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Use of Vibration to Improve Visual/Spatial Neglect in Patients Affected by Stroke (NEGLECT)

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ClinicalTrials.gov Identifier: NCT03141996
Recruitment Status : Terminated (Poor enrollment)
First Posted : May 5, 2017
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

Brief Summary:
This study will measure if five minutes of vibration to the upper back neck muscles, prior to standard of care treatment, will improve symptoms of spatial neglect and/or activities of daily living function for patients who have had a stroke.

Condition or disease Intervention/treatment Phase
Unilateral Spatial Neglect Other: Vibration to upper posterior neck muscles Other: Standard of Care Not Applicable

Detailed Description:
Spatial neglect is a common syndrome following stroke, most frequently of the right side of the brain. Such patients fail to be aware of objects or people to their left. This study is being done to learn if vibration treatment can improve visual/spatial neglect and activities of daily living in stroke patients better than current standard intervention.This treatment will be performed by occupational therapist practitioners prior to regular occupational therapy session using a vibration tool.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of Vibration to Improve Visual/Spatial Neglect in Patients Affected by Stroke
Actual Study Start Date : April 16, 2017
Actual Primary Completion Date : April 12, 2018
Actual Study Completion Date : April 12, 2018

Arm Intervention/treatment
Experimental: Vibration to upper posterior neck muscles
Treatment will be performed by occupational therapist practitioners prior to regular occupational therapy session using a vibration tool.
Other: Vibration to upper posterior neck muscles
Vibration to upper posterior neck muscles using a vibrational tool.
Other Name: Magic Wand Massager

Active Comparator: Standard of care
Regular occupational therapy session
Other: Standard of Care
Standard of care treatment




Primary Outcome Measures :
  1. Behavioral Inattention test [ Time Frame: Day 0 ]
    A short screening battery of tests to assess the presence and the extent of visual neglect on a sample of everyday problems faced by patients


Secondary Outcome Measures :
  1. Behavioral Inattention test [ Time Frame: Day 30 ]
    A short screening battery of tests to assess the presence and the extent of visual neglect on a sample of everyday problems faced by patients

  2. Behavioral Inattention test [ Time Frame: Day 60 ]
    A short screening battery of tests to assess the presence and the extent of visual neglect on a sample of everyday problems faced by patients

  3. Catherine Bergego Scale (CBS) [ Time Frame: Day 0 ]
    a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.

  4. Catherine Bergego Scale (CBS) [ Time Frame: Day 30 ]
    a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.

  5. Catherine Bergego Scale (CBS) [ Time Frame: Day 90 ]
    a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.

  6. Activity Measure for Post-Acute Care (AM-PAC) [ Time Frame: Day 0 ]
    AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.

  7. Activity Measure for Post-Acute Care (AM-PAC) [ Time Frame: Day 30 ]
    AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.

  8. Activity Measure for Post-Acute Care (AM-PAC) [ Time Frame: Day 60 ]
    AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old or older
  • demonstrated visual/spatial neglect, as demonstrated by NIH Stroke Scale (NIHSS) and deficits in assessing tactile extinction and visuospatial neglect done on admission.

Exclusion Criteria:

  • severe pain or skin disease at the posterior neck
  • severe atherosclerosis of carotid arteries by an ultrasonic evaluation

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): NCT03141996


Locations
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United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
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Principal Investigator: Florentina Mueller-Planitz Intermountain Health Care, Inc.
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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT03141996    
Other Study ID Numbers: NEGLECT STUDY
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intermountain Health Care, Inc.:
vibration
stroke
activities of daily living
Additional relevant MeSH terms:
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Perceptual Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations