NCT03096015

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

2.5 years

First QC Date

March 21, 2017

Last Update Submit

March 24, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Goal Attainment Scaling (to assess change)

    1 month pre intervention, immediately prior to intervention, the week post intervention, 3 months after intervention was completed

Study Arms (1)

Intensive Treatment for Aphasia

EXPERIMENTAL
Behavioral: Intensive Comprehensive Aphasia Program

Interventions

Intensive Treatment for Aphasia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Within-subjects Group design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 30, 2017

Study Start

April 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 30, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share