AphasiaNCT03096015
Intensive Interdisciplinary Treatment Program for Individuals With Stroke-Induced Aphasia
A study testing Intensive Comprehensive Aphasia Program in people with Aphasia, run by Boston University Charles River Campus.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aphasia
- What is being tested?
- Intensive Comprehensive Aphasia Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- Subjects who meet the above inclusion criteria, but who are also bilingual, and/or have concomitant neurological disease will be excluded from the study.
About this study
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.
- Conditions
- Aphasia
- Being tested
- Intensive Comprehensive Aphasia Program
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Comprehensive Aphasia ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intensive Treatment for Aphasia | Experimental | Not described Receives: Behavioral: Intensive Comprehensive Aphasia Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Impact Scale (to assess change)
QoL indicator for stroke survivors
Measured: 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
Measured: 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)
Measures attainment of individualized/personal community-based goals
Measured: 1 month pre intervention, immediately prior to intervention, the week post intervention, 3 months after intervention was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study startApr 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subjects Group design
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Hoover, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096015
- Sponsor's protocol ID
- 3174E
- Status last verified
- Mar 2017
- First submitted
- 21 Mar 2017
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Interdisciplinary Treatment Program for Individuals With Stroke-Induced Aphasia
- ClinicalTrials.gov ID
- NCT03096015
- Acronym / sponsor ID
- 3174E
- Conditions
- Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-subjects Group design
| Arm | Type | Receives |
|---|---|---|
| Intensive Treatment for Aphasia | Experimental | Behavioral: Intensive Comprehensive Aphasia Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects who meet the above inclusion criteria, but who are also bilingual, and/or have concomitant neurological disease will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Comprehensive Aphasia Program | Behavioural | Intensive Treatment for Aphasia |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Aphasia
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Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Comprehensive Aphasia Program in people with Aphasia, run by Boston University Charles River Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017; AzTrials last refreshed its copy on 1 Nov 2026.