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临床试验/NCT06649084
NCT06649084Enrolling By Invitation不适用

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

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
21
试验地点
2
主要终点
Change in script production accuracy

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Change in script production accuracy

时间窗: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment

Percent correct intelligible, scripted words for trained/untrained scripts

Change in spoken naming of trained/untrained items

时间窗: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment

Percent correctly named trained/untrained pictures

Information communicated in any modality for trained/untrained stimuli

时间窗: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment

Percent of major content units (key words) communicated via speech or nonspeech modalities (e.g., writing, drawing, gesture) for trained/untrained scripts (Multi-VISTA) or words (Multi-LRT) during structured probes and in conversation

Goal Attainment Score

时间窗: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment

The Goal Attainment Score is self-reported progress on personalized goals based on a five point scale.

次要结局

  • Change on Quick Aphasia Battery(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(change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maya Henry

Associate Professor

University of Texas at Austin

研究点 (2)

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