NCT04977219

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

3.6 years

First QC Date

July 9, 2021

Last Update Submit

July 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Functional Independence Measure (FIM)

    Up to 55 days

  • Length of Stay

    Up to 55 days

  • Discharge destination

    Up to 55 days

Study Arms (2)

Prism Adaptation Training;

Patients who received prism adaptation training for treatment of spatial neglect during their inpatient rehabilitation admission

Behavioral: Prism Adaptation Training

Standard Care

Patients who received standard treatment of spatial neglect during their admission

Interventions

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.

Prism Adaptation Training;

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatient Rehabilitation Facility (IRF)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gillen RW, Harmon EY, Weil B, Fusco-Gessick B, Novak PP, Barrett AM. Prism Adaptation Treatment of Spatial Neglect: Feasibility During Inpatient Rehabilitation and Identification of Patients Most Likely to Benefit. Front Neurol. 2022 Apr 1;13:803312. doi: 10.3389/fneur.2022.803312. eCollection 2022.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Neuropsychologist

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 26, 2021

Study Start

June 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share