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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke | Other: Error Augmentation | Not Applicable |
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 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | March 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Error Augmentation-Control |
Other: Error Augmentation
error augmentation for arm motor recovery in individuals with stroke
Other Names:
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Experimental: Control-Error Augmentation |
Other: Error Augmentation
error augmentation for arm motor recovery in individuals with stroke
Other Names:
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- 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
- 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

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

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
United States, Illinois | |
Rehabilitation Institute of Chicago | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | James Patton, PhD | Shirley Ryan AbilityLab |
Responsible Party: | James Patton, Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago, Shirley Ryan AbilityLab |
ClinicalTrials.gov Identifier: | NCT01574495 |
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 |
stroke error augmentation arm recovery massed practice |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |