Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke (Robot3)
Primary Purpose
Stroke
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hand & Wrist Assisting Robotic Device
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, rehabilitation
Eligibility Criteria
Inclusion Criteria:
- At least 18 years old
- Had stroke between 11-26 weeks ago
- Have some weakness in one of your wrists or hands due to stroke
- Did not have too much disability prior to stroke
- Do not have major depression
Exclusion Criteria:
- Non-English speaking
- If you have trouble keeping good attention
- Pregnant, advanced liver, kidney, heart, or lung disease
- Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke
- Cannot undergo MRI scanning
- Have history of brain surgery or seizures
Sites / Locations
- University of California, Irvine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active therapy
Arm 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.
Outcomes
Primary Outcome Measures
Action Research Arm Test
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01244243
First Posted
November 3, 2010
Last Updated
August 16, 2016
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT01244243
Brief Title
Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke
Acronym
Robot3
Official Title
Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Hand & Wrist Assisting Robotic Device
Other Intervention Name(s)
HWARD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Action Research Arm Test
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
Title
Arm Motor Fugl-Meyer Test
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years old
Had stroke between 11-26 weeks ago
Have some weakness in one of your wrists or hands due to stroke
Did not have too much disability prior to stroke
Do not have major depression
Exclusion Criteria:
Non-English speaking
If you have trouble keeping good attention
Pregnant, advanced liver, kidney, heart, or lung disease
Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke
Cannot undergo MRI scanning
Have history of brain surgery or seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven C Cramer, MD
Organizational Affiliation
University of Californai Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28483654
Citation
McKenzie A, Dodakian L, See J, Le V, Quinlan EB, Bridgford C, Head D, Han VL, Cramer SC. Validity of Robot-Based Assessments of Upper Extremity Function. Arch Phys Med Rehabil. 2017 Oct;98(10):1969-1976.e2. doi: 10.1016/j.apmr.2017.02.033. Epub 2017 May 5.
Results Reference
derived
Learn more about this trial
Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke
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