Evaluating Error Augmentation for Neurorehabilitation

Stroke Clinical Trial

— VREA  

Official title:

Evaluating Error Augmentation for Neurorehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574495
• Other study ID #: H133E0700 13
• Secondary ID: STU00002311
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: September 23, 2015
• Start date: January 2008
• Est. completion date: March 2012

Study information

• Verified date: September 2015
• Source: Rehabilitation Institute of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Error Augmentation
error augmentation for arm motor recovery in individuals with stroke

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rehabilitation Institute of Chicago	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No