Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke

NCT ID: NCT01244243

Last Updated: 2016-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hand & Wrist Assisting Robotic Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

HWARD

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Steven C. Cramer, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven C Cramer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Californai Irvine

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28483654 (View on PubMed)

Other Identifiers

HS#2004-3852

Identifier Type: -

Identifier Source: org_study_id