Primary Progressive Aphasia Multicomponent Language Treatment Study

Официальное название

Establishing Evidence-based Multicomponent Treatment for Speech and Language in Primary Progressive Aphasia

Обзор

The goal of this clinical trial is to learn if a speech-language telerehabilitation helps improve communication in people with primary progressive aphasia (PPA), a form of dementia that affects speech and language. The study will also document how acceptable and helpful the program is for both patients and their care partners. The main questions the study aims to answer are: 1. Is the telerehabilitation program feasible and acceptable for people with PPA and their care partners? 2. Do participants with PPA and care partners report satisfaction with the program? 3. Which outcome measures are most useful for evaluating changes in communication and quality of life? 4. What patterns of treatment response are seen in participants after completing the program? Researchers will test the program in a small group of participants to see how people respond. The program includes both speech-language therapy and training for care partners. Participants will: * Take part in online speech-language therapy sessions * Complete communication tasks and questionnaires before and after the program * Have regular virtual check-ins with the research team * Include their care partners in some parts of the program for training and support

Вмешательства

• Поведенческое Multicomponent Lexical Retrieval Training (Multi-LRT)
  In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions. Participants work on producing names of personally relevant target in multiple communication modalities. Treatment focuses on the use of strategies which capitalize on residual linguistic ability and autobiographical memory to support word retrieval. The participant completes two one-hour-long sessions per week plus daily homework. The participant
• Поведенческое Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA)
  In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions. Participants work on producing personally relevant scripts of 3-5 sentences in length. Length and complexity of scripts are individually tailored. The participant completes 30 minutes per day of home practice, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts. Biweekly (one hour each)
• Поведенческое Multicomponent Communication Partner Training (Multi-CPT)
  In person or via teletherapy: A multi-component treatment incorporating elements of compensatory and care-partner focused interventions. Biweekly (one hour each) sessions with a clinician are held which target use of communication strategies including multimodal communication for the participant and study partner (e.g., spouse). The participant also completes regular assignments meant to increase generalization of communication strategies and progress on personal goals.

Первичные конечные точки

• Change in script production accuracy [Срок оценки: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment]
• Change in spoken naming of trained/untrained items [Срок оценки: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment]
• Information communicated in any modality for trained/untrained stimuli [Срок оценки: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment]
• Goal Attainment Score [Срок оценки: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment]

Вторичные конечные точки (2)

• Change on Quick Aphasia Battery [Срок оценки: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment]
• Change on Aphasia Impact Questionnaire [Срок оценки: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment]

Критерии участия

Критерии включения

• Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)
• Scores of 10 or higher on the Mini-Mental State Examination
• Has a study partner who can consistently attend sessions

Критерии исключения

• Other neurological or psychiatric diagnosis that may contribute to cognitive-linguistic deficits
• Significant, uncorrected visual or hearing impairment that would interfere with participation
• Score of less than 10 on the Mini-Mental State Examination
• Prominent initial non-speech-language impairment (cognitive, behavioral, motoric)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Texas — Austin

Идентификаторы

NCT: NCT06649084 · R56DC016291 · R56DC016291

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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