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
About this trial
This is an interventional treatment trial for Aphasia
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.
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
NCT ID
NCT03096015
First Posted
March 21, 2017
Last Updated
March 24, 2017
Sponsor
Boston University Charles River Campus
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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