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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. Identifier: NCT01244243
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : May 27, 2015
Last Update Posted : August 18, 2016
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine

Brief Summary:
The purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response.

Condition or disease Intervention/treatment Phase
Stroke Device: Hand & Wrist Assisting Robotic Device Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke
Study Start Date : January 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Active therapy
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.
Device: Hand & Wrist Assisting Robotic Device
Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks. In each treatment session, you will sit in a chair and have your weak hand attached to a mechanical device (the robot), which will help you open and close your hand. During the treatment, different types of objects (with varying shapes, sizes, and weight) will be placed into your hand. You will be given a variety of instructions related to the grasping, feeling, or identifying of the object in your hand. Sometimes these instructions will be given from the investigator and sometimes from the computer. You will often be asked to grasp, or release, each of these objects as best you can. You will also be asked to concentrate on the object in your hand. An example of what you may be asked to do is to name the object. During other times, you will play games, using the robot to control game parts on the computer screen. At other times, you will move your hand so that the robot can measure your hand function.
Other Name: HWARD

Primary Outcome Measures :
  1. Action Research Arm Test [ Time Frame: change from baseline to 1 month post-end treatment, Intention To Treat ]
    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.

  2. Arm Motor Fugl-Meyer Test [ Time Frame: change from baseline to 1 month post-end treatment, Intention To Treat ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. At least 18 years old
  2. Had stroke between 11-26 weeks ago
  3. Have some weakness in one of your wrists or hands due to stroke
  4. Did not have too much disability prior to stroke
  5. Do not have major depression

Exclusion Criteria:

  1. Non-English speaking
  2. If you have trouble keeping good attention
  3. Pregnant, advanced liver, kidney, heart, or lung disease
  4. Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke
  5. Cannot undergo MRI scanning
  6. Have history of brain surgery or seizures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01244243

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United States, California
University of California, Irvine
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
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Principal Investigator: Steven C Cramer, MD University of Californai Irvine
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Steven C. Cramer, MD, Professor, University of California, Irvine Identifier: NCT01244243    
Other Study ID Numbers: HS#2004-3852
First Posted: November 19, 2010    Key Record Dates
Results First Posted: May 27, 2015
Last Update Posted: August 18, 2016
Last Verified: August 2016
Keywords provided by Steven C. Cramer, MD, University of California, Irvine:
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases