Evaluating Error Augmentation for Neurorehabilitation (VREA)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Error Augmentation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Rehabilitation Institute of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Error Augmentation-Control	Other: Error Augmentation; error augmentation for arm motor recovery in individuals with stroke; Other Names: Error Augmentation-Control; Control-Error Augmentation
Experimental: Control-Error Augmentation	Other: Error Augmentation; error augmentation for arm motor recovery in individuals with stroke; Other Names: Error Augmentation-Control; Control-Error Augmentation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Collaborators: U.S. Department of Education
• Investigators: Principal Investigator: James Patton, PhD, Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 28, 2012
• First Submitted That Met QC Criteria: April 8, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): September 24, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: stroke; massed practice; error augmentation; arm recovery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: H133E0700 13; STU00002311 (Other Identifier: NU IRB)