Ecological Momentary Intervention for Post-Stroke Anomia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorNortheastern University

About this trial

Anomia (i.e., impaired word retrieval) is one of the most common and debilitating deficits experienced by stroke survivors with aphasia, an acquired disorder characterized by impaired language. Although many anomia treatments exist, treatment response is modest and inconsistent across studies, and the extent of generalization to everyday contexts-the therapy gold standard-is largely unknown. The critical gap between actual outcomes and the therapeutic potential of naming therapy is tied to problems with current treatment delivery practices (i.e., low/unknown dosage, massed practice delivery, and decontextualized training). In this research, we aim to demonstrate that a novel smartwatch-based ecological momentary intervention (EMI) that delivers high-dosage semantic feature training throughout daily life has the potential for overcoming these issues. Every day for six weeks, 20 PWA will complete 24 trials of semantic feature EMI distributed over the day (from 10am-8pm) and delivered by a smartwatch. The EMI trial flow will include five steps: 1) a prompt alert and audiovisual "Ready to name a picture?" cue, 2) a first naming attempt after a YES response, 3) the repetition of an auditory model, 4) semantic feature verification via yes/no questions, and 5) a second naming attempt. To contextualize training further, trained items will be clustered into location categories (e.g., home, pharmacy), and we will use the mobile device's location detection to match PWA's location and item category for \~50% of trials. In Aim #1, we will establish preliminary efficacy of this EMI by determining the extent to which semantic feature EMI improves naming of trained items and generalizes to untrained, related contexts. We predict that the EMI will significantly improve 1) naming of trained items and semantically related, untrained items relative to semantically unrelated items and 2) subjective and objective measures of functional communication effectiveness. Given the novelty of our EMI, the second two aims will focus on identifying key factors of semantic feature EMI user experience (Aim #2) and trends between therapy response and the treatment delivery factors of dosage, trial spacing, and item-location congruence (Aim #3). The proposed research is innovative because of the novel use of EMI for aphasia, our combined application of distributed practice and context-dependent training, and the future promise of extending our system to other types of evidence-based treatment and to other clinical populations, as well as to in-situ "just-in-time" interventions that can intervene in real time during the moment of communication breakdown. The significance of this research lies in its ability to provide technology that automatically tracks dosage metrics; its potential for increasing knowledge regarding which therapy delivery factors impact outcomes; and its promise for providing PWA alternative paths to receive therapy. Successful completion of this research will lead to an R01 application aimed at establishing the efficacy of this novel therapy compared to gold-standard, clinician-provided treatment and determining which active treatment ingredients contribute to outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Current/pre-stroke English proficiency

Normal/corrected-to-normal vision and hearing

Medical stability

History of left hemisphere stroke at least six months prior to enrollment.

Disqualifiers

Diagnosis of neurological disease affecting the brain (besides stroke)

Major psychiatric disorders

Recent history of falls within six months of enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • Semantic Feature Ecological Momentary Intervention

    Behavioral

    If answered, each prompt will correspond to a single picture naming training trial. The trial flow will include five steps: (1) an initial vibration/chime prompt and audiovisual "Ready to name a picture?" question, (2) a first naming attempt upon a button YES response to the "Ready?" question, (3) an audiovisual model of the target word, (4) an audiovisual cue of "Get ready to answer some questions!" followed by a series of six yes/no semantic feature questions, and (5) a second and final naming attempt upon a YES response to the audiovisual "Ready to name a picture?" question. If the participant taps NO to any "Ready?" question or ignores the prompt, the trial flow will end, and they will be re-prompted once more 10 minutes later. If they ignore or respond NO to the re-prompt, that trial will be skipped. PWA will have 10 seconds to respond to Steps #2, #3, and #5.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Semantic Feature Ecological Momentary InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Accuracy on Trained Items

Each participant will receive semantic feature intervention for 24 trained words. Accuracy will be assessed via naming probes administered before, during (at the end of each week), and after therapy. Accuracy will be coded as 0 for incorrect and 1 for correct on each naming probe. Improvement in accuracy on trained items will be compared to change over time on a set of 24 untrained words that are not semantically related to the trained items.

Time frame
7 weeks (from before the intervention to the one-week follow-up)

Secondary outcomes

1

Accuracy on Semantically Related, Untrained Items

A list of 12 items that are related in meaning (i.e., semantically related) to the 24 trained items will be identified and monitored over the course of therapy. Specifically, accuracy for these items will also be assessed via naming probes administered before, during (at the end of each week), and after therapy. Accuracy will be coded as 0 for incorrect and 1 for correct on each naming probe. Improvement in accuracy on the 12 semantically related, untrained items will be compared to change over time on a set of 12 untrained words that are not semantically related to the trained items.

Time frame
7 weeks (from before the intervention to the one-week follow-up)
2

Change in Functional Communication

The Aphasia Communication Outcome Measure (Hula et al., 2015) is a standardized assessment of subjective ratings of functional communication in which people with aphasia indicate how effectively they can accomplish what they want without help or taking too long on a variety of everyday communication tasks (e.g., ask for information from store employees, talk about current/previous work) via a visual scale. The AphasiaBank Discourse Protocol (MacWhinney et al., 2011) is a series of tasks in which individuals respond to open-ended questions, describe single pictures and picture sequences, describe a procedure, and retell a story in order to obtain measures reflecting discourse-level skills. Change in functional communication from before to after therapy will be determined by assessing the change in the Aphasia Communication Outcome Measure standardized score and change in percent correct information units produced in a set of the AphasiaBank tasks.

Time frame
7 weeks (from before the intervention to the one-week follow-up)

Other outcomes

Sponsors and contacts

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