Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke

Stroke Clinical Trial

— Robot3  

Official title:

Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244243
• Other study ID #: HS#2004-3852
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2010
• Last updated: August 16, 2016
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: August 2016
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	change from baseline to 1 month post-end treatment, Intention To Treat	No
Primary	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.	change from baseline to 1 month post-end treatment, Intention To Treat	No

External Links

•   Hand & Wrist Assisting Robotic Device