Living With Aphasia: An International Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by New York University School of Medicine
Sponsor:
Collaborators:
The Toula Stroke Rehabilitation Research Fund
The Solomon Foundation
The University of Queensland
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01234090
First received: October 15, 2010
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

This prospective cohort study hypothesizes that an analysis of parallel qualitative and quantitative data is necessary to examine the full experience of living with aphasia. It is also hypothesized that there are specific factors that act as barriers or facilitators to successfully living with aphasia. A unique aspect of the project is the use of the Assessment for Living with Aphasia (ALA), a new aphasia friendly measure based on the World Health Organization International Classification of Functioning, Disability and Health (WHO ICF). Each session will assess written and spoken language, functional communication, mobility, Activities of Daily Living (ADL) function, burden of stroke, quality of life, and depression.


Condition
Aphasia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Living With Aphasia: An International Study

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • The Assessment for Living with Aphasia [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    A new, aphasia friendly measure based on the World Health Organization International Classification of Functioning, Disability, and Health. It is a specialized tool using a self-rating scale and is focused on specific themes that have emerged from previous research.


Secondary Outcome Measures:
  • Western Aphasia Battery - Revised [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    This measure is designed to assess clinical aspects of language functions in aphasic patients and to provide the data needed to establish a prognosis for therapy.

  • Successfully Living with Aphasia Rating Scale [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    This scale is a quantitative self-rating of how successfully a person is living with aphasia.

  • Burden of Stroke Scale [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The Burden of Stroke Scale is a health-status assessment instrument designed to measure patient-reported difficulty in multiple domains of functioning, psychological distress associated with specific functional limitations, and general well-being in stroke survivors.

  • Aphasia Depression Rating Scale [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The Aphasic Depression Rating Scale (ADRS) was developed to detect and measure depression in aphasic patients during the subacute stage of stroke.

  • The Wepman Self-Correction Scale [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    This scale, based on a continuum, measures disturbances in the ability of the person with aphasia to self-correct speech and language errors.

  • The Barthel Index [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    This measure is a simple index of independence to score the ability of a patient with a neuromuscular or musculoskeletal disorder to care for himself.

  • The Functional Communication Profile [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    This rating scale is for persons with aphasia which considers 45 everyday communication behaviors. Ratings of each behavior are made on a 9-point scale, based on observations of the patient during an informal conversation.


Estimated Enrollment: 204
Study Start Date: June 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Persons with Aphasia

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Inpatient/outpatient hospital population

Criteria

Inclusion Criteria:

  • 18 years of age and older, willingness to be videotaped, first incidence of aphasia secondary to stroke with stroke onset ≤2.5
  • months pre-stroke or 3.5 months post-stroke with no significant complicating concomitant conditions (e.g. dementia, schizophrenia),
  • premorbid fluency/literacy in English, and no history of psychiatric disorder, and sufficient communication ability (including adequate hearing and vision) in English to participate in an interview as determined by a qualified speech pathologist based on administration of the Western Aphasia Battery - Revised and clinical observation.
  • participants will be enrolled in the study at 3 months post onset (+/- 2 weeks) wherever they are living, and presence of aphasia will be confirmed at the beginning of the first interview using the Aphasia Quotient cut offs of the Western Aphasia Battery.
  • participants with severe global aphasia will only be excluded after the interview if meaningful responses cannot be obtained using all available communication support tools. Hence, participants with a range of aphasia severity will be included.

Exclusion Criteria:

  • unwillingness to be videotaped
  • onset of stroke <2.5 months post and >3.5 months post
  • moderate or severe dementia
  • symptoms of another preexisting neurological condition other than or in addition to aphasia due to stroke, or drug abuse
  • neurological surgical treatment not including a surgical treatment specifically for treatment of stroke, absence of aphasia.
  • no subjects will have a hearing loss unexpected for his/her chronological age.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234090

Contacts
Contact: Jessica F Galgano, PhD 212-430-6800 jessica.galgano@nyumc.org
Contact: Martha T Sarno, MA,Dhonorary 212-263-6520 martha.sarno@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Jessica F Galgano, PhD    212-430-6800    jessica.galgano@nyumc.org   
Contact: Martha T Sarno, MA,Dhonorary    212-263-6520    martha.sarno@nyumc.org   
Sub-Investigator: Jessica F Galgano, PhD         
Principal Investigator: Martha T Sarno, MA,Dhonorary         
Principal Investigator: Leonard Diller, PhD         
Sponsors and Collaborators
New York University School of Medicine
The Toula Stroke Rehabilitation Research Fund
The Solomon Foundation
The University of Queensland
Investigators
Principal Investigator: Martha T Sarno, MA,Dhonorary New York University School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01234090     History of Changes
Other Study ID Numbers: 10-01628
Study First Received: October 15, 2010
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Aphasia
Quality of Life

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014