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Evaluating Error Augmentation for Neurorehabilitation (VREA)

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
James Patton, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01574495
First received: February 28, 2012
Last updated: June 10, 2013
Last verified: June 2013

February 28, 2012
June 10, 2013
January 2008
March 2012   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Change from baseline in arm motor recovery as measured by Fugl-Meyer
Same as current
Complete list of historical versions of study NCT01574495 on ClinicalTrials.gov Archive Site
  • Number of blocks transferred in Box and Blocks Test [ Time Frame: same as primary ] [ Designated as safety issue: No ]
    Change from baseline in number of blocks transferred during Box and Blocks Test
  • Time and Quality of movement scores on the Wolf Motor Function Test [ Time Frame: same as primary ] [ Designated as safety issue: No ]
    Change from baseline in arm motor recovery as measured by time scores and ability scores on the Wolf Motor Function test
  • Time scores and Ability scores on the Assessment of Simple Functional Reach Test [ Time Frame: same as primary ] [ Designated as safety issue: No ]
    Change from baseline in arm motor recovery as measured by time scores and ability scores on the Assessment of Simple Functional Reach Test
Same as current
Not Provided
Not Provided
 
Evaluating Error Augmentation for Neurorehabilitation
Evaluating Error Augmentation for Neurorehabilitation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
Other: Error Augmentation
error augmentation for arm motor recovery in individuals with stroke
Other Names:
  • Error Augmentation-Control
  • Control-Error Augmentation
  • Experimental: Error Augmentation-Control
    Intervention: Other: Error Augmentation
  • Experimental: Control-Error Augmentation
    Intervention: Other: Error Augmentation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2012
March 2012   (final data collection date for primary outcome measure)

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).

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01574495
H133E0700 13, STU00002311
No
James Patton, Rehabilitation Institute of Chicago
Rehabilitation Institute of Chicago
U.S. Department of Education
Principal Investigator: James Patton, PhD Rehabilitation Institute of Chicago
Rehabilitation Institute of Chicago
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP