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

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.

Study Overview

• Status: Terminated
• Conditions: Unilateral Spatial Neglect
• Intervention / Treatment: Other: Vibration to upper posterior neck muscles; Other: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84157
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Magic Wand Massager
ACTIVE_COMPARATOR: Standard of care; Regular occupational therapy session	Other: Standard of Care; Standard of care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 30
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	Day 60
Catherine Bergego Scale (CBS)	a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.	Day 0
Catherine Bergego Scale (CBS)	a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.	Day 30
Catherine Bergego Scale (CBS)	a standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations.	Day 90
Activity Measure for Post-Acute Care (AM-PAC)	AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.	Day 0
Activity Measure for Post-Acute Care (AM-PAC)	AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.	Day 30
Activity Measure for Post-Acute Care (AM-PAC)	AM-PAC measures patients' capabilities in functional areas for prioritization of therapy resources.	Day 60

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Florentina Mueller-Planitz, Intermountain Health Care, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 16, 2017
• Primary Completion (ACTUAL): April 12, 2018
• Study Completion (ACTUAL): April 12, 2018

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (ACTUAL): May 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: stroke; activities of daily living; vibration
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders
• Other Study ID Numbers: NEGLECT STUDY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No