Stroke Clinical Trial
Official title:
Prism Adaptation Training for Treatment of Spatial Neglect During Inpatient Rehabilitation
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 |
Verified date | July 2021 |
Source | Sunnyview Rehabilitation Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sunnyview Rehabilitation Hospital |
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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