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

Primary Purpose

Unilateral Spatial Neglect

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibration to upper posterior neck muscles
Standard of Care
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Unilateral Spatial Neglect focused on measuring vibration, stroke, activities of daily living

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intermountain Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vibration to upper posterior neck muscles

Standard of care

Arm Description

Treatment will be performed by occupational therapist practitioners prior to regular occupational therapy session using a vibration tool.

Regular occupational therapy session

Outcomes

Primary Outcome Measures

Behavioral Inattention test
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

Behavioral Inattention test
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
Behavioral Inattention test
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
Catherine Bergego Scale (CBS)
a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.
Catherine Bergego Scale (CBS)
a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.
Catherine Bergego Scale (CBS)
a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.
Activity Measure for Post-Acute Care (AM-PAC)
AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.
Activity Measure for Post-Acute Care (AM-PAC)
AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.
Activity Measure for Post-Acute Care (AM-PAC)
AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.

Full Information

First Posted
May 3, 2017
Last Updated
November 28, 2018
Sponsor
Intermountain Health Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03141996
Brief Title
Use of Vibration to Improve Visual/Spatial Neglect in Patients Affected by Stroke
Acronym
NEGLECT
Official Title
Use of Vibration to Improve Visual/Spatial Neglect in Patients Affected by Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
April 16, 2017 (Actual)
Primary Completion Date
April 12, 2018 (Actual)
Study Completion Date
April 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Spatial Neglect
Keywords
vibration, stroke, activities of daily living

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vibration to upper posterior neck muscles
Arm Type
Experimental
Arm Description
Treatment will be performed by occupational therapist practitioners prior to regular occupational therapy session using a vibration tool.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Regular occupational therapy session
Intervention Type
Other
Intervention Name(s)
Vibration to upper posterior neck muscles
Other Intervention Name(s)
Magic Wand Massager
Intervention Description
Vibration to upper posterior neck muscles using a vibrational tool.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care treatment
Primary Outcome Measure Information:
Title
Behavioral Inattention test
Description
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
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Behavioral Inattention test
Description
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
Time Frame
Day 30
Title
Behavioral Inattention test
Description
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
Time Frame
Day 60
Title
Catherine Bergego Scale (CBS)
Description
a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.
Time Frame
Day 0
Title
Catherine Bergego Scale (CBS)
Description
a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.
Time Frame
Day 30
Title
Catherine Bergego Scale (CBS)
Description
a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.
Time Frame
Day 90
Title
Activity Measure for Post-Acute Care (AM-PAC)
Description
AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.
Time Frame
Day 0
Title
Activity Measure for Post-Acute Care (AM-PAC)
Description
AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.
Time Frame
Day 30
Title
Activity Measure for Post-Acute Care (AM-PAC)
Description
AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.
Time Frame
Day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florentina Mueller-Planitz
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34196963
Citation
Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
Results Reference
derived

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

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