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Intensive Interdisciplinary Treatment Program for Individuals With Stroke-Induced Aphasia

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intensive Comprehensive Aphasia Program
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of mild or moderate profile of aphasia secondary to a single stroke, as diagnosed by a certified speech-language pathologist.
  • Must be able to demonstrate auditory comprehension at a level that is functional for conversation.
  • Must demonstrate mobility or sensory deficits as a result of the stroke.
  • Must demonstrate cardiac/nutritional needs.
  • Must be able to ambulate without the physical assistance of another person for at least 500 feet.
  • Must be able to negotiate elevator and stairs independently
  • Must be able to manage bathroom needs without assistance.
  • Must be more than twelve months post-onset of stroke.
  • Must be between 18 and 75 years of age.
  • Must be native speakers of English
  • Must have 8th grade level of education or higher.
  • Must have adequate vision for functional reading
  • Must have adequate hearing for conversation

Exclusion Criteria:

  • Subjects who meet the above inclusion criteria, but who are also bilingual, and/or have concomitant neurological disease will be excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intensive Treatment for Aphasia

    Arm Description

    Outcomes

    Primary Outcome Measures

    Stroke Impact Scale (to assess change)
    QoL indicator for stroke survivors
    Canadian Occupational Performance Measure (to assess change)
    Measures participation and satisfaction in meaningful activities

    Secondary Outcome Measures

    Goal Attainment Scaling (to assess change)
    Measures attainment of individualized/personal community-based goals

    Full Information

    First Posted
    March 21, 2017
    Last Updated
    March 24, 2017
    Sponsor
    Boston University Charles River Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03096015
    Brief Title
    Intensive Interdisciplinary Treatment Program for Individuals With Stroke-Induced Aphasia
    Official Title
    Intensive Interdisciplinary Treatment Program for Individuals With Stroke-Induced Aphasia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (Actual)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Boston University Charles River Campus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    An intensive, interdisciplinary treatment program was administered during the summer as part of regular clinic services in the Aphasia Resource Center (ARC) at Sargent College. This program was run program as described for three years. Not more than six native English speakers with mild or moderate profiles of aphasia and multidisciplinary rehabilitation needs (OT,PT, SLP and nutrition) were recruited from the Boston community to participate in an intensive interdisciplinary treatment program for four weeks during the month of June 2013. The program consists of approximately six hours of interdisciplinary treatment each day, five days per week over a four-week interval. Treatment is individualized using current evidence-based treatment approaches, which are commonly accepted protocols in clinical practice and will be administered by clinical faculty and staff from Speech-Language and Hearing Sciences, Occupational Therapy (OT), Physical Therapy (PT), the Center for Neurorehabilitation and Nutrition. Segments of these types of treatments are available for a small fee as part of our service in the Aphasia Resource Center; however, this comprehensive, interdisciplinary program is not available of this research study. Approximately 30 hours of therapy per week are provided -- 6 hours per day over 5 days consisting of Speech-language Pathology, Physical Therapy, Occupational Therapy, and Nutrition Counseling.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aphasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Within-subjects Group design
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intensive Treatment for Aphasia
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intensive Comprehensive Aphasia Program
    Primary Outcome Measure Information:
    Title
    Stroke Impact Scale (to assess change)
    Description
    QoL indicator for stroke survivors
    Time Frame
    1 month pre intervention, immediately prior to intervention, the week post intervention, 3 months after intervention was completed
    Title
    Canadian Occupational Performance Measure (to assess change)
    Description
    Measures participation and satisfaction in meaningful activities
    Time Frame
    1 month pre intervention, immediately prior to intervention, the week post intervention, 3 months after intervention was completed
    Secondary Outcome Measure Information:
    Title
    Goal Attainment Scaling (to assess change)
    Description
    Measures attainment of individualized/personal community-based goals
    Time Frame
    1 month pre intervention, immediately prior to intervention, the week post intervention, 3 months after intervention was completed

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of mild or moderate profile of aphasia secondary to a single stroke, as diagnosed by a certified speech-language pathologist. Must be able to demonstrate auditory comprehension at a level that is functional for conversation. Must demonstrate mobility or sensory deficits as a result of the stroke. Must demonstrate cardiac/nutritional needs. Must be able to ambulate without the physical assistance of another person for at least 500 feet. Must be able to negotiate elevator and stairs independently Must be able to manage bathroom needs without assistance. Must be more than twelve months post-onset of stroke. Must be between 18 and 75 years of age. Must be native speakers of English Must have 8th grade level of education or higher. Must have adequate vision for functional reading Must have adequate hearing for conversation Exclusion Criteria: Subjects who meet the above inclusion criteria, but who are also bilingual, and/or have concomitant neurological disease will be excluded from the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intensive Interdisciplinary Treatment Program for Individuals With Stroke-Induced Aphasia

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