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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03096015
Other study ID # 3174E
Secondary ID
Status Completed
Phase N/A
First received March 21, 2017
Last updated March 24, 2017
Start date April 2013
Est. completion date October 2015

Study information

Verified date March 2017
Source Boston University Charles River Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intensive Comprehensive Aphasia Program


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Boston University Charles River Campus

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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