- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04977219
Prism Adaptation Training for Treatment of Spatial Neglect During Inpatient Rehabilitation
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
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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Clinical Trials on Prism Adaptation Training
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VA Office of Research and DevelopmentCompleted
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Kessler FoundationCompletedStroke | Aphasia | Spatial NeglectUnited States
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University of UtahNot yet recruitingStroke | Perceptual Disorders | BiomarkerUnited States
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Nova Scotia Health AuthorityNot yet recruitingSpatial Neglect