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Evaluating Error Augmentation for Neurorehabilitation (VREA)

Shirley Ryan AbilityLab logo

Shirley Ryan AbilityLab

Status

Completed

Conditions

Stroke

Treatments

Other: Error Augmentation

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01574495
STU00002311 (Other Identifier)
H133E0700 13

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

40 participants in 2 patient groups

Error Augmentation-Control
Experimental group
Treatment:
Other: Error Augmentation
Control-Error Augmentation
Experimental group
Treatment:
Other: Error Augmentation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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