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AphasiaNCT03326687

Pairing Word Retrieval and Physical Endurance Tasks to Treat Anomia in People With Aphasia

A study testing Treatment ABAB and Treatment BABA in people with Aphasia, run by University of Nebraska Lincoln at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Aphasia
What is being tested?
Treatment ABAB and Treatment BABA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 May 2018to 8 Jun 2018
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Quality Living

    Omaha, Nebraska, 68104

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Aphasia
Being tested
Treatment ABAB, Treatment BABA
Keywords
Language, Anomia, Therapy
Medical subject headings
Aphasia, Language, Anomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment ABABBehavioural

    Participants will perform the phases in the ABAB order.

  • Treatment BABABehavioural

    Participants will perform the phases in the BABA order.

Study groups in NCT03326687
Study groupRoleWhat they receive
Treatment ABABExperimentalParticipants 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.
Receives: Behavioral: Treatment ABAB
Treatment BABAExperimentalParticipants 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.
Receives: Behavioral: Treatment BABA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One or two times daily until discharge from the facility (up to 24 weeks).

Secondary outcomes (3)
  1. 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.

    Measured: One or two times daily until discharge from the facility (up to 24 weeks).

  2. 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.

    Measured: Two times per week until discharge from the facility (up to 24 weeks).

  3. 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.

    Measured: Two times per week until discharge from the facility (up to 24 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2017
  2. Study start1 May 2018
  3. Primary completion8 Jun 2018
  4. Study completion8 Jun 2018

Why it stopped: Insufficient personnel

Resources

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
Randomised
Intervention model
Parallel groups
Model description
All participants will receive both the isolated and combined treatments in an ABAB or BABA order of phases.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03326687
Sponsor's protocol ID
17337
Status last verified
Jun 2018
First submitted
20 Oct 2017
Last updated
13 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Treatment ABAB and Treatment BABA in people with Aphasia, run by University of Nebraska Lincoln at 1 site in United States.

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 8 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: withdrawn, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 was withdrawn before enrolling participants, so there are no results.

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?

Number of words named in a category (time frame: One or two times daily until discharge from the facility (up to 24 weeks).). 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 13 Jun 2018.

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