search
Back to results

Adaptive Trial Scheduling in Naming Treatment for Aphasia

Primary Purpose

Aphasia, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adaptive Spacing Condition
High-Item Non-Adaptive Spacing Condition
Low-Item Non-Adaptive Spacing Condition
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Existing diagnosis of chronic (>6 months) aphasia subsequent to left hemisphere stroke. Impaired performance on 2/8 sections of the Comprehensive Aphasia Test. Must have access to a high-speed internet connection and be able to participate in telehealth. Exclusion Criteria: History of other acquired or progressive neurological disease. Significant language comprehension impairments (per performance on the CAT - individuals will be excluded if their spoken language comprehension mean modality T- score on the CAT falls below 40). Unmanaged drug / alcohol dependence. Severe diagnosed mood or behavioral disorders that require specialize mental health interventions.

Sites / Locations

  • Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Adaptive spacing, then high-item non-adaptive spacing, then low-item non-adaptive spacing

Adaptive spacing, then low-item non-adaptive spacing, then high-item non-adaptive spacing

High-item non-adaptive spacing, then adaptive spacing, then low-item non-adaptive spacing

High-item non-adaptive spacing, then low-item non-adaptive spacing, then adaptive spacing

Low-item non-adaptive spacing, then high-item non-adaptive spacing, then adaptive spacing

Low-item non-adaptive spacing, then adaptive spacing, then high-item non-adaptive spacing

Arm Description

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.

Outcomes

Primary Outcome Measures

Change in correct responses in Confrontation Naming of Treated and Untreated Pictured Objects
Confrontation naming accuracy pictures targeted for each training condition and corresponding untreated items will serve as a primary outcome. Individualized lists for each participant will be selected from a corpus of pictured objects. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated and untreated items will serve as the primary outcome measure.
Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects
Production of trained words on the context generalization complex scene description task for each training condition and corresponding untreated items will serve as a primary outcome. Words from complex scenes and wordless picture books will be chosen for each participant. These words will consist of a subset of those selected for confrontation naming. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated and untreated items will serve as the primary outcome measure.

Secondary Outcome Measures

Mean score on the Comprehensive Aphasia Test (CAT)
The Comprehensive Aphasia Test (CAT) is a comprehensive aphasia test battery that assesses language function in the following modalities: Comprehension of Spoken Language, Comprehension of Written Language, Repetition, Naming, Reading, and Writing. The CAT will be used for initial eligibility criteria at baseline. Raw scores for each subtest are converted to T-scores (M = 50; SD = 10) based upon 266 administrations to a normative sample of 113 person with aphasia. A modality mean T-score derived from the eight modalities in the language battery is used to estimate the overall severity of aphasic language impairment. The CAT will be used to confirm a diagnosis of aphasia and determine initial eligibility criteria: participants with CAT mean modality T scores <40 will be excluded from this trial due to the severity of their deficits, as we have found this to be an appropriate cutoff for very severe aphasia in previous trials.
S-weight and P-weight scores on the Philadelphia Naming Test (PNT)
The PNT is a confrontation naming test composed of 175 high, middle, and low frequency nouns ranging from 1-4 syllables in length. Items are presented in a random order on a computer monitor and participants are asked to respond with a single word. Responses are recorded and scored offline using standardized procedures for determining accuracy of the first complete attempt and coding of errors. S-weight and P-weight are calculated based on PNT scoring. S-weight can be interpreted as a measure of semantic ability including conceptual access and control and lexical semantics. P-weight is a measure of phonological ability including both lexical and post-lexical phonological access.
Score on the Temple Assessment of Language and Short-term Memory in Aphasia (TALSA)
The TALSA is a diagnostic test battery that assesses the relationship between language and memory in people with aphasia through 16 subtests in three main areas (phonological processing, semantic processing, short-term memory). Raw scores on subtests are converted to T-scores which are used to estimate the overall severity of impairment.
Mean score on the Cactus and Camels Test (CCT)
The Cactus and Camel Test is a sub-test of the Cambridge Semantic Battery that consists of 64 items scored for accuracy of response.
Change in core lexicon analysis on the Aphasia Bank Discourse Protocol
The Aphasia Bank Discourse Protocol is a brief, but thorough set of language tasks which will characterize participants' language at the discourse level. The protocol requires participants to generate discourse samples within the contexts of free speech, a picture description, a story narrative, and procedural discourse. Change in performance in core lexicon analysis on discourse samples from initial assessment to each post-treatment follow up timepoint will serve as a secondary outcome measure.
Score on the Adapted Intrinsic Motivation Inventory for Aphasia
The adapted intrinsic motivation Inventory for aphasia is a brief instrument comprised of 7 subscales with a total of 45 items intended to characterize intrinsic motivation in people with aphasia. Each item is scored on a scale of 1-7. Higher total score is associated with higher intrinsic motivation.
Change in mean scores on the Aphasia Communication Outcome Measure Short-Form
The Aphasia Communication Outcome Measure (ACOM) is a measure of patient-reported "communication functioning," defined as the ability to effectively convey and receive personally relevant messages in natural environments. Results are provided in T scores (sample mean of 50 with a standard deviations of 10), with higher scores indicating better communication functioning.

Full Information

First Posted
December 7, 2022
Last Updated
September 26, 2023
Sponsor
University of Pittsburgh
Collaborators
University of Massachusetts, Amherst, National Institute on Deafness and Other Communication Disorders (NIDCD)
search

1. Study Identification

Unique Protocol Identification Number
NCT05653466
Brief Title
Adaptive Trial Scheduling in Naming Treatment for Aphasia
Official Title
Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (Sub-study 2: Adaptive Trial Scheduling)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2023 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
University of Massachusetts, Amherst, National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Aphasia is a language disorder caused by stroke and other acquired brain injuries that affects over two million people in the United States and which interferes with life participation and quality of life. Anomia (i.e., word- finding difficulty) is a primary frustration for people with aphasia. Picture-based naming treatments for anomia are widely used in aphasia rehabilitation, but current treatment approaches do not address the long-term retention of naming abilities and do not focus on using these naming abilities in daily life. The current research aims to evaluate novel anomia treatment approaches to improve long-term retention and generalization to everyday life. This study is one of two that are part of a larger grant. This record is for sub-study 2, which will evaluate the benefits of adaptive trial spacing.
Detailed Description
Study 2: Evaluate the benefits of adaptive trial scheduling. Study design: Investigators will enroll 32 people with aphasia in a randomized within-subjects crossover design comparing an adaptive scheduling condition to two non-adaptive conditions. Conditions will be matched for total treatment hours in a synchronous/asynchronous telehealth format designed to approximate real-world clinical practice. Participants will receive 10 weeks of computer-based training per condition, with probes administered at baseline and at 1 week, 3 months, and 6 months post-treatment. Condition order will be randomly assigned and counter-balanced across participants. In total, Study 2 will include two initial assessment sessions, 30 one-on-one treatment sessions, 96 independent practice sessions, and 24 baseline and follow-up probe sessions per participant over a 1-year period. All assessment, treatment, and probe sessions will take place via telehealth. Treatment description: For each condition, all treatment procedures will be matched except for the number of treated words and the trial spacing manipulation. The treatment phase will consist of two weeks of one-on-one treatment twice per week in which the treating clinician will ensure participants know how to use the treatment web app and complete each step of flashcard practice with complete independence, followed by 8 weeks of combined synchronous/asynchronous telepractice, in which the participant will work with the treating clinician once per week and practice an additional 4 days a week for 30 minutes a day between sessions. To carefully control dosage between treatment conditions, all independent practice sessions will be logged and proctored by a student research assistant. In-person treatment sessions will each last 45 minutes to approximate realistic treatment dosage in outpatient or home health practice settings. Treatment will consist of effortful retrieval practice: on each trial, participants will see a picture of the target and attempt to name it, then press "show answer" to see and hear the target in verbal and written form. They will then rate their naming accuracy by button press. If they are unable to name the word correctly, they will be trained to replay the answer and repeat it 3 times prior to moving on to the next trial, per Conroy et al.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Masking Description
Research assistants responsible for coding data will be masked to treatment condition.
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adaptive spacing, then high-item non-adaptive spacing, then low-item non-adaptive spacing
Arm Type
Experimental
Arm Description
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Arm Title
Adaptive spacing, then low-item non-adaptive spacing, then high-item non-adaptive spacing
Arm Type
Experimental
Arm Description
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Arm Title
High-item non-adaptive spacing, then adaptive spacing, then low-item non-adaptive spacing
Arm Type
Experimental
Arm Description
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Arm Title
High-item non-adaptive spacing, then low-item non-adaptive spacing, then adaptive spacing
Arm Type
Experimental
Arm Description
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Arm Title
Low-item non-adaptive spacing, then high-item non-adaptive spacing, then adaptive spacing
Arm Type
Experimental
Arm Description
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Arm Title
Low-item non-adaptive spacing, then adaptive spacing, then high-item non-adaptive spacing
Arm Type
Experimental
Arm Description
All participants will receive all three naming treatment conditions in a randomized order - this is one possible ordering of those conditions.
Intervention Type
Behavioral
Intervention Name(s)
Adaptive Spacing Condition
Intervention Description
Each of the 200 target words for practice are presented on a schedule determined by an algorithm that relies on the pattern of correct vs. incorrect responses for each item. Items in the "active learning" state need to be answered correctly a certain number of times before being categorized as "learned." Each item must be answered correctly 3 times in a row (immediately, then at one-minute and five-minute intervals) before it is categorized as "learned." Then, it will be scheduled at ever-increasing intervals, until answered incorrectly, at which point the item would be returned to the "active learning" state, requiring three correct responses in a row to return again to the "learned" expanding interval state.
Intervention Type
Behavioral
Intervention Name(s)
High-Item Non-Adaptive Spacing Condition
Intervention Description
Each of the 200 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.
Intervention Type
Behavioral
Intervention Name(s)
Low-Item Non-Adaptive Spacing Condition
Intervention Description
Each of the 40 target words for practice are presented in sequential order randomized within blocks, with each word presented once before the list repeats.
Primary Outcome Measure Information:
Title
Change in correct responses in Confrontation Naming of Treated and Untreated Pictured Objects
Description
Confrontation naming accuracy pictures targeted for each training condition and corresponding untreated items will serve as a primary outcome. Individualized lists for each participant will be selected from a corpus of pictured objects. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated and untreated items will serve as the primary outcome measure.
Time Frame
Initial assessment (pre-treatment), 3 months post-treatment
Title
Change in correct responses in Context Generalization of Treated and Untreated Pictured Objects
Description
Production of trained words on the context generalization complex scene description task for each training condition and corresponding untreated items will serve as a primary outcome. Words from complex scenes and wordless picture books will be chosen for each participant. These words will consist of a subset of those selected for confrontation naming. Performance will be evaluated twice at each timepoint. Change in performance from initial assessment to the 3-month follow-up timepoint on the treated and untreated items will serve as the primary outcome measure.
Time Frame
Initial assessment (pre-treatment), 3 months post-treatment
Secondary Outcome Measure Information:
Title
Mean score on the Comprehensive Aphasia Test (CAT)
Description
The Comprehensive Aphasia Test (CAT) is a comprehensive aphasia test battery that assesses language function in the following modalities: Comprehension of Spoken Language, Comprehension of Written Language, Repetition, Naming, Reading, and Writing. The CAT will be used for initial eligibility criteria at baseline. Raw scores for each subtest are converted to T-scores (M = 50; SD = 10) based upon 266 administrations to a normative sample of 113 person with aphasia. A modality mean T-score derived from the eight modalities in the language battery is used to estimate the overall severity of aphasic language impairment. The CAT will be used to confirm a diagnosis of aphasia and determine initial eligibility criteria: participants with CAT mean modality T scores <40 will be excluded from this trial due to the severity of their deficits, as we have found this to be an appropriate cutoff for very severe aphasia in previous trials.
Time Frame
Initial assessment (pre-treatment)
Title
S-weight and P-weight scores on the Philadelphia Naming Test (PNT)
Description
The PNT is a confrontation naming test composed of 175 high, middle, and low frequency nouns ranging from 1-4 syllables in length. Items are presented in a random order on a computer monitor and participants are asked to respond with a single word. Responses are recorded and scored offline using standardized procedures for determining accuracy of the first complete attempt and coding of errors. S-weight and P-weight are calculated based on PNT scoring. S-weight can be interpreted as a measure of semantic ability including conceptual access and control and lexical semantics. P-weight is a measure of phonological ability including both lexical and post-lexical phonological access.
Time Frame
Initial assessment (pre-treatment)
Title
Score on the Temple Assessment of Language and Short-term Memory in Aphasia (TALSA)
Description
The TALSA is a diagnostic test battery that assesses the relationship between language and memory in people with aphasia through 16 subtests in three main areas (phonological processing, semantic processing, short-term memory). Raw scores on subtests are converted to T-scores which are used to estimate the overall severity of impairment.
Time Frame
Initial assessment (pre-treatment)
Title
Mean score on the Cactus and Camels Test (CCT)
Description
The Cactus and Camel Test is a sub-test of the Cambridge Semantic Battery that consists of 64 items scored for accuracy of response.
Time Frame
Initial assessment (pre-treatment)
Title
Change in core lexicon analysis on the Aphasia Bank Discourse Protocol
Description
The Aphasia Bank Discourse Protocol is a brief, but thorough set of language tasks which will characterize participants' language at the discourse level. The protocol requires participants to generate discourse samples within the contexts of free speech, a picture description, a story narrative, and procedural discourse. Change in performance in core lexicon analysis on discourse samples from initial assessment to each post-treatment follow up timepoint will serve as a secondary outcome measure.
Time Frame
Initial assessment (pre-treatment), multiple timepoints up to 6-months post-treatment.
Title
Score on the Adapted Intrinsic Motivation Inventory for Aphasia
Description
The adapted intrinsic motivation Inventory for aphasia is a brief instrument comprised of 7 subscales with a total of 45 items intended to characterize intrinsic motivation in people with aphasia. Each item is scored on a scale of 1-7. Higher total score is associated with higher intrinsic motivation.
Time Frame
Initial assessment (pre-treatment)
Title
Change in mean scores on the Aphasia Communication Outcome Measure Short-Form
Description
The Aphasia Communication Outcome Measure (ACOM) is a measure of patient-reported "communication functioning," defined as the ability to effectively convey and receive personally relevant messages in natural environments. Results are provided in T scores (sample mean of 50 with a standard deviations of 10), with higher scores indicating better communication functioning.
Time Frame
Initial assessment (pre-treatment), 1 week post-treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Existing diagnosis of chronic (>6 months) aphasia subsequent to left hemisphere stroke. Impaired performance on 2/8 sections of the Comprehensive Aphasia Test. Must have access to a high-speed internet connection and be able to participate in telehealth. Exclusion Criteria: History of other acquired or progressive neurological disease. Significant language comprehension impairments (per performance on the CAT - individuals will be excluded if their spoken language comprehension mean modality T- score on the CAT falls below 40). Unmanaged drug / alcohol dependence. Severe diagnosed mood or behavioral disorders that require specialize mental health interventions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aysha Salter-Volz, M.S.
Phone
412-383-6943
Email
ays41@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Evans, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Evans, PhD
Phone
412-383-6943
Email
will.evans@pitt.edu
First Name & Middle Initial & Last Name & Degree
William Evans, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing plan for this study includes the publication of discourse measures and other study data on Aphasia Bank (R01-DC008524), a large online repository of aphasia behavioral data that supports a great deal of productive aphasia corpora research. De-identified test scores, treatment, and probe data, and audio and/or video recordings of norming, probe, assessment, and treatment data will be shared to this repository for all study participants. Investigators will also make our experimental task files, protocols, and de-identified study data available through Open Science Framework (https://osf.io/) to encourage the replication, collaboration, and expansion of our work by other research groups. Last, investigators plan to publish a modeling and statistical package in open-access software, R, which will include functionality for calculating speed-accuracy tradeoff optimality using our multinomial ex-Gaussian response time model approach.
IPD Sharing Time Frame
Data will be shared at the time of study publication without planned end to access.
IPD Sharing Access Criteria
Anyone who wishes to access the data.

Learn more about this trial

Adaptive Trial Scheduling in Naming Treatment for Aphasia

We'll reach out to this number within 24 hrs