Prism Adaptation Training for Treatment of Spatial Neglect During Inpatient Rehabilitation

July 14, 2021 updated by: Robert Gillen, Sunnyview Rehabilitation Hospital

Left sided spatial neglect is a common yet potentially debilitating phenomena associated with right hemisphere stroke. Heilman defines neglect as "the failure to report, respond, or orient to novel or meaningful stimuli presented to the side opposite of a brain lesion that cannot be attributed to either sensory or motor deficits". Numerous studies have demonstrated the impact of spatial neglect in right hemisphere stroke patients on both rehabilitation outcomes, and subsequent functioning in the community. Given the highly significant negative impact of spatial neglect, numerous treatment approaches have been attempted, yet most lack evidence in terms of efficacy. One promising exception has been prism adaptation training (PAT), which several recent reviews reported improved independence as a benefit of this treatment, both in terms of ameliorating the severity of neglect and demonstrating generalization to important functional behaviors. Still, much remains unknown regarding PAT, and not all studies have shown positive results.

At Sunnyview Rehabilitation Hospital, a number of providers have added PAT to the standard PT, OT and speech that stroke patients receive during their inpatient stay. As part of a process improvement initiative the investigators identified 57 patients that received PAT training between June 2016 and September of 2019. The investigators propose a retrospective case-control study examining the impact of PAT treatment on the rehabilitation outcomes for these patients. Outcome variables to be assessed include the measures of spatial neglect (Catherine Bergego Scale), functional independence measures (FIM), length of hospitalization and discharge destination. The investigators hypothesize that patients who received 4 or more PAT sessions during their inpatient rehabilitation stay will show improvements both in measures of neglect and functional independence as a result of this treatment.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

74

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatient Rehabilitation Facility (IRF)

Description

Inclusion Criteria:

  • Right hemisphere stroke
  • Admitted between 6/2016 & 12/2019

Exclusion Criteria:

  • Absence of neglect
  • Incomplete Catherine Bergego Scale (Less than 7 items scored)
  • Evidence of traumatic brain injury
  • Brain cancer
  • Dementia
  • Parkinson's disease
  • Alzheimer's disease
  • aphasia
  • Interrupted hospital admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prism Adaptation Training;
Patients who received prism adaptation training for treatment of spatial neglect during their inpatient rehabilitation admission
Therapists administering PAT followed the protocol developed by the Kessler Foundation (2014).PAT sessions lasted approximately 30 minutes during which patients with left sided neglect don 20 diopter prism goggles deviating their visual field to the right while aiming their finger at a series of visual targets.
Standard Care
Patients who received standard treatment of spatial neglect during their admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catherine Bergego Scale
Time Frame: Up to 55 days
Behavioral measure of unilateral spatial neglect. Scored 0-30. Higher numbers indicate greater severity of spatial neglect.
Up to 55 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Independence Measure (FIM)
Time Frame: Up to 55 days
Measure of motoric and behavioral functioning of patients (eating, toileting, dressing, mobility). Scores range from 18-126. Higher scores indicate greater functional independence.
Up to 55 days
Length of Stay
Time Frame: Up to 55 days
Length of inpatient hospital admission
Up to 55 days
Discharge destination
Time Frame: Up to 55 days
Destination of patient following discharge: Home, Subacute nursing facility, Acute care hospital
Up to 55 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 26, 2021

Study Record Updates

Last Update Posted (Actual)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 21-0505-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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