Intensive Interdisciplinary Treatment Program for Individuals With Stroke-Induced Aphasia

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.

Study Overview

• Status: Completed
• Conditions: Aphasia
• Intervention / Treatment: Behavioral: Intensive Comprehensive Aphasia Program

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Impact Scale (to assess change)	QoL indicator for stroke survivors	1 month pre intervention, immediately prior to intervention, the week post intervention, 3 months after intervention was completed
Canadian Occupational Performance Measure (to assess change)	Measures participation and satisfaction in meaningful activities	1 month pre intervention, immediately prior to intervention, the week post intervention, 3 months after intervention was completed

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: 3174E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No