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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04977219
Other study ID # 21-0505-3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2016
Est. completion date December 31, 2019

Study information

Verified date July 2021
Source Sunnyview Rehabilitation Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Prism Adaptation Training
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sunnyview Rehabilitation Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Catherine Bergego Scale Behavioral measure of unilateral spatial neglect. Scored 0-30. Higher numbers indicate greater severity of spatial neglect. Up to 55 days
Secondary Functional Independence Measure (FIM) 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
Secondary Length of Stay Length of inpatient hospital admission Up to 55 days
Secondary Discharge destination Destination of patient following discharge: Home, Subacute nursing facility, Acute care hospital Up to 55 days
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