Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke

NCT01244243 | Completed Phase 2 Results

• 1 other identifier: HS#2004-3852
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Active therapy

EXPERIMENTAL

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

Interventions

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.

Also known as: HWARD

Active therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (1)

• 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.

  PMID: 28483654 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Steve Cramer
• Organization: University of California, Irvine

scramer@uci.edu

7144566876

Study Officials

• Steven C Cramer, MD

  University of Californai Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 19, 2010
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 18, 2016
• Results First Posted: May 27, 2015

Record last verified: 2016-08

Locations

US (1)