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

NCT03141996 | Terminated

• 1 other identifier: NEGLECT STUDY
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Spatial Neglect

Keywords

vibration; stroke; activities of daily living

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Behavioral Inattention test

  Day 30

• Behavioral Inattention test

  Day 60

• Catherine Bergego Scale (CBS)

  Day 0

• Catherine Bergego Scale (CBS)

  Day 30

• Catherine Bergego Scale (CBS)

  Day 90

Study Arms (2)

Vibration to upper posterior neck muscles

EXPERIMENTAL

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

Standard of care

ACTIVE COMPARATOR

Regular occupational therapy session

Other: Standard of Care

Interventions

Vibration to upper posterior neck muscles OTHER

Vibration to upper posterior neck muscles using a vibrational tool.

Also known as: Magic Wand Massager

Vibration to upper posterior neck muscles

Standard of Care OTHER

Standard of care treatment

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• severe pain or skin disease at the posterior neck
• severe atherosclerosis of carotid arteries by an ultrasonic evaluation

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Related Publications (1)

• 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.

  PMID: 34196963 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Florentina Mueller-Planitz

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 5, 2017
• Study Start: April 16, 2017
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)