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

Unilateral Spatial Neglect Clinical Trial

— NEGLECT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03141996
• Other study ID #: NEGLECT STUDY
• Status: Terminated
• Phase: N/A
• Start date: April 16, 2017
• Est. completion date: April 12, 2018

Study information

• Verified date: November 2018
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 12, 2018
• Est. primary completion date: April 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perceptual Disorders
• Unilateral Spatial Neglect

Intervention

Other:
• Vibration to upper posterior neck muscles
Vibration to upper posterior neck muscles using a vibrational tool.
• Standard of Care
Standard of care treatment

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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