- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03326687
Pairing Word Retrieval and Physical Endurance Tasks to Treat Anomia in People With Aphasia
Pairing Word Retrieval and Physical Endurance Tasks to Treat Anomia
Many individuals have difficulty with word retrieval, also called anomia, following cerebrovascular accident (CVA). These difficulties impede effective communication in everyday conversations and can negatively impact the resumption of pre-injury activities. Even after rehabilitation specifically targeting these areas, many individuals report persistent difficulties with anomia. Additionally, most individuals report that these difficulties worsen when distracted, fatigued, or when attempting to divide attention between tasks. Given that everyday activities frequently require efficient communication when attention is divided (e.g., walking and talking), it is important to investigate viable interventions to improve these skills.
Recovery from CVA and resumption of pre-injury activities is best supported by rehabilitation interventions that are functional and directly related to the tasks individuals aim to resume. For example, a therapy task requiring an individual to generate a grocery list and then go to a grocery store to acquire the items on the list has a greater impact on recovery for the underlying language and cognitive skills than a series of generic language and cognition tasks completed in a therapy room. In addition to this, interventions that incorporate dual-task practices tend to have better outcomes than more traditional single-task practices.
The aim of this study is to compare the effectiveness of pairing word retrieval tasks with physical endurance tasks versus presenting them in isolation. Additionally, this study will investigate whether improvements in word retrieval and physical endurance generalize to the functional, everyday task of holding a conversation while walking. The researchers hypothesize that participants will perform better on word retrieval tasks after participating in dual language and physical tasks than after participating in language tasks presented in isolation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All data collection will occur at Quality Living (QLI).
The researchers will administer a set of standardized assessments prior to initiating the intervention program to determine eligibility for study participation as well as to gather descriptive information about the language abilities of participants. Assessments will include the Western Aphasia Battery - Revised and the Boston Naming Test. In addition to performing language assessments, participants will respond to demographic and injury-related questions and will identify preferred topics of conversation. The researchers will obtain information about each participant's physical status by referring to the physical therapy assessments and associated documentation completed by a QLI physical therapist shortly after the individual's arrival at QLI.
Intervention will occur five days per week and will take place during participants' regularly scheduled speech therapy sessions. Two intervention sessions will occur daily, one held in the morning and the second held in the afternoon. Depending on the activities performed on a given day, the total time devoted to intervention sessions will be 10 to 30 minutes (i.e., 5 to 15 minutes per session).
During each intervention session, the researchers will measure performance on one or more of the following tasks: (a) five trials of generative naming given a unique category and one-minute response period per trial, (b) distance traveled using an exercise machine for five minutes, (c) generative naming given unique categories and one-minute response periods and distance traveled using an exercise machine when performing both tasks simultaneously for five minutes, (d) number of words generated in five minutes in response to conversational topic prompts, (e) distance traveled when walking for five minutes, and (f) number of words generated in response to conversational topic prompts and distance traveled when walking when performing both tasks simultaneously for five minutes. The first three measures comprise intervention tasks, and the remaining three are generalization measures.
Intervention and generalization sessions will follow an overlapping ABAB or BABA format, with the first day of each phase being an overlap day. Participants will be randomly assigned to begin the intervention either with an A or B phase. On overlap days, the researchers will collect measures on all six intervention and generalization activities, with three being performed during a fifteen-minute morning session and three being performed during a fifteen-minute afternoon session. For participants in the A phase, the researchers will collect measures two times daily for each of the subsequent four days on the generative naming and exercise machine activities performed as independent tasks; for participants in the B phase, the researchers will collect measures two times daily for each of the subsequent four days on the generative naming and exercise machine activities performed as simultaneous tasks. A phase sessions will last ten minutes each, and B phase sessions will last five minutes each. The cycle of A and B phases will repeat throughout a participants inpatient stay at QLI. A QLI physical therapist will be present to monitor safety during performance of physical activities. The researchers will audio record all generative naming and conversational discourse activities for later analysis.
Participants will only perform naming, discourse, and physical endurance tasks that are included as part of their routine speech-language therapy and physical therapy sessions. However, completion of the physical endurance tasks will not occur during the participants' physical therapy sessions; instead, they will occur during speech-language therapy sessions. The naming and discourse tasks will also occur during the participants' speech-language therapy sessions.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68104
- Quality Living
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have acquired brain injury due to left cerebrovascular accident (CVA)
- Be older than 19 years of age
- Speak English as a native language
- Be less than 3 months post-left CVA at the time of participation initiation
- Use natural speech as a primary means of communicating
- Have hearing adequate for conversational speech
- Have mild to moderate deficits in word retrieval and physical endurance as a result of left CVA
- Be currently receiving treatment services at Quality Living for CVA-related deficits
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment ABAB
Participants will receive anomia treatment in isolation and will perform a physical endurance task in isolation during A phases.
They will receive anomia treatment in combination with performing a physical endurance task during B phases.
|
Participants will perform the phases in the ABAB order.
|
Experimental: Treatment BABA
Participants will receive anomia treatment in isolation and will perform a physical endurance task in isolation during A phases.
They will receive anomia treatment in combination with performing a physical endurance task during B phases.
|
Participants will perform the phases in the BABA order.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of words named in a category
Time Frame: One or two times daily until discharge from the facility (up to 24 weeks).
|
The researcher will provide a participant with a category label.
The participants will name as many words as he/she can in that category within a one-minute time period.
The researcher will tally the total number of unique and category-appropriate words named.
|
One or two times daily until discharge from the facility (up to 24 weeks).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distance traveled (in feet) while using an exercise machine
Time Frame: One or two times daily until discharge from the facility (up to 24 weeks).
|
The participant will walk on an exercise machine.
The distance (measured in feet) will be measured during a five-minute time period.
|
One or two times daily until discharge from the facility (up to 24 weeks).
|
Number of words generated during discourse
Time Frame: Two times per week until discharge from the facility (up to 24 weeks).
|
The researcher will give each participant a verbal prompt to initiate and sustain a five-minute discourse about one of the topics he/she selected prior to beginning the intervention.
The conversational interaction will be audio recorded for later analysis and tallying of the number of words generated by the participant.
|
Two times per week until discharge from the facility (up to 24 weeks).
|
Distance traveled (in feet) while walking
Time Frame: Two times per week until discharge from the facility (up to 24 weeks).
|
The participant will walk a specified route inside the Quality Living facility.
The distance (measured in feet) will be measured during a five-minute time period.
|
Two times per week until discharge from the facility (up to 24 weeks).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen A Hux, PhD, University of Nebraska Lincoln
- Principal Investigator: Carly R Dinnes, MA, University of Nebraska Lincoln
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17337 (Other Identifier: IND number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aphasia
-
University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedStroke | Aphasia | Stroke, Ischemic | Aphasia, Broca | Aphasia, Anomic | Aphasia, Global | Aphasia, Fluent | Aphasia, Mixed | Aphasia, Jargon | Aphasia, Expressive | Aphasia, ConductionUnited States
-
University of Texas at AustinUniversity of California, San Francisco; National Institute on Deafness and...Active, not recruitingPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
-
Institute for Bioengineering of CataloniaHospital Universitari Joan XXIII de Tarragona.; Universitat Pompeu FabraCompletedAphasia | Aphasia, Broca | Aphasia, Wernicke | Aphasia, Fluent | Aphasia, NonfluentSpain
-
Flint Rehabilitation Devices, LLCUniversity of TexasCompleted
-
Mayo ClinicNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingPrimary Progressive Aphasia | Apraxia of Speech | PPA | Non-fluent Aphasia | Primary Progressive Non-fluent AphasiaUnited States
-
University of California, BerkeleyUniversity of California, San Francisco; California State University, East Bay and other collaboratorsRecruitingAphasia | Aphasia, Acquired | Aphasia Non Fluent | Aphasia, FluentUnited States
-
Mayo ClinicCompletedPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | PPA | Non-fluent Aphasia | Progressive AphasiaUnited States
-
Montreal Heart InstituteActive, not recruitingNeurodegenerative Diseases | Primary Progressive Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Non-fluent AphasiaCanada
-
Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
-
University of British ColumbiaTerminatedPrimary Progressive Nonfluent AphasiaCanada
Clinical Trials on Treatment ABAB
-
PfizerCompleted
-
PfizerCompleted
-
Chiesi Farmaceutici S.p.A.Completed
-
Gilead SciencesCompletedChronic Lymphocytic LeukemiaUnited States
-
JW PharmaceuticalCompletedHealthyKorea, Republic of
-
PfizerCompleted
-
AstraZenecaParexelCompleted
-
Assistance Publique - Hôpitaux de ParisRecruitingIntra-articular Fracture of the Mandibular CondyleFrance
-
PfizerCompletedHealthy VolunteersUnited States
-
New Mexico VA Healthcare SystemCompletedPost Traumatic Stress DisorderUnited States