Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Steve Jax, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:
NCT01662960
First received: August 8, 2012
Last updated: April 4, 2014
Last verified: April 2014
  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: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

Resource links provided by NLM:


Further study details as provided by Albert Einstein Healthcare Network:

Primary Outcome Measures:
  • Fugl-Meyer [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    This test measures impairment-level ability to move the arm.

  • Action Research Arm Test [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The test measures the ability and speed to completed simulated everyday tasks with the arm.

  • Rivermead Assessment of Somatosensory Performance [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    This test measures the integrity of sensory perception of the arm.

  • Virtual-reality assessment of navigation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    This test measures the ability to detect attention problems in a simulated navigation test.


Secondary Outcome Measures:
  • Stroke Impact Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    This test measure the self-reported ability to complete everyday tasks with the arm.

  • Wolf motor function test [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    The test measures the ability and speed to completed simulated everyday tasks with the arm.


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 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
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Steve Jax, Institute Scientist, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT01662960     History of Changes
Other Study ID Numbers: NIH R01 HD068565, HN 4404
Study First Received: August 8, 2012
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014