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

Not Applicable

Terminated

• Conditions: Unilateral Spatial Neglect
• Interventions: Other: Vibration to upper posterior neck muscles; Other: Standard of Care

• Registration Number: NCT03141996
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-04-16
• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Primary Completion: 2018-04-12
• Study Completion: 2018-04-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibration to upper posterior neck muscles	Vibration to upper posterior neck muscles	Treatment will be performed by occupational therapist practitioners prior to regular occupational therapy session using a vibration tool.
Standard of care	Standard of Care	Regular occupational therapy session

Primary Outcome Measures

Name	Time	Method
Behavioral Inattention test	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

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

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States