Pairing Word Retrieval and Physical Endurance Tasks to Treat Anomia in People With Aphasia
Primary Purpose
Aphasia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment ABAB
Treatment BABA
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring Language, Anomia, Therapy
Eligibility Criteria
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:
-
Sites / Locations
- Quality Living
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment ABAB
Treatment BABA
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Number of words named in a category
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.
Secondary Outcome Measures
Distance traveled (in feet) while using an exercise machine
The participant will walk on an exercise machine. The distance (measured in feet) will be measured during a five-minute time period.
Number of words generated during discourse
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.
Distance traveled (in feet) while walking
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.
Full Information
NCT ID
NCT03326687
First Posted
October 20, 2017
Last Updated
June 11, 2018
Sponsor
University of Nebraska Lincoln
Collaborators
Quality Living, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03326687
Brief Title
Pairing Word Retrieval and Physical Endurance Tasks to Treat Anomia in People With Aphasia
Official Title
Pairing Word Retrieval and Physical Endurance Tasks to Treat Anomia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient personnel
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
June 8, 2018 (Actual)
Study Completion Date
June 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska Lincoln
Collaborators
Quality Living, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
Language, Anomia, Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All participants will receive both the isolated and combined treatments in an ABAB or BABA order of phases.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment ABAB
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment BABA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment ABAB
Intervention Description
Participants will perform the phases in the ABAB order.
Intervention Type
Behavioral
Intervention Name(s)
Treatment BABA
Intervention Description
Participants will perform the phases in the BABA order.
Primary Outcome Measure Information:
Title
Number of words named in a category
Description
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.
Time Frame
One or two times daily until discharge from the facility (up to 24 weeks).
Secondary Outcome Measure Information:
Title
Distance traveled (in feet) while using an exercise machine
Description
The participant will walk on an exercise machine. The distance (measured in feet) will be measured during a five-minute time period.
Time Frame
One or two times daily until discharge from the facility (up to 24 weeks).
Title
Number of words generated during discourse
Description
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.
Time Frame
Two times per week until discharge from the facility (up to 24 weeks).
Title
Distance traveled (in feet) while walking
Description
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.
Time Frame
Two times per week until discharge from the facility (up to 24 weeks).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen A Hux, PhD
Organizational Affiliation
University of Nebraska Lincoln
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carly R Dinnes, MA
Organizational Affiliation
University of Nebraska Lincoln
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quality Living
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The researchers do not plan to share IPD because of the potential for violation of participants' privacy and confidentiality is too great given the participant pool.
Learn more about this trial
Pairing Word Retrieval and Physical Endurance Tasks to Treat Anomia in People With Aphasia
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