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Intensive Interdisciplinary Treatment Program for Individuals With Stroke-Induced Aphasia

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ClinicalTrials.gov Identifier: NCT03096015
Recruitment Status : Completed
First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Elizabeth Hoover, Boston University Charles River Campus

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.


Condition or disease Intervention/treatment Phase
Aphasia Behavioral: Intensive Comprehensive Aphasia Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Within-subjects Group design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Interdisciplinary Treatment Program for Individuals With Stroke-Induced Aphasia
Actual Study Start Date : April 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: Intensive Treatment for Aphasia Behavioral: Intensive Comprehensive Aphasia Program



Primary Outcome Measures :
  1. Stroke Impact Scale (to assess change) [ Time Frame: 1 month pre intervention, immediately prior to intervention, the week post intervention, 3 months after intervention was completed ]
    QoL indicator for stroke survivors

  2. Canadian Occupational Performance Measure (to assess change) [ Time Frame: 1 month pre intervention, immediately prior to intervention, the week post intervention, 3 months after intervention was completed ]
    Measures participation and satisfaction in meaningful activities


Secondary Outcome Measures :
  1. Goal Attainment Scaling (to assess change) [ Time Frame: 1 month pre intervention, immediately prior to intervention, the week post intervention, 3 months after intervention was completed ]
    Measures attainment of individualized/personal community-based goals



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Responsible Party: Elizabeth Hoover, Clinical Associate Professor, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT03096015     History of Changes
Other Study ID Numbers: 3174E
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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