Evaluating Error Augmentation for Neurorehabilitation

NCT ID: NCT01574495

Last Updated: 2015-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-03-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Error Augmentation-Control

Group Type: EXPERIMENTAL

Error Augmentation

Intervention Type: OTHER

error augmentation for arm motor recovery in individuals with stroke

Control-Error Augmentation

Group Type: EXPERIMENTAL

Error Augmentation

Intervention Type: OTHER

error augmentation for arm motor recovery in individuals with stroke

Interventions

Error Augmentation

error augmentation for arm motor recovery in individuals with stroke

Intervention Type: OTHER

Other Intervention Names

Error Augmentation-Control; Control-Error Augmentation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Department of Education

FED

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

James Patton

Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Patton, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00002311

Identifier Type: OTHER

Identifier Source: secondary_id

H133E0700 13

Identifier Type: -

Identifier Source: org_study_id