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

August 16, 2016 updated by: Steven C. Cramer, MD, University of California, Irvine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • University of California, Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • HWARD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline to 1 month post-end treatment, Intention To Treat
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.
change from baseline to 1 month post-end treatment, Intention To Treat

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Steven C Cramer, MD, University of Californai Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 17, 2010

First Posted (Estimate)

November 19, 2010

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS#2004-3852

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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