Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine Identifier:
First received: November 3, 2010
Last updated: November 7, 2013
Last verified: November 2013

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 Intervention Phase
Device: Hand & Wrist Assisting Robotic Device
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Action Research Arm Test [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    an observational test used to determine upper limb function.

  • Arm Motor Fugl-Meyer Test [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    Assessment of Sensorimotor Recovery After Stroke

Enrollment: 41
Study Start Date: January 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01244243

United States, California
University of California, Irvine
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Principal Investigator: Steven C Cramer, MD University of Californai Irvine
  More Information

Additional Information:
No publications provided

Responsible Party: Steven C. Cramer, MD, Professor, University of California, Irvine Identifier: NCT01244243     History of Changes
Other Study ID Numbers: HS#2004-3852
Study First Received: November 3, 2010
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Additional relevant MeSH terms:
Cerebral Infarction
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases processed this record on November 24, 2014