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Robot-Assisted Motivating Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00393926
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : February 4, 2014
American Heart Association
Information provided by (Responsible Party):
Michelle J. Johnson, Medical College of Wisconsin

Brief Summary:
The purpose of the study is to examine how a novel robot technology designed for eventual use as a home therapy can improve arm function after stroke.

Condition or disease Intervention/treatment Phase
Stroke Cerebrovascular Accident Device: TheraDrive Assistive Device Procedure: Rote Therapy versus Fun Therapy Phase 1

Detailed Description:

Typically, after brain damage due to a stroke, the affected arm is weak and suffering from some of paralysis. As a result, adults with this condition are unable to move their impaired arm well during their activities of daily living. Our research is focused on understanding how best to improve the ability of the arm to move after brain damage due to a stroke. We have implemented novel robot technology designed for eventual use as a home therapy device and have used software and hardware technologies to design activities that can assess the arm ability and engage the person during therapy. We will study how the prolong use of this device with simple, functional, and engaging activities improve the arm's movement ability and sustain motivation to use the arm over repeated therapy sessions and away from supervision.

Overall, we will establish whether using our technology to perform tasks that are more or less game-like and functionally relevant to driving will make a difference in the impaired arm after stroke. Two groups of stroke survivors will be followed while they complete therapy. We have three main aims. In aim #1, we will determine whether therapy using functional tasks compared to simple rote tasks lead to significant increases in the use of the arm during therapy and the arm improvements experienced by the subjects after the therapy. In aim #2, we will measure how each group engage in the more and less functional therapy and monitor their effort and enjoyment during training. This aim will help us to determine the value of more fun training. In aim #3, we will upgrade our technology for use in the home therapy environment and follow some subjects to determine if the results change in under supervised condition (at home)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robot-Assisted Motivating Rehabilitation to Increase Upper Limb Function After Stroke
Study Start Date : July 2006
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Subjects will be included in the study on the basis of the following criteria:

  • They must be at least six months post-stroke.
  • 18 years of age or older with a clinical diagnosis of hemiparesis (as verified by medical record and a medical expert).
  • They have voluntary control with a low to medium range of motion function (UE-FT<5) and a muscle tone.
  • They are functionally stable (no significant changes in motor function over a week) and are able to tolerate being seated upright for 90 minutes.
  • They report no excessive pain the impaired arm.
  • If left neglect or spasticity is detected in the impaired arm, these levels must not interfere with the ability to cognitively complete the tasks or turn a wheel.
  • They must not be participating in any experimental rehabilitation or drug therapies.
  • If subjects are receiving chemical injections for spasticity, they must be at least 3-months away from their last treatment.
  • They must have driven prior to stroke.
  • They are not clinically depressed (as measured by the Geriatric Depression Scale (GDS) short form (Sheikh and Yesavage, 1986).

Exclusion Criteria:

  • Subjects will be excluded from the study if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.

Once informed consent is given twenty-four of these subjects will be randomized into two training groups (fun driving: fun and functional driving activities and rote tracking (12 subjects): rote and functional tracking activities). Two subjects will be randomized the case study group. The groups will be matched in initial motor function.

Subjects will be excluded if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00393926

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United States, Wisconsin
Clement J Zablocki VA - Rehabilitation Robotics R&D Lab
Milwaukee, Wisconsin, United States, 53295
Sponsors and Collaborators
Medical College of Wisconsin
American Heart Association
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Principal Investigator: Michelle J Johnson, PhD Medical College of Wisconsin
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Responsible Party: Michelle J. Johnson, Adjunct Associate Professor, Medical College of Wisconsin Identifier: NCT00393926    
Other Study ID Numbers: 0635450Z
First Posted: October 31, 2006    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014
Keywords provided by Michelle J. Johnson, Medical College of Wisconsin:
Upper Extremity
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases