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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Unilateral Spatial Neglect

Intervention / Treatment
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* Other: Vibration to upper posterior neck muscles
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibration to upper posterior neck muscles<br>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<br>* Vibration to upper posterior neck muscles using a vibrational tool.<br>* Other names: Magic Wand Massager;|
| Active Comparator: Standard of care<br>Regular occupational therapy session | Other: Standard of Care<br>* Standard of care treatment<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vibration, stroke, activities of daily living