  



  Outcome Measures
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1.  Primary:   Fugl-Meyer Motor Upper Extremity Assessment   [ Time Frame: Baseline, 12 week, and 24 week retention ]

2.  Secondary:   Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS)   [ Time Frame: week 12 ]

3.  Secondary:   Wolf Motor Function Test (WMFT)   [ Time Frame: Baseline, 12 week, and 24 week retention ]

4.  Secondary:   Stroke Impact Scale: Hand Subscale   [ Time Frame: Baseline, 12 week and 24 week retention ]


  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 amount of change on our primary outcome measure (FM) for this population of stroke survivors with moderated to severe upper extremity motor impairment was less than predicted (4 points vs. 8) resulting in the study groups being underpowered.


  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: Dr. Christopher T. Bever, Jr. MD, MBA
Organization: VA Maryland Health Care System
phone: (410) 605-7000 ext 7130
e-mail: christopher.bever@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01253018     History of Changes
Other Study ID Numbers: B6935-R
Study First Received: November 24, 2010
Results First Received: December 1, 2015
Last Updated: February 1, 2016
Health Authority: United States: Federal Government