Evaluating Error Augmentation for Neurorehabilitation (VREA)

• ClinicalTrials.gov Identifier: NCT01574495
• Recruitment Status: Completed
• First Posted: April 10, 2012
• Last Update Posted: September 24, 2015
• Sponsor: Shirley Ryan AbilityLab
• Collaborator: U.S. Department of Education
• Information provided by (Responsible Party): James Patton, Shirley Ryan AbilityLab

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Other: Error Augmentation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluating Error Augmentation for Neurorehabilitation
• Study Start Date: January 2008
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Illinois

Rehabilitation Institute of Chicago

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Shirley Ryan AbilityLab

U.S. Department of Education

Investigators

• Principal Investigator: James Patton, PhD; Shirley Ryan AbilityLab

More Information

• Responsible Party: James Patton, Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago, Shirley Ryan AbilityLab
• ClinicalTrials.gov Identifier: NCT01574495
• Other Study ID Numbers: H133E0700 13; STU00002311 ( Other Identifier: NU IRB )
• First Posted: April 10, 2012
• Last Update Posted: September 24, 2015
• Last Verified: September 2015

Keywords provided by James Patton, Shirley Ryan AbilityLab:

stroke; error augmentation; arm recovery; massed practice

Additional relevant MeSH terms:

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