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AphasiaNCT05307796

Incorporating Strategy Training Into Naming Treatment in Aphasia

A study testing Strategy training in people with Aphasia, run by MGH Institute of Health Professions at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study incorporates metacognitive strategy training into semantic feature analysis treatment. Semantic feature analysis treatment has a strong evidence base and capacity to improve word retrieval by encouraging circumlocution. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Aphasia
What is being tested?
Strategy training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
30 Aug 2021to 11 May 2022
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 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Experienced a single left-hemisphere stroke,
  • Have aphasia due to stroke,
  • Be in the chronic stages of their aphasia, at least 6 months post onset of stroke.
  • Be between the ages of 18 and 89 years of age, and
  • Be a proficient English speaker,
  • Have no history of neurodegenerative disease, motor speech disorder, significant mental illness, psychiatric disorder, drug/alcohol abuse, or neurological condition that could influence their cognitive, language, and memory systems.

Who cannot join

  • Experienced multiple strokes;
  • Be in the acute stage of their aphasia, <6 months post onset of stroke;
  • Have a diagnosis of neurodegenerative disease, significant mental illness, psychiatric disorder, drug/alcohol abuse, or neurological condition that could influence cognitive, language, and memory systems

Trial locations and contacts

1 site in 1 country.

United States1 site
  • MGH-Institute of Health Professions

    Boston, Massachusetts, 02129

Other trials in United States

About this study

Official title: Incorporating Strategy Training Into Naming Treatment to Improve Generalization in Aphasia

This study incorporates metacognitive strategy training into semantic feature analysis treatment. Semantic feature analysis treatment has a strong evidence base and capacity to improve word retrieval by encouraging circumlocution. Circumlocution facilitates self-cued naming and assists listener comprehension when naming fails. However, semantic feature analysis treatment does not include direct techniques to teach patients with aphasia to generalize the use of semantic feature analysis treatment's circumlocution procedure. Therefore, this study proposes that combining semantic feature analysis treatment and metacognitive strategy training will stimulate the semantic system and increase patients with aphasias' use of circumlocution across divergent contexts.

This study aims to measure the treatment's effect on naming accuracy for trained and untrained items. The study also aim to measure the treatment's effect on people with aphasias' knowledge of the strategy components and changes in verbalizations during retrieval attempts. The central hypothesis is that strategy training will increase patients with aphasias' explicit knowledge about circumlocution and enable them to use it to (1) self-facilitate naming, and (2) produce more informative connected speech.

Read the detailed description

Every 40 seconds, someone in the United States suffers from a stroke. Approximately 25% of stroke survivors acquire aphasia, a communication disorder that can result in a partial or total loss of spoken and written language ability, which significantly and negatively impacts quality of life and societal participation. The ability to verbally label objects, referred to as 'naming' in the literature, is impaired in all patients with aphasia. Naming is, therefore, a common focus of treatment. Naming treatments improve people with aphasias' naming ability for items that are directly trained during therapy. However, these same treatments face two critical limitations: (1) inconsistent generalization to untrained items, and (2) little to no generalization to spontaneous, connected speech. As it is impossible to train the entire universe of objects during a patient's course of therapy, generalization of gains beyond what is trained in therapy is crucial.

Recent work shows that patients with aphasias' learning success depends on their ability to develop optimal strategies that support learning, but that they do not develop these strategies independently. There is also evidence that through explicit strategy training, patients with aphasia can learn to implement and generalize the use of strategies that are known to support learning, and carry over their use across multiple environments. As such, it is predicted that naming treatment outcomes would be greatly improved by incorporating strategy training into treatment.

This study proposes to incorporate strategy training into naming treatment to improve generalization. Circumlocution, a verbal behavior in which patients with aphasia describe an object's features if they are unable to name it, is known to facilitate naming and assist listener comprehension. Semantic Feature Analysis is a well-regarded naming treatment thought to encourage circumlocution. Semantic Feature Analysis treatment does not include direct techniques that teach patients with aphasia how to generalize the use of the treatment's circumlocution procedure. In fact, no studies have explicitly trained patients with aphasia how to use the circumlocution procedure they learn in Semantic Feature Analysis treatment during everyday communication. Rather, it is assumed that patients with aphasia will implicitly learn how to use the procedure, through repeated practice and habituation alone. This study proposes that strategy training is the integral missing piece that will successfully result in people with aphasias' generalized application of the semantic feature analysis procedure.

The objective of the proposed research is to determine whether naming treatment that incorporates strategy training results in people with aphasias' increased use of circumlocution. The central hypothesis is that strategy training will increase patients with aphasias' explicit knowledge about circumlocution and enable them to use it to (1) self-facilitate naming, and (2) produce more informative connected speech. It is predicted that increased use of circumlocution will result in generalization at both the impairment level (naming) and participation level (effective communication).

Conditions
Aphasia
Being tested
Strategy training
Keywords
Aphasia; Naming; Circumlocution
Medical subject headings
Aphasia

What participants receive

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

  • Strategy trainingBehavioural

    The strategy training of focus in this study is metacognitive strategy training intended to build awareness of naming and methods to overcome instances of difficult naming. Strategy training involves (a) teaching the participant to identify instances in which they are unable to name objects, (b) learn a 6-feature framework (e.g. group, use, action) that has been identified to support semantic feature activation in aphasia, (c) learn and practice strategies to utilize the framework in instances of word finding difficulty

Study groups in NCT05307796
Study groupRoleWhat they receive
Semantic Feature Analysis plus metacognitive strategy trainingExperimentalParticipants attend three treatment sessions per week for eight weeks. Treatment sessions include: strategy education (participants learn about anomia, circumlocution, and circumlocution's purpose), Semantic Feature Analysis plus strategy application (participants build self-awareness and practice circumlocution), and strategy debriefing (participants reflect and receive feedback on their performance, and generate scenarios in which they could use the strategy in everyday life).
Receives: Behavioral: Strategy training

What is being measured

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

  1. Naming accuracy

    Number of pictures named accurately when looking at a series of 176 object pictures

    Measured: Change from baseline at 6 months

  2. Strategy Use

    Number of instances of circumlocution in moments of naming difficulty when looking at a series of 176 object pictures

    Measured: Change from baseline at 6 months

  3. Strategy Knowledge

    Number of strategy components (out of 6) participants identify (verbally or gesturally) independently

    Measured: Change from baseline at 6 months

Secondary outcomes (1)
  1. Content Information Units

    Number of content information units (CIUs) in connected speech samples when describing pictures and telling stories.

    Measured: Change from baseline at 6 months

Timeline

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

  1. First posted1 Apr 2022
  2. Study start30 Aug 2021
  3. Primary completion11 May 2022
  4. Study completion11 May 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05307796
Sponsor's protocol ID
2021P000705
Status last verified
Mar 2024
First submitted
22 Mar 2022
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Investigators will share de-identified data sets, statistical analysis codes and experimental set-ups with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with NIH policies.

Questions about this trial

What is this clinical trial studying?

A study testing Strategy training in people with Aphasia, run by MGH Institute of Health Professions 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 6 inclusion and 3 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 13 Mar 2024. 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 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?

Naming accuracy (time frame: Change from baseline at 6 months). The study lists 3 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 13 Mar 2024.

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