Back to resultsEvaluating Error Augmentation for Neurorehabilitation (VREA)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Error Augmentation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, error augmentation, arm recovery, massed practice
Eligibility 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
Sites / Locations
- Rehabilitation Institute of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Error Augmentation-Control
Control-Error Augmentation
Arm Description
Outcomes
Primary Outcome Measures
Arm motor recovery scores on the Fugl-Meyer
Change from baseline in arm motor recovery as measured by Fugl-Meyer
Secondary Outcome Measures
Number of blocks transferred in Box and Blocks Test
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
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
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
Change in baseline of self-reported quantity and quality of functional movements utilizing involved extremity
Full Information
NCT ID
NCT01574495
First Posted
February 28, 2012
Last Updated
September 23, 2015
Sponsor
Shirley Ryan AbilityLab
Collaborators
U.S. Department of Education
1. Study Identification
Unique Protocol Identification Number
NCT01574495
Brief Title
Evaluating Error Augmentation for Neurorehabilitation
Acronym
VREA
Official Title
Evaluating Error Augmentation for Neurorehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
U.S. Department of Education
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, error augmentation, arm recovery, massed practice
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Error Augmentation-Control
Arm Type
Experimental
Arm Title
Control-Error Augmentation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Error Augmentation
Other Intervention Name(s)
Error Augmentation-Control, Control-Error Augmentation
Intervention Description
error augmentation for arm motor recovery in individuals with stroke
Primary Outcome Measure Information:
Title
Arm motor recovery scores on the Fugl-Meyer
Description
Change from baseline in arm motor recovery as measured by 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)
Secondary Outcome Measure Information:
Title
Number of blocks transferred in Box and Blocks Test
Description
Change from baseline in number of blocks transferred during Box and Blocks Test
Time Frame
same as primary
Title
Time and Quality of movement scores on the Wolf Motor Function Test
Description
Change from baseline in arm motor recovery as measured by time scores and ability scores on the Wolf Motor Function test
Time Frame
same as primary
Title
Time scores and Ability scores on the Assessment of Simple Functional Reach Test
Description
Change from baseline in arm motor recovery as measured by time scores and ability scores on the Assessment of Simple Functional Reach Test
Time Frame
same as primary (not used for ARM 2)
Title
Quantity and Quality with Motor Activity Log
Description
Change in baseline of self-reported quantity and quality of functional movements utilizing involved extremity
Time Frame
same as primary but added for ARM 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Patton, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating Error Augmentation for Neurorehabilitation
We'll reach out to this number within 24 hrs