NCT02068664

Brief Summary

The purpose of this study is to determine if stroke survivors with aphasia have spatial neglect (Phase 1). If they are determined to have the condition Phase 2 will be offered: which is prism adaptation treatment. This is a pilot study that will be performed with 4-5 subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

February 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

February 12, 2014

Last Update Submit

August 16, 2017

Conditions

Keywords

spatial neglectaphasia

Outcome Measures

Primary Outcomes (1)

  • Kessler Foundation Neglect Assessment Process

    a performance based and behavioral measure for spatial neglect that utilizes and standardizes the administration of the Catherine Bergego Scale (CBS)

    2 weeks

Secondary Outcomes (3)

  • Behavior Inattention Test

    2 weeks

  • Barthel Index

    2 weeks

  • University of Alabama at Birmingham (UAB) Life Space assessment

    2 weeks

Study Arms (1)

Observational

prism adaptation treatment

Behavioral: prism adaptation treatment

Interventions

Prism goggles shift the image one sees toward the left (because the thicker portion of the glass lens is on the right). This will change the perception of where the image is in space, causing the person to adapt. The after-effects of the treatment is what is important. It has been shown to make it easier for people to move in the right space (if have right neglect) or improves ability to complete other functional tasks.

Observational

Eligibility Criteria

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

Stroke survivors with aphasia and spatial neglect

You may qualify if:

  • A stroke survivor with aphasia who is a member at the Adler Aphasia Center

You may not qualify if:

  • Has a history of brain tumor, head injury with loss of consciousness, dementia, alzheimers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adler Aphasia Center

Maywood, New Jersey, 07607, United States

Location

Related Links

MeSH Terms

Conditions

AphasiaStroke

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kimberly Hreha, OT

    Kessler Foundation/Kessler Institute for Rehabilitation

    PRINCIPAL INVESTIGATOR
  • A.M. Barrett, M.D.

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 21, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 21, 2017

Record last verified: 2017-08

Locations