Robot-Assisted Motivating Rehabilitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Medical College of Wisconsin.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American Heart Association
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00393926
First received: October 30, 2006
Last updated: November 26, 2008
Last verified: May 2007
  Purpose

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 Intervention Phase
Stroke
Cerebrovascular Accident
Device: TheraDrive Assistive Device
Procedure: Rote Therapy versus Fun Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Robot-Assisted Motivating Rehabilitation to Increase Upper Limb Function After Stroke

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Estimated Enrollment: 24
Study Start Date: July 2006
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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)

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393926

Contacts
Contact: Michelle J Johnson, PhD 414 384-2000 ext 45878 mjjohnso@mcw.edu
Contact: Rohit Rupharel 414 384-2000 ext 47171 rohitkirti.ruparel@marquette.edu

Locations
United States, Wisconsin
Clement J Zablocki VA - Rehabilitation Robotics R&D Lab Recruiting
Milwaukee, Wisconsin, United States, 53295
Contact: Michelle J Johnson, PhD     414-384-2000 ext 47170     mjjohnso@mcw.edu    
Sponsors and Collaborators
Medical College of Wisconsin
American Heart Association
Investigators
Principal Investigator: Michelle J Johnson, PhD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Michelle J. Johnson, PhD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00393926     History of Changes
Other Study ID Numbers: 0635450Z
Study First Received: October 30, 2006
Last Updated: November 26, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Robotics
Rehabilitation
Upper Extremity
CVA

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013