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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Semantic Feature Analysis plus metacognitive strategy training | Experimental | Participants 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.
Naming accuracy
Number of pictures named accurately when looking at a series of 176 object pictures
Measured: Change from baseline at 6 months
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
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)
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.
- First posted1 Apr 2022
- Study start30 Aug 2021
- Primary completion11 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- MGH Institute of Health Professions
- Sponsor type
- University, hospital or other
- Collaborators
- LSVT Global
- Responsible party
- Principal investigator, Sofia Vallila Rohter, MGH Institute of Health Professions
- Investigators
- Sofia Vallila Rohter, PhD, Principal investigator, MGH Institute of Health Professions
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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Strategy Training Into Naming Treatment to Improve Generalization in Aphasia
- ClinicalTrials.gov ID
- NCT05307796
- Acronym / sponsor ID
- 2021P000705
- Conditions
- Aphasia
- Keywords
- Aphasia; Naming; Circumlocution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MGH Institute of Health ProfessionsUniversity, hospital or other
- Collaborators
- LSVT Global
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semantic Feature Analysis plus metacognitive strategy training | Experimental | Behavioral: Strategy trainingParticipants 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). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strategy trainingThe 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 | Behavioural | Semantic Feature Analysis plus metacognitive strategy training |
Primary outcome
Naming accuracy
Time frame: Change from baseline at 6 months
Number of pictures named accurately when looking at a series of 176 object pictures
Strategy Use
Time frame: Change from baseline at 6 months
Number of instances of circumlocution in moments of naming difficulty when looking at a series of 176 object pictures
Strategy Knowledge
Time frame: Change from baseline at 6 months
Number of strategy components (out of 6) participants identify (verbally or gesturally) independently
1 secondary outcome
Content Information Units
Time frame: Change from baseline at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: 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.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofia Vallila Rohter, PhD principal investigator
MGH Institute of Health Professions
1 site in 1 country: see every site and its status.
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.