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临床试验/NCT04289493
NCT04289493已完成不适用

DUbbing Language-therapy CINEma-based in Aphasia Post-Stroke (DULCINEA). A Feasibility Cross-over Pilot-trial

Instituto de Investigación Hospital Universitario La Paz2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Communicative Activity Log (CAL) questionnaire

研究概览

简要总结

The DULCINEA study aims to develop and validate a new therapy that integrates essential language characteristics and functional communication by dubbing scenes from television series that represent daily situations. It will be a randomized, crossed over, interventional pilot study recruiting 54 patients with poststroke nonfluent aphasia. Patients will be treated individually in 40-minute sessions twice a week for 8 weeks. In each session, a speech therapist and an actor will select the clips with muted words or sentences that have been detected as functionally meaningful for each patient. Outcomes will be assessed as significant differences in two aphasia tests.

详细描述

The DULCINEA study aims to develop and validate a new therapy that integrates essential language characteristics and functional communication by dubbing scenes from TV series that represent daily situations. It will be a randomized, crossed over, interventional pilot study recruiting 54 patients with poststroke nonfluent aphasia from the departments of Neurology and Rehabilitation from La Paz University Hospital and also from the "Afasia Activa" association. After meeting all inclusion and none of the exclusion criteria and signing informed consent, patients will be randomised (1:1) in two different treatment groups. The first group will receive therapy within the first 3 months of their inclusion with a subsequent period of another 3 months without therapy (thus, serving as group 2 controls). Group 2 will initiate therapy after 3 months since their inclusion (serving as group 1 controls during the first 3 months). Therapy consists of 17 sessions performed in a eight week period (1 baseline session and 16 dubbing sessions), each lasting 40 minutes, in which the patient will be asked to dubb words or sentences previously selected and considered as functionally meaningful for them. These words will be chosen through an online survey performed by a representative group of aphasic patients and the study patients´own relatives in the baseline treatment session. Outcomes will be assessed as significant differences in two aphasia tests (CAL questionnaire and the BDAE).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

A psychologist blinded to the patient´s clinical characteristics and study groups performs the outcome questionnaires three times for each patient during the study period.

入排标准

性别
All
接受健康志愿者

入选标准

  • nonfluent aphasia due to unilateral stroke in the left hemisphere without neuroimaging evidence of lesions in the right hemisphere.
  • the patient should have received a standard program of conventional speech therapy after stroke, remaining with aphasia with the following characteristics: severely restricted language, poor repetition (even for single words), not exceeding the 70th percentile in the Boston Diagnostic Aphasia Examination (BDAE) for repetition. Moderately preserved language comprehension: listening comprehension exceeding the 15th percentile of BDAE (average score obtained in three areas: word comprehension, commands and complex ideational material).
  • Signed informed consent.

排除标准

  • Any clinical condition (short life expectancy, coexisting disease) or other characteristics that precluded appropriate follow-up.
  • Participation in any therapeutic trial evaluating poststroke recovery.

结局指标

主要结局

Communicative Activity Log (CAL) questionnaire

时间窗: Changes in score at six months

Questionnaire that evaluates quantity and quality of aphasic patient communication, with 18 different questions in each item. Each question belonging to these two items is answered as a 6 point scale, where 0 is the worst and 5 is the best score.

Boston Diagnostic Aphasia Examination (BDAE)

时间窗: Changes in score at six months

Neuropsycological battery that evaluates language skills based on perceptual modalities (auditory, visual, and gestural), processing functions (comprehension, analysis, problem-solving), and response modalities (writing, articulation, and manipulation). There are five subtests which include: conversational and expository speech, auditory comprehension, oral expression, reading, and writing. Its results can be used to classify patient's language profiles into one of the localization based classifications of aphasia, and it also provides a severity rating.

次要结局

  • Stroke and aphasia Quality of Life Scale (SAQOL-39)(Changes in score at six months)
  • Western Aphasia Battery Revised (WAB-R)(Changes in score at six months)
  • Stroke Aphasic Depression Questionnaire (SADQ10)(Changes in score at six months)
  • General Health Questionnaire (GQH-12)(Changes in score at six months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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