Facilitating Implicit Learning to Improve Neurorehabilitation in Stroke

NCT02017574 | Completed Results

• 1 other identifier: N0970-M
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is one of the leading causes of chronic disability in Veterans. Stroke is associated with significant loss of mobility, increased risk of falling, cardiovascular disease, depression and neuro-cognitive impairment. These deficits negatively impact the independent completion of the Activities of Daily Living (ADLs). Task-oriented training has emerged as the dominant therapeutic intervention in the rehabilitation of chronic stroke victims. The effectiveness of these interventions may be enhanced through facilitation of implicit knowledge rather than explicit knowledge. Specifically, implicit learning increases retention and improves transfer of the improved motor function outside of the lab environment. Moreover, implicit motor control reduces the burden imposed on cognitive resources as the skill is performed automatically (i.e. do not have to 'think' about it). The amount and type of feedback individuals receive while learning a new task (or relearning in the case of rehabilitation) has been shown to influence the type of learning (i.e. implicit or explicit). Thus the purpose of the current study is to determine the effect of different types of feedback during motor learning on the learning type and the resultant impact on functional outcomes (i.e. motor performance, retention, and cognitive workload) in chronic stroke patients.

Conditions

Cerebral Stroke

Keywords

Stroke; Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

• Quality of Motor Performance

  Quality of motor behavior was indexed by the percentage of samples in which the participants were within the trained (i.e. optimal) trajectory. The trained trajectory was a 2cm wide channel in the shape of a half circle between two targets which were 25cm apart from each other. Therefore, the scale measure is a percentage which can range between 0 and 100%.

  2 Years

Secondary Outcomes (1)

• EEG Derived High Alpha Power

  2 Years

Study Arms (2)

Implicit Group

EXPERIMENTAL

Receives little feedback about task performance during learning

Behavioral: Reaching Task

Control

ACTIVE COMPARATOR

Receives detailed feedback about task performance during learning

Behavioral: Reaching Task

Interventions

Reaching Task BEHAVIORAL

Learn a reaching task that requires coordination of the arm segments

Control; Implicit Group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic stroke greater than 3 months prior.
• Between 45 and 80 years of age.
• Residual hemiparetic upper extremity deficits.
• Adequate language and neurocognitive function to participate in training (MMSE, CESD, aphasia screening).
• Right hand dominant.
• Upper Extremity Fugl-Meyer score of 25 or greater.

You may not qualify if:

• History of cortical stroke.
• No mobility of less affected arm.
• Failure to meet the RRDC assessment clinic criteria for medical eligibility.
• MMSE score less than 27.
• CES-D score greater than 16.
• Unable to pass a hearing test (i.e. must be able to hear sounds of 45 dB or less).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Stroke; Cerebral Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Jeremy Rietschel, PhD
• Organization: Baltimore Veterans Affairs

jeremy.rietschel@va.gov

410-605-7000

Study Officials

• Jeremy C Rietschel, PhD MA BA

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2016
• Last Updated: March 28, 2017
• Results First Posted: February 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)