Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke

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.

Completed

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, Irvine

Irvine, California, 92697, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand & Wrist Assisting Robotic Device

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

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Acronym: Robot3

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Nov 19, 2010
Registry last updated: Aug 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed