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Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke (Robot3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01244243
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : May 27, 2015
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stroke
Intervention Device: Hand & Wrist Assisting Robotic Device
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Therapy
Hide Arm/Group Description All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
Period Title: Overall Study
Started 41
Completed 41
Not Completed 0
Arm/Group Title Active Therapy
Hide Arm/Group Description

All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.

Hand & Wrist Assisting Robotic Device: Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks.

Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
  73.2%
>=65 years
11
  26.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
59  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
11
  26.8%
Male
30
  73.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants
41
1.Primary Outcome
Title Action Research Arm Test
Hide Description The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.
Time Frame change from baseline to 1 month post-end treatment, Intention To Treat
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Therapy
Hide Arm/Group Description:
All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.1
(2.3 to 5.9)
2.Primary Outcome
Title Arm Motor Fugl-Meyer Test
Hide Description The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement.
Time Frame change from baseline to 1 month post-end treatment, Intention To Treat
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Therapy
Hide Arm/Group Description:
All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
Overall Number of Participants Analyzed 41
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.7
(2.7 to 4.8)
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Therapy
Hide Arm/Group Description All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
All-Cause Mortality
Active Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Therapy
Affected / at Risk (%)
Total   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Therapy
Affected / at Risk (%)
Total   0/41 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Steve Cramer
Organization: University of California, Irvine
Phone: 7144566876
Responsible Party: Steven C. Cramer, MD, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01244243     History of Changes
Other Study ID Numbers: HS#2004-3852
First Submitted: November 3, 2010
First Posted: November 19, 2010
Results First Submitted: December 12, 2014
Results First Posted: May 27, 2015
Last Update Posted: August 18, 2016