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Evaluating Error Augmentation for Neurorehabilitation (VREA)

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ClinicalTrials.gov Identifier: NCT01574495
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : September 24, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a sub-project of a larger NIDRR Grant. One promising form of robotic training that leverages the power of neuro-plasticity is error augmentation. In this paradigm the computer singles out and magnifies a stroke survivor's movement errors from a desired trajectory, thus forcing the subjects to strengthen their control. Using the VRROOM, a state-of-the-art system which uses haptics (robotic forces) and graphics (visual display) interfaces, a subject's desired trajectory can be determined and the movement errors can be amplified in real-time with dramatic results. This project evaluates a practical approach of error augmentation, using therapist-driven trajectories. The investigators intend to determine clinical efficacy of several types of therapist-assisted error augmentation on retraining the nervous system in functional activities. The investigators will test two experimental treatments in a crossover design. The investigators hypothesize that combined haptic and visual error augmentation will lead to the best functional recovery.

Condition or disease Intervention/treatment
Stroke Other: Error Augmentation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Error Augmentation for Neurorehabilitation
Study Start Date : January 2008
Primary Completion Date : March 2012
Study Completion Date : March 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: Error Augmentation-Control Other: Error Augmentation
error augmentation for arm motor recovery in individuals with stroke
Other Names:
  • Error Augmentation-Control
  • Control-Error Augmentation
Experimental: Control-Error Augmentation Other: Error Augmentation
error augmentation for arm motor recovery in individuals with stroke
Other Names:
  • Error Augmentation-Control
  • Control-Error Augmentation


Outcome Measures

Primary Outcome Measures :
  1. Arm motor recovery scores on the Fugl-Meyer [ Time Frame: Change from baseline in Fugl-Meyer to 11 weeks (with assessment periods occurring at 2 weeks, 3 weeks, 4 weeks, 6 weeks, 7 weeks, and 11 weeks for ARM 1; at start of week 1 (pre-eval), end of week 2 (post), and end of week 3 (1 week follow-up) for ARM 2) ]
    Change from baseline in arm motor recovery as measured by Fugl-Meyer


Secondary Outcome Measures :
  1. Number of blocks transferred in Box and Blocks Test [ Time Frame: same as primary ]
    Change from baseline in number of blocks transferred during Box and Blocks Test

  2. Time and Quality of movement scores on the Wolf Motor Function Test [ Time Frame: same as primary ]
    Change from baseline in arm motor recovery as measured by time scores and ability scores on the Wolf Motor Function test

  3. Time scores and Ability scores on the Assessment of Simple Functional Reach Test [ Time Frame: same as primary (not used for ARM 2) ]
    Change from baseline in arm motor recovery as measured by time scores and ability scores on the Assessment of Simple Functional Reach Test

  4. Quantity and Quality with Motor Activity Log [ Time Frame: same as primary but added for ARM 2 ]
    Change in baseline of self-reported quantity and quality of functional movements utilizing involved extremity


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult (age >18)
  • survived a single cortical stroke at least 6 months previously involving ischemia or hemorrhage of the middle cerebral artery (MCA),
  • demonstrated the presence of some active shoulder and elbow movement (characterized by Fugl-Meyer Assessment Upper Extremity scores ranging from 15-50 for ARM 1; 25-50 for ARM 2).

Exclusion Criteria:

  • diffuse or multiple lesion sites or multiple stroke events
  • bilateral paresis
  • severe spasticity or contracture (Modified Ashworth ≥3
  • severe concurrent medical problems
  • severe sensory deficits
  • cerebellar strokes resulting in severe ataxia
  • significant shoulder pain
  • focal tone management with Botulinim Toxin (Botox®) injection to the hemiparetic upper extremity (UE) within the previous four months,
  • aphasia that would influence the ability to perform the experiment
  • cognitive impairment (Mini Mental State Examination < 23/30)
  • affective dysfunction that would influence the ability to perform the experiment
  • depth perception impairment (< 3 on Stereo Circle Test)
  • visual field cut or hemispatial neglect that would influence the ability to participate in the activity
  • inability to provide informed consent
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01574495


Locations
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Shirley Ryan AbilityLab
U.S. Department of Education
Investigators
Principal Investigator: James Patton, PhD Shirley Ryan AbilityLab
More Information

Responsible Party: James Patton, Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01574495     History of Changes
Other Study ID Numbers: H133E0700 13
STU00002311 ( Other Identifier: NU IRB )
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by James Patton, Rehabilitation Institute of Chicago:
stroke
error augmentation
arm recovery
massed practice