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临床试验/NCT01979159
NCT01979159已完成不适用

A Novel Treatment for Aphasia and Apraxia of Speech: Measurement of Outcomes

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2013年10月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Change in Production of Language Content for Untreated Sets - Generalization Measured in Effect Sizes

研究概览

简要总结

In order to determine if speech-language therapy has positive effect, reliable measurement tools are required to document outcomes. Currently, there is very limited information concerning the measurement of changes in speech production as a result of treatment for acquired apraxia of speech and aphasia. This study will obtain information concerning the reliability of several speech production measures over time. Thirty persons with chronic aphasia and apraxia of speech will be asked to provide speech samples in response to commonly used assessment tools on three sampling occasions so that the stability of measurements may be examined.

After establishment of appropriate outcome measures, a small, pilot treatment study will be conducted with four participants. The participants will receive a new treatment for aphasia and acquired apraxia of speech and outcomes will be measured relative to speech and language production.

详细描述

A single group, repeated measures design will be used to obtain repeated speech samples from 30 persons with chronic acquired apraxia of speech and aphasia. Speech samples will be elicited using commonly employed motor speech assessment protocols; an initial sample, a sample one week following the initial sample, and a sample at four weeks following the initial sample. The following measures will be obtained from the samples: percent consonants correct, percent fluent utterances, and duration of utterance. Stability of the measures will be examined.

After the preceding measures have been analyzed, a series of four, single-subject experimental designs will be conducted. Four participants with chronic aphasia and apraxia of speech will receive a new treatment for aphasia and apraxia of speech applied sequentially to two sets of experimental picture picture stimuli. Outcomes will be measured in terms of speech production (measures described above) as well as in terms of language production.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Veterans or non Veterans with aphasia and apraxia of speech who reside in the Salt Lake City region (commutable),
  • 12 months or more post stroke or other focal brain injury, no other neurological conditions,
  • native English speakers, hearing adequate for experimental task (e.g., pass puretone screening at 35dB at 500, 1K, 2K Hz),
  • non linguistic cognition within normal limits

排除标准

  • less than 12 months post stroke,
  • insufficient hearing, insufficient non linguistic cognitive skills,
  • neurological conditions other than stroke,
  • more than one stroke or brain injury
  • unable to attend treatment in the Salt Lake City vicinity

研究组 & 干预措施

Combined Aphasia-ApraxiaTreatment

Experimental

Administration of Combined Aphasia and Apraxia of Speech Treatment )(CAAST) to 4 persons with aphasia and apraxia of speech in the context of single-subject designs

干预措施: Combined Aphasia and Apraxia of Speech Treatment (CAAST) (Behavioral)

结局指标

主要结局

Change in Production of Language Content for Untreated Sets - Generalization Measured in Effect Sizes

时间窗: baseline (prior to treatment) through follow-up at 6 weeks post treatment

Correct Information Units (CIUs) is a measure of the amount of relevant content produced in connected language tallied according to operationalized criteria. CIU is not a test or scale - it is a measure that is applied to language samples - in this case, description of untreated pictures. Participants described experimental pictures, responses were transcribed and CIUs counted. CIUs can range from 0 to an unlimited maximum. Effect sizes (ESs) were calculated as an indication of the magnitude of change in number of CIUs produced (pre treatment to post treatment. ESs can range from negative (poorer performance post-treatment) to positive values (better performance post-treatment), with larger positive values reflecting greater gains. Benchmarks are as follows: \>9.53 = large, 9.52 - 5.52 = medium, 6.55 - 3.29 = small, \<3.29 = negligible. Small to large ESs indicate production of measurably more CIUs in picture descriptions post-treatment. Larger the ES, the greater the change.

Change in Language Content Production for Treated Stimuli: Effect Sizes (Magnitude of Change From Baseline to Follow-up)

时间窗: Following completion of treatment at 6 weeks post

Correct Information Units (CIUs) is a measure of the amount of relevant content produced in connected language tallied according to operationalized criteria. CIU is not a test or scale - it is a measure that is applied to language samples - in this case, description of treated pictures. Participants described experimental pictures, responses were transcribed and CIUs counted. CIUs can range from 0 to an unlimited maximum. Effect sizes (ESs) were calculated as an indication of the magnitude of change in number of CIUs produced (pre treatment to post treatment. ESs can range from negative (poorer performance post-treatment) to positive values (better performance post-treatment), with larger positive values reflecting greater gains. Benchmarks are as follows: \>11.14 = large, 11.13 - 6.56 = medium, 6.55 - 3.88 = small, \<3.88 = negligible. Small to large ESs indicate production of measurably more CIUs in picture descriptions post-treatment. Larger the ES, the greater the change.

次要结局

  • Changes in Speech Intelligibility on the Assessment of Intelligibility of Dysarthric Speech(pre and post treatment - prior to the start of treatment and at 6 weeks following the completion of treatment)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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