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

NCT ID: NCT03141996

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-16

Study Completion Date

2018-04-12

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.

Conditions

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Unilateral Spatial Neglect

Keywords

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vibration stroke activities of daily living

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Vibration to upper posterior neck muscles

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

Group Type EXPERIMENTAL

Vibration to upper posterior neck muscles

Intervention Type OTHER

Vibration to upper posterior neck muscles using a vibrational tool.

Standard of care

Regular occupational therapy session

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Standard of care treatment

Interventions

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Vibration to upper posterior neck muscles

Vibration to upper posterior neck muscles using a vibrational tool.

Intervention Type OTHER

Standard of Care

Standard of care treatment

Intervention Type OTHER

Other Intervention Names

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Magic Wand Massager

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intermountain Health Care, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florentina Mueller-Planitz

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Locations

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Intermountain Medical Center

Murray, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34196963 (View on PubMed)

Other Identifiers

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NEGLECT STUDY

Identifier Type: -

Identifier Source: org_study_id