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Completed

NCT Number: NCT01662960

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.

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Key information

Conditions

Hemiparesis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Einstein Medical Center Elkins Park

Elkins Park, Pennsylvania, 19027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirror Therapy

Behavioral

A home-based therapy involving mirrored visual feedback

Divider therapy

Behavioral

A home-based therapy involving removed visual feedback.

Primary outcomes

  1. Upper Extremity Fugl-Meyer

    Time frame: Immediately after 1 month of treatment

    This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.

  2. Action Research Arm Test

    Time frame: 1 month

    The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.

  3. Rivermead Assessment of Somatosensory Performance

    Time frame: 1 month

    This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.

  4. Virtual-reality Assessment of Navigation

    Time frame: 1 month

    This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.

Secondary outcomes

  1. Stroke Impact Scale

    Time frame: 1 month

    This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.

  2. Wolf Motor Function Test

    Time frame: 1 months

    The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.

Sponsors and collaborators

Lead sponsor

Albert Einstein Healthcare Network

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Aug 13, 2012
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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