Clinical trial NCT01574495: Evaluating Error Augmentation for Neurorehabilitation
Official title: Evaluating Error Augmentation for Neurorehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
error augmentation
arm recovery
massed practice
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2012-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Arm motor recovery scores on the Fugl-Meyer
timeFrame: 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 outcomes:
measure: Number of blocks transferred in Box and Blocks Test
timeFrame: same as primary
measure: Time and Quality of movement scores on the Wolf Motor Function Test
timeFrame: same as primary
measure: Time scores and Ability scores on the Assessment of Simple Functional Reach Test
timeFrame: same as primary (not used for ARM 2)
measure: Quantity and Quality with Motor Activity Log
timeFrame: same as primary but added for ARM 2
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: James Patton, PhD
role: PRINCIPAL_INVESTIGATOR
References: