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Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steve Jax, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:
NCT01662960
First received: August 8, 2012
Last updated: April 3, 2017
Last verified: April 2017
  Purpose
The purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.

Condition Intervention
Hemiparesis
Stroke
Behavioral: Visual feedback therapy #1
Behavioral: Visual feedback therapy #2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

Further study details as provided by Albert Einstein Healthcare Network:

Primary Outcome Measures:
  • Fugl-Meyer [ Time Frame: 1 month ]
    This test measures impairment-level ability to move the arm.

  • Action Research Arm Test [ Time Frame: 1 month ]
    The test measures the ability and speed to completed simulated everyday tasks with the arm.

  • Rivermead Assessment of Somatosensory Performance [ Time Frame: 1 month ]
    This test measures the integrity of sensory perception of the arm.

  • Virtual-reality assessment of navigation [ Time Frame: 1 month ]
    This test measures the ability to detect attention problems in a simulated navigation test.


Secondary Outcome Measures:
  • Stroke Impact Scale [ Time Frame: 1 month ]
    This test measure the self-reported ability to complete everyday tasks with the arm.

  • Wolf motor function test [ Time Frame: 1 months ]
    The test measures the ability and speed to completed simulated everyday tasks with the arm.


Enrollment: 72
Actual Study Start Date: September 7, 2012
Study Completion Date: February 27, 2017
Primary Completion Date: February 27, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Visual feedback therapy #1
In both forms of visual feedback therapy, participants will practice making movements at home without full visual feedback of their low-functioning arm.
Behavioral: Visual feedback therapy #1
A home based therapy involving modification of visual feedback.
Active Comparator: Visual feedback therapy #2
In both forms of visual feedback therapy, participants will practice making movements at home without full visual feedback of their low-functioning arm.
Behavioral: Visual feedback therapy #2
A home based therapy involving modification of visual feedback.

Detailed Description:
This study will compare two forms of home-based treatment for post-stroke problems making movements with the arms and hands. After initial pre-treatment assessments, participants will complete 4 weeks of treatment, with assessments after each week of treatment and 3 months after the completion of treatment.
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 months or more post-stroke
  • upper extremity Fugl-Meyer score between 10 and 50
  • no longer participating in upper-extremity physical or occupational therapy
  • sufficient comprehension ability to understand instructions

Exclusion Criteria:

  • previous head trauma, psychiatric illness or chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g., haloperidol, dopaminergics)
  • dementia
  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: NCT01662960

Locations
United States, Pennsylvania
Einstein Medical Center Elkins Park
Elkins Park, Pennsylvania, United States, 19027
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
Principal Investigator: Steven Jax, Ph. D. Albert Einstein Healthcare Network
  More Information

Responsible Party: Steve Jax, Institute Scientist, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT01662960     History of Changes
Other Study ID Numbers: HN 4404
NIH R01 HD068565 ( Other Identifier: Einstein Healthcare Network )
Study First Received: August 8, 2012
Last Updated: April 3, 2017

Keywords provided by Albert Einstein Healthcare Network:
stroke
hemiparesis
arm movement
sensory functioning

Additional relevant MeSH terms:
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 28, 2017