Evaluating Error Augmentation for Neurorehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating Error Augmentation for Neurorehabilitation

Conditions
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Stroke

Intervention / Treatment
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* Other: Error Augmentation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Error Augmentation-Control<br> | Other: Error Augmentation<br>* error augmentation for arm motor recovery in individuals with stroke<br>* Other names: Control-Error Augmentation;|
| Experimental: Control-Error Augmentation<br> | Other: Error Augmentation<br>* error augmentation for arm motor recovery in individuals with stroke<br>* Other names: Control-Error Augmentation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm motor recovery scores on the Fugl-Meyer | Change from baseline in arm motor recovery as measured by Fugl-Meyer | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blocks transferred in Box and Blocks Test | Change from baseline in number of blocks transferred during Box and Blocks Test | same as primary | 
| 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 | same as primary | 
| 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 | same as primary (not used for ARM 2) | 
| Quantity and Quality with Motor Activity Log | Change in baseline of self-reported quantity and quality of functional movements utilizing involved extremity | same as primary but added for ARM 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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error augmentation, massed practice, stroke, arm recovery