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

August 8, 2012
April 4, 2014
July 2012
July 2017   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01662960 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Hemiparesis
  • Stroke
  • Behavioral: Visual feedback therapy #1
    A home based therapy involving modification of visual feedback.
  • Behavioral: Visual feedback therapy #2
    A home based therapy involving modification of visual feedback.
  • 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.
    Intervention: Behavioral: Visual feedback therapy #1
  • 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.
    Intervention: Behavioral: Visual feedback therapy #2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
July 2017
July 2017   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01662960
NIH R01 HD068565, HN 4404
No
Steve Jax, Albert Einstein Healthcare Network
Albert Einstein Healthcare Network
Not Provided
Principal Investigator: Steven Jax, Ph. D. Albert Einstein Healthcare Network
Albert Einstein Healthcare Network
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP