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Clinical Trials/NCT05653466
NCT05653466
Recruiting
Phase 2

Integrating Complementary Learning Principles in Aphasia Rehabilitation Via Adaptive Modeling (Sub-study 2: Adaptive Trial Scheduling)

University of Pittsburgh1 site in 1 country32 target enrollmentDecember 6, 2023
ConditionsAphasiaStroke

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Aphasia
Sponsor
University of Pittsburgh
Enrollment
32
Locations
1
Primary Endpoint
Change in correct responses in Confrontation Naming of Treated and Untreated Pictured Objects
Status
Recruiting
Last Updated
4 months ago

Overview

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. For each condition, all treatment procedures will be matched except for the number of treated words and the trial spacing manipulation. 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 typically 3-4 (but up to 6) assessment sessions, 120 one-on-one treatment sessions, and 24 baseline and follow-up probe sessions per participant over an \~1-year period, or up to 18 months. 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 for each of the three conditions will consist of ten weeks of one-on-one treatment four times per week in which the treating clinician will work alongside participants to complete flashcard practice four days a week. The treatment sessions will each last 30 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 rate their naming accuracy by button press. The experimenter will code their response time and perceived accuracy. Finally, the experimenter will code their accuracy which will reveal the target in verbal and written form. If they are unable to name the word correctly, they will be able to replay the answer and repeat it three times prior to moving on to the next trial, per Conroy et al.

Registry
clinicaltrials.gov
Start Date
December 6, 2023
End Date
January 31, 2028
Last Updated
4 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

William Evans

Assistant Professor

University of Pittsburgh

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
  • Unmanaged drug / alcohol dependence.
  • Severe diagnosed mood or behavioral disorders that require specialize mental health interventions.

Outcomes

Primary Outcomes

Change in correct responses in Confrontation Naming of Treated and Untreated Pictured Objects

Time Frame: Initial assessment (pre-treatment), 3 months post-treatment

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

Time Frame: Initial assessment (pre-treatment), 3 months post-treatment

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 Outcomes

  • Change in core lexicon analysis on the Aphasia Bank Discourse Protocol(Initial assessment (pre-treatment), 3 months post-treatment)
  • Change in mean scores on the Aphasia Communication Outcome Measure Short-Form(Initial assessment (pre-treatment), 1 week post-treatment.)
  • Score on the Adapted Intrinsic Motivation Inventory for Aphasia(1 week post-treatment)

Study Sites (1)

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