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Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662960
First Posted: August 13, 2012
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steve Jax, Albert Einstein Healthcare Network
  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: Triple (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 Steve Jax, 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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Submitted: August 8, 2012
First Posted: August 13, 2012
Last Update Posted: April 4, 2017
Last Verified: April 2017

Keywords provided by Steve Jax, 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