ECoLoGiC Speech Therapy for Everyday Communication in Aphasia

NCT06132464 | Completed

• 2 other identifiers: STUDY149823UL1TR002366
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this clinical trial study is to evaluate the effect of a new therapy to improve talking in people with the language disability 'aphasia' after a stroke. The therapy is called: 'Expanding Communication and Language Generated in Conversation Treatment' (ECoLoGiC Treatment), and helps improve language skills for talking to other people in conversation. The second goal is to develop training materials to teach families of people with aphasia about the therapy and how to practice at home. This part of the study will be completed with help from two people with aphasia and a family member who have completed the program. The study asks:

1. 1.How do people with aphasia improve their language skills following this therapy? Results will be determined by using tests of language and by testing language in conversation and other types of talking tasks, like describing a picture.
2. 2.After completing the family training, do family members use the ideas they learned when talking to the person with aphasia? And, what do family members and people with aphasia think of the family training? The first question will be answered with a checklist to see if the family members followed the ideas they learned. The second question will be answered by talking with the people with aphasia and the family members to find out what they thought.

Conditions

Aphasia

Keywords

Aphasia; Stroke; Discourse; Conversation; Communication

Outcome Measures

Primary Outcomes (6)

• Change on the Western Aphasia Battery - Revised, part 1 Auditory and Verbal Subtests: yields Aphasia Quotient Score

  Change on the 100-point Aphasia Quotient score indicating severity of speaking and auditory comprehension skills in aphasia between Post-Treatment and Pre-Treatment; and 6-Week Maintenance and Pre-Treatment. Lower scores indicate greater severity of aphasia. Score change which indicates the criterion for change varies based on the participant's Pre-Treatment Aphasia Quotient score.

  Baseline; Weeks 1-2 (Pre-Treatment); Weeks 13-14 (Post-Treatment); Weeks 19-20 (6-Week Maintenance)

• Change on the Communication Activities of Daily Living - 3

  Change in the score of functional everyday communication skills (i.e., ordering in a restaurant, reading signs, making a phone call) between Post-Treatment and Pre-Treatment; and 6-Week Maintenance and Pre-Treatment on 100 point test. Higher scores indicate higher level of function. Score change interpreted per examiner's manual, \> standard error of measurement = 4 points .

  Baseline; Weeks 1-2 (Pre-Treatment); Weeks 13-14 (Post-Treatment); Weeks 19-20 (6-Week Maintenance)

• Change on Communicative Success of verbal and nonverbal communication in Conversation

  Change in average score for successfulness communicating using verbal and nonverbal methods, on the measure's 4-point scale (4 is highest level of function), between Post-Treatment and Pre-Treatment; and 6-Week Maintenance and Pre-Treatment. Score change interpreted for effect size and whether average score change exceeds minimal detectable change criterion (i.e., .14 points).

  Baseline; Weeks 1-2 (Pre-Treatment); Weeks 13-14 (Post-Treatment); Weeks 19-20 (6-Week Maintenance)

• Change on Global Coherence of sentences to the topic in Conversation

  Change in average score for extent of coherence of sentences produced to the topic being discussed, on the measure's 4-point scale (4 is highest level of function), between Post-Treatment and Pre-Treatment; and 6-Week Maintenance and Pre-Treatment. Score change interpreted for effect size and whether average score change exceeds minimal detectable change criterion (i.e., .14 points).

  Baseline; Weeks 1-2 (Pre-Treatment); Weeks 13-14 (Post-Treatment); Weeks 19-20 (6-Week Maintenance)

• Change on Assessment for Living with Aphasia - 2 (Patient-Reported Outcome Measure)

  Change in overall score of self-perceptions of the impact of aphasia on daily life, activities, communication, emotions with a maximum score of 148 (148 is highest level of function), between Post-Treatment and Pre-Treatment; and 6-Week Maintenance and Pre-Treatment. Criterion for score change, \> 10%.

  Baseline; Weeks 1-2 (Pre-Treatment); Weeks 13-14 (Post-Treatment); Weeks 19-20 (6-Week Maintenance)

• Change on American Speech Language Hearing Association: Functional Assessment of Communication Skills for Adults (Family-Reported Outcome Measure)

  Change in overall score of family member perceptions of the person with aphasia's communication skills, on the measure's 7-point scale (1-7; 7 is highest level of function), between Post-Treatment and Pre-Treatment; and 6-Week Maintenance and Pre-Treatment. Criterion for score change, \> 10%.

  Baseline; Weeks 1-2 (Pre-Treatment); Weeks 13-14 (Post-Treatment); Weeks 19-20 (6-Week Maintenance)

Secondary Outcomes (19)

• Change on Western Aphasia Battery - Revised, part 2, Reading and Writing Subtests

  Baseline; Weeks 1-2 (Pre-Treatment); Weeks 13-14 (Post-Treatment); Weeks 19-20 (6-Week Maintenance)

• Change on Object and Action Naming Battery

  Baseline; Weeks 1-2 (Pre-Treatment); Weeks 13-14 (Post-Treatment); Weeks 19-20 (6-Week Maintenance)

• Change on Northwestern Assessment of Verbs and Sentences, Adapted (pictures like "a dog is barking" are used to elicit sentences. Standard version provides the verb; adapted version does not; Edmonds et al., 2009; Leaman & Edmonds, 2022).

  Baseline; Weeks 1-2 (Pre-Treatment); Weeks 13-14 (Post-Treatment); Weeks 19-20 (6-Week Maintenance)

• Change on Communication Confidence Rating Scale (Patient-Reported Outcome Measure)

  Baseline; Weeks 1-2 (Pre-Treatment); Weeks 13-14 (Post-Treatment); Weeks 19-20 (6-Week Maintenance)

• Change on Communicative Effectiveness Index (Family-Reported Outcome Measure)

  Baseline; Weeks 1-2 (Pre-Treatment); Weeks 13-14 (Post-Treatment); Weeks 19-20 (6-Week Maintenance)

Study Arms (1)

Expanding Communication and Language Generated in Conversation Treatment

EXPERIMENTAL

Participants will complete 20 one-hour therapy sessions over 10 weeks with an experienced, trained, and licensed speech-language pathologist delivering Expanding Communication and Language Generated in Conversation Therapy, following the therapy protocol. Sessions will take place through casual conversational interactions, with incremental problem-solving and communication support by the speech-language pathologist.

Behavioral: Expanding Communication and Language Generated in Conversation Treatment

Interventions

Expanding Communication and Language Generated in Conversation Treatment BEHAVIORAL

ECoLoGiC Treatment is a behavioral therapy developed to improve language abilities in everyday conversation for people with aphasia. It is delivered through therapeutic use of spontaneous conversational interactions between a speech-language pathologist and a person with aphasia. ECoLoGiC Treatment is based on theories of conversational interaction in adults without communication disorders, as well as on theories of neuroplasticity, rehabilitation, and learning. The therapy consists of two components: a) Therapeutic Conversation, during which the pair discuss any topic of interest to the person with aphasia, while the speech-language pathologist uses techniques to promote social interaction; and b) Therapeutic Repair, used when communication breakdown occurs. At this time, the speech-language pathologist implements the intervention's 7-step least-to-most hierarchy, supporting the person's independence and learning in communicative problem-solving to communicate the desired idea.

Expanding Communication and Language Generated in Conversation Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85 years
• Self-reported adequate vision (aided), for testing procedures
• Pass a hearing screening (aided), in at least one ear at 40 decibels at 1000 Herz
• Monolingual speaker of English
• One or more left hemisphere stroke at least 6 months prior, leading to aphasia
• Right-handed prior to stroke
• Moderate to severe aphasia, as evaluated by the Western Aphasia Battery - Revised and clinical expertise
• Spoken language production of at least 2-3 word utterances (phrases or sentences), as evaluated by the Western Aphasia Battery - Revised and clinical expertise
• Reading comprehension of at least single words to short phrases, as evaluated by the Western Aphasia Battery - Revised and clinical expertise,
• Auditory comprehension for simple language, as evaluated by the Western Aphasia Battery - Revised and clinical expertise

You may not qualify if:

• Younger than 18
• Older than 85
• Self-reported vision impairment preventing completion of testing (aided)
• Unable to pass hearing screening in at least one ear at 40 decibels at 1000 Herz (aided)
• Multilingual speaker (language proficiency of greater than 4 out of 7 on reading, writing, speaking, or listening in any language other than English; self-rating bilingualism scale)
• Minimal, mild, or profound aphasia as evaluated by the Western Aphasia Battery - Revised and clinical expertise
• Severe cognitive impairment as evaluated by the Cognitive Linguistic Quick Test - Plus and clinical expertise
• No greater than a score of 2.5 on the Apraxia of Speech Rating Scale
• No greater than 3.0 on the Dysarthria-in-Interaction Profile
• Use of an alternative augmentative communication device as primary means of communication
• Spoken language production consisting of single word or no verbal communication, as evaluated by the Western Aphasia Battery - Revised and clinical expertise
• Inability to comprehend simple language in conversation, as evaluated by the Western Aphasia Battery - Revised and clinical expertise
• Inability to read single words for comprehension, as evaluated by the Western Aphasia Battery - Revised and clinical expertise
• Neurological injury or condition other than left hemisphere stroke
• Left-handed before stroke

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Aphasia; Stroke; Communication

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Marion Leaman, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 15, 2023
• Study Start: January 3, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)