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临床试验/NCT03699605
NCT03699605已完成不适用

Development and Feasibility Analysis of Verbal Expressive Skills Management Programme (VESMP) for Patients With Broca Aphasia

Isra University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年11月2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
50
试验地点
1
主要终点
Stroke Quality of life Scale

研究概览

简要总结

The present study was conducted to develop the verbal expressive skills management programme (VESMP) to enhance verbal expressive skills of patients with severe Broca aphasia. To determine the efficacy of VESMP in improving the quality of life and level of satisfaction of aphasic stroke patients.Control group received traditional therapy and experimental group received therapy through VESMP programme on their smart phones.

详细描述

Speech therapy makes an integral part of the non-pharmacological, conservative management of Post stroke aphasia. Routine speech therapy aims to improve comprehension and verbal skills and also develop functional communication skills through augmentative Alternative communication devices. Disorders of communication, including aphasia (mainly post stroke) caused by the left hemisphere brain damage, is a major community health issue. Aphasia is a language disorder occurring mainly as a result of stroke. It is an acquired impairment of language that weakens people's ability of comprehension and expression, it does not show any affect to intellect ability. The verbal expressive skills management programme (VESMP) is the software which developed augmented management for patients to enhance verbal expressive skills for patients with severe Broca's aphasia from different geographic areas.

研究设计

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

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The 40-60 year Broca aphasia patients
  • •The severe Broca aphasia patients (more than 03 month of onset of stroke) Both infarct and hemorrhagic stroke
  • •Either gender Informed consent

排除标准

  • •• Broca Aphasic patients having cognitive impairment
  • •The patients having tumors, infections and trauma

研究组 & 干预措施

VESMP

Experimental

Participants used VESMP at least half hour session thrice a week over an average of 4 months. The instruction before every domain included using it independently on the participant's own smart phone, or with a trained person either in the clinic or on their phone brought to the participant's home.

Total 25 patients with diagnosis of severe non-fluent aphasia included, ages 40+, at least 3 months post-onset of single unilateral CVA affecting the language dominant hemisphere at the time of baseline testing also including, Participant demographics, aphasia classification and severity. All subjects participated in an intensive 2-week VESMP treatment program prior to beginning the individualized programs.

干预措施: VESMP (Other)

Traditional Therapy

Active Comparator

Control group received traditional therapy total 25 patients with diagnosis of severe non-fluent aphasia included, All subjects participated in an traditional therapy group in routine and received language therapy for 4 months of periods with three sessions per week.

干预措施: Traditional Therapy (Other)

结局指标

主要结局

Stroke Quality of life Scale

时间窗: 16 weeks

Scoring: each item shall be scored with the following key Total help - Couldn't do it at all - Strongly agree 1 A lot of help - A lot of trouble - Moderately agree 2 Some help - Some trouble - Neither agree nor disagree 3 A little help - A little trouble - Moderately disagree 4 No help needed - No trouble at all - Strongly disagree 5

Boston Diagnostic Aphasia Examination Battery (BDAE)

时间窗: 16 weeks

The Boston Diagnostic Aphasia Examination Battery (BDAE) was administered to all participants pre-and post-VESMP. The BDAE is a comprehensive standardized test of language performance for individuals with aphasia that includes measures of spoken language, naming, auditory comprehension, reading and other modalities.

次要结局

未报告次要终点

研究者

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

Humaira Shamim

Assistant Professor

Riphah International University

研究点 (1)

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