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Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients (VA ROBOTICS)

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ClinicalTrials.gov Identifier: NCT00372411
Recruitment Status : Completed
First Posted : September 7, 2006
Results First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Sponsor:
Collaborator:
Burke Medical Research Institute
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stroke
Interventions: Device: Robot-Assisted Therapy - MIT-MANUS System
Other: Intensive Comparison Therapy
Other: Usual Care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between 11-8-06 and 10-31-08, 200 were screened and 127 randomized from 4 VA medical centers: Gainesville, West Haven, Baltimore, and Seattle. Usual care enrollment was stopped after 15 months when target information was attained per protocol. Recruitment to the robot-assisted and intensive comparison groups continued for 24 months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Robot-assisted Therapy Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
Intensive Comparison Therapy Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
Usual Care Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.

Participant Flow:   Overall Study
    Robot-assisted Therapy   Intensive Comparison Therapy   Usual Care
STARTED   49   50   28 
COMPLETED   44   42   25 
NOT COMPLETED   5   8   3 
Withdrawal by Subject                3                4                1 
Death                0                2                1 
Lost to Follow-up                1                1                1 
Adverse Event                1                1                0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Robot-assisted Therapy Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
Intensive Comparison Therapy Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
Usual Care Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Total Total of all reporting groups

Baseline Measures
   Robot-assisted Therapy   Intensive Comparison Therapy   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   50   28   127 
Age 
[Units: Years]
Mean (Standard Deviation)
 66  (11)   64  (11)   63  (12)   65  (11) 
Gender 
[Units: Participants]
       
Female   2   2   1   5 
Male   47   48   27   122 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   1   2   0   3 
Not Hispanic or Latino   48   48   28   124 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   0   1   0   1 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   10   12   5   27 
White   38   35   23   96 
More than one race   1   2   0   3 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   49   50   28   127 
Index Stroke Type 
[Units: Participants]
       
Hemorrhagic   7   6   6   19 
Ischemic   42   44   22   108 
Index Stroke Location 
[Units: Participants]
       
Anterior circulation ≥1/3 of hemisphere   6   14   6   26 
Anterior circulation <1/3 of hemisphere   17   21   10   48 
Small deep infarct   17   15   6   38 
Posterior circulation   9   0   6   15 
Time from Index Stroke to Randomization 
[Units: Years]
Mean (Standard Deviation)
 3.6  (4.0)   4.8  (4.0)   6.2  (5.0)   4.7  (4.2) 
Fugl-Meyer Assessment [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 19.7  (10.7)   17.3  (8.4)   20.3  (9.0)   18.9  (9.5) 
[1] Primary outcome baseline scores
Comorbidity Disease Index [1] 
[Units: Participants]
       
≤1 Domain   7   7   2   16 
2 Domains   13   24   8   45 
≥3 Domains   29   19   18   66 
[1] The Comorbidity Disease Index domains include cardiac, respiratory, neurologic, musculoskeletal, general (mental or emotional problems and sleep or pain disorders), cancer, diabetes, and visual problems. The domain scores are totaled to create an overall comorbidity score (≤1, 2, or ≥3 domains).


  Outcome Measures

1.  Primary:   Fugl-Meyer Assessment for Motor Recovery (FM) Scale   [ Time Frame: 6, 12, 24 and 36 weeks minus baseline ]

2.  Secondary:   Stroke Impact Scale   [ Time Frame: 6, 12, 24 and 36 weeks minus baseline ]

3.  Secondary:   Wolf Motor Function Test   [ Time Frame: 6, 12, 24 and 36 weeks minus baseline ]

4.  Secondary:   Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline   [ Time Frame: 12 weeks minus baseline ]

5.  Secondary:   Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline   [ Time Frame: 12 weeks minus baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Peter Guarino, MPH, PhD, Director, WH-CSPCC
Organization: Dept. of Veterans Affairs, Cooperative Studies Program, West Haven, CT
phone: 203-932-5711 ext 3780
e-mail: peter.guarino@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00372411     History of Changes
Other Study ID Numbers: 558
First Submitted: September 5, 2006
First Posted: September 7, 2006
Results First Submitted: September 4, 2013
Results First Posted: January 13, 2014
Last Update Posted: January 13, 2014