Evaluating Error Augmentation for Neurorehabilitation

NCT01574495 | Completed

• 2 other identifiers: H133E0700 13STU00002311
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; error augmentation; arm recovery; massed practice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of blocks transferred in Box and Blocks Test

  same as primary

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

  same as primary

• 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

  same as primary but added for ARM 2

Study Arms (2)

Error Augmentation-Control

EXPERIMENTAL

Other: Error Augmentation

Control-Error Augmentation

EXPERIMENTAL

Other: Error Augmentation

Interventions

Error Augmentation OTHER

error augmentation for arm motor recovery in individuals with stroke

Also known as: Error Augmentation-Control, Control-Error Augmentation

Control-Error Augmentation; Error Augmentation-Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• James Patton, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: April 10, 2012
• Study Start: January 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

US (1)