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Facilitating Implicit Learning to Improve Neurorehabilitation in Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02017574
First received: December 16, 2013
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Cerebral Stroke
Behavioral: Reaching Task

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Basic Science
Official Title: Facilitating Implicit Learning to Improve Neurorehabilitation in Stroke

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Quality of Motor Performance [ Time Frame: 2 Years ]
    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%.


Secondary Outcome Measures:
  • EEG Derived High Alpha Power [ Time Frame: 2 Years ]
    Brain electrophysiology measure of attentional processes as indexed by high alpha power (10-13 Hz). The unit of measurement is a percentage as the amount of power (microvolts squared) in the high alpha band was divided by the total power in the spectrum (i.e. 1-50 Hz). This method is commonly employed to normalize the power of a particular frequency if the statistical design includes a between subjects factor.


Enrollment: 24
Study Start Date: October 2013
Study Completion Date: September 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implicit Group
Receives little feedback about task performance during learning
Behavioral: Reaching Task
Learn a reaching task that requires coordination of the arm segments
Active Comparator: Control
Receives detailed feedback about task performance during learning
Behavioral: Reaching Task
Learn a reaching task that requires coordination of the arm segments

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017574

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Jeremy C Rietschel, PhD MA BA Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02017574     History of Changes
Other Study ID Numbers: N0970-M
Study First Received: December 16, 2013
Results First Received: October 17, 2016
Last Updated: February 23, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
Stroke
Cerebral Infarction

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 28, 2017