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Evaluating Error Augmentation for Neurorehabilitation (VREA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01574495
First Posted: April 10, 2012
Last Update Posted: September 24, 2015
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.
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
James Patton, Rehabilitation Institute of Chicago
February 28, 2012
April 10, 2012
September 24, 2015
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 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
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) ]
Change from baseline in arm motor recovery as measured by Fugl-Meyer
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 ]
    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 ]
    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 (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
  • 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
  • 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
  • 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
  • Time scores and Ability scores on the Assessment of Simple Functional Reach Test [ Time Frame: same as primary ]
    Change from baseline in arm motor recovery as measured by time scores and ability scores on the Assessment of Simple Functional Reach Test
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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01574495
H133E0700 13
STU00002311 ( Other Identifier: NU IRB )
No
Not Provided
Not Provided
James Patton, Rehabilitation Institute of Chicago
Shirley Ryan AbilityLab
U.S. Department of Education
Principal Investigator: James Patton, PhD Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
September 2015

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