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Evaluating Error Augmentation for Neurorehabilitation

Evaluating Error Augmentation for Neurorehabilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01574495
Acronym
VREA
Enrollment
40
Registered
2012-04-10
Start date
2008-01-31
Completion date
2012-03-31
Last updated
2015-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, error augmentation, arm recovery, massed practice

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.

Interventions

error augmentation for arm motor recovery in individuals with stroke

Sponsors

U.S. Department of Education
CollaboratorFED
Shirley Ryan AbilityLab
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Arm motor recovery scores on the Fugl-MeyerChange 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

MeasureTime frameDescription
Number of blocks transferred in Box and Blocks Testsame as primaryChange from baseline in number of blocks transferred during Box and Blocks Test
Time and Quality of movement scores on the Wolf Motor Function Testsame as primaryChange 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 Testsame 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 Logsame as primary but added for ARM 2Change in baseline of self-reported quantity and quality of functional movements utilizing involved extremity

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026