Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke (Robot3)
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 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|
- 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
|Study Start Date:||January 2009|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244243
|United States, California|
|University of California, Irvine|
|Irvine, California, United States, 92697|
|Principal Investigator:||Steven C Cramer, MD||University of Californai Irvine|