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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01244243
First received: November 3, 2010
Last updated: August 16, 2016
Last verified: August 2016
  Purpose
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
Stroke
Device: Hand & Wrist Assisting Robotic Device
Phase 2

Study Type: Interventional
Study Design: 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: change from baseline to 1 month post-end treatment, Intention To Treat ] [ Designated as safety issue: No ]
    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.

  • Arm Motor Fugl-Meyer Test [ Time Frame: change from baseline to 1 month post-end treatment, Intention To Treat ] [ Designated as safety issue: No ]
    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.


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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01244243

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

Additional Information:
Responsible Party: Steven C. Cramer, MD, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01244243     History of Changes
Other Study ID Numbers: HS#2004-3852 
Study First Received: November 3, 2010
Results First Received: December 12, 2014
Last Updated: August 16, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
stroke
rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 23, 2016