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Completed

NCT Number: NCT01574495

Evaluating Error Augmentation for Neurorehabilitation

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Error Augmentation

Other

error augmentation for arm motor recovery in individuals with stroke

Other names: Error Augmentation-Control, Control-Error Augmentation

Primary outcomes

  1. Arm motor recovery scores on the 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)

    Change from baseline in arm motor recovery as measured by Fugl-Meyer

Secondary outcomes

  1. Number of blocks transferred in Box and Blocks Test

    Time frame: same as primary

    Change from baseline in number of blocks transferred during Box and Blocks Test

  2. Time and Quality of movement scores on the Wolf Motor Function Test

    Time frame: same as primary

    Change from baseline in arm motor recovery as measured by time scores and ability scores on the Wolf Motor Function test

  3. Time scores and Ability scores on the Assessment of Simple Functional Reach Test

    Time frame: same 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

  4. Quantity and Quality with Motor Activity Log

    Time frame: same as primary but added for ARM 2

    Change in baseline of self-reported quantity and quality of functional movements utilizing involved extremity

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • U.S. Department of Education

Registry information

Acronym: VREA

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 10, 2012
Registry last updated
Sep 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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