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The purpose of the study is to determine if speech therapy can be enhanced by Aerobic Exercise (AE). Investigators will use a single subject design to determine if aphasia therapy result in greater gains when combined with aerobic exercise.
Aim 1: To test the feasibility of a research study that combines speech therapy with aerobic exercise (AE). Participants will be alternately assigned to receiving AE during during a 30 minute break from speech therapy.
Aim 2: To test the preliminary efficacy of combining speech therapy with AE to promote language improvements in aphasia. These data will inform the design of a large, controlled clinical trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental |
| |
| Treatment 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Language therapy | Behavioral | There will be three blocks of treatment, ideally three times a week 100 minutes per day. Treatment will target impairment-directed speech language therapy (SLT) approaches or compensatory-directed SLT in each of the three treatment blocks. Half of the participants will receive the impairment-directed SLT. Half of the participants, will receive treatment that will target compensatory-directed speech language therapy approaches that are focused on functional communication skills in the conversational context. Methods of treatment will include PACE (Promoting Aphasics Communicative Effectiveness (Davis, 2005), conversational coaching (Hopper et al., 2002), and supported conversation (Kagan et al., 2001). The clinician will model and encourage all (verbal and non verbal) modalities of communication. |
| Measure | Description | Time Frame |
|---|---|---|
| The Aphasia Communication Outcome Measure (ACOM) (Hula et al., 2015) | Patient-reported outcome measure of communicative functioning for persons with aphasia | 24 Weeks |
| The Boston Naming Test | The examiner begins with Item 1 and continues through Item 60, unless the patient is in distress or refuses to continue. The patient is told to tell the examiner the name of each picture and is given about 20 seconds to respond for each trial. The examiner writes down the patient's responses in detail, using codes. If the patient fails to give the correct response, the examiner at her or his discretion may give the patient a phonemic cue, which is the initial sound of the target word. After the patient completes the test, the examiner scores each item + or - according to the response coding and scoring procedures | 24 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
MD considers participant unable to comply with study requirements.
MD evaluates medication history and determines if current medications will have a negative impact and if so MD will not recommend patient inclusion.
Mood will first be screened by the Beck Depression Inventory screen and then assessed with the Beck Depression Inventory (BDI) if the participant does not pass the screening. This is a 21-item self-report assessment designed specifically to identify depression. The items are scored 0 (no problem) to 3. Thus, the possible score is between 0 - 63. A score of 9 or lower is the usual threshold to separate depressed from non-depressed subjects. If a subject scores 10 or higher the subject will not be included in the study and the MD will discuss with the subject the possibility of a referral for a psychiatric evaluation.
Stroke due to intracranial hemorrhage primarily due to bleeding from ruptured aneurysm or arteriovenous malformation.
Progressive stroke (primary progressive aphasia diagnosis)
Comorbid neurological diagnosis (e.g. MS, PD, dementia)
Unable to perform the required exercises due to a) medical, b) musculo-skeletal, or c) neurological problems (for details see below, a-c)
Drug or alcohol addiction within the last 6 months.
Significant current psychiatric illness defined as affective disorder unresponsive to medication or bipolar affective disorder, psychosis, schizophrenia or suicidality.
Current participation in another interventional trial.
Vulnerable Subjects
ed deficits Required help of at least 1 person to walk before stroke due to neurological (for example, advanced Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis) or non-neurological (for example, heart failure, orthopaedic problems) co-morbidities with life expectancy of less than 1 year as determined by physician.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Galletta, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D007808 | Language Therapy |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Background Music | Behavioral | 30 minutes background music only |
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| Aerobic Exercise | Behavioral | There will be three blocks of treatment and the AE will take place for all participants during one or two treatment blocks (randomly assigned), threetimes a week (sessions are three times a week prior to speech therapy but may be one or two times a week if a session is missed or may be up to four or five times a week if one or two sessions are missed and rescheduled due to weather or other circumstances). |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |