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临床试验/NCT02768922
NCT02768922已完成不适用

Aphasia Telerehabilitation Post Stroke

Sunnaas Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2016年5月3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
发起方
入组人数
62
试验地点
2
主要终点
Naming ability assessed by NGA

研究概览

简要总结

This study aims at contributing with scientific evidence to the field of aphasia telerehabilitation. In Norway today, there is an unmet need for language training in post stroke aphasia and not all patients are offered language training. Early start of aphasia rehabilitation and satisfying intensity do not seem to be standard clinical practice. Language training by telemedicine could improve this situation, and this study seeks to answer the question whether aphasia rehabilitation delivered by videoconference can improve language function in aphasia post stroke.

详细描述

BACKGROUND:

About 25 % of all stroke cases lead to aphasia. Aphasia can include difficulties with speech production and comprehension, as well as reading and writing impairment. Language impairment affects post stroke rehabilitation in a negative manner. Quality of life is reduced in persons with aphasia compared to stroke victims without aphasia. Speech and language therapy is the main form of aphasia rehabilitation. The most updated Cochrane review indicates that intensive speech and language therapy is more effective than therapy of lower intensity. Current aphasia services in Norway do not seem to be in accordance with the national guidelines for treatment and rehabilitation of stroke. The capacity for aphasia rehabilitation at the community level is too small and there is a lack of speech -language pathologists (SLPs). Language training by videoconference could improve this unmet need for language training in post stroke aphasia. The literature within this field is however sparse and there is a substantial lack of studies showing the effectiveness of telerehabilitation. Financed by the Norwegian Foundation for Health and Rehabilitation, the investigators have earlier performed a feasibility study at Sunnaas Rehabilitation Hospital in cooperation with the Norwegian Centre for Integrated Care and Telemedicine. This feasibility study showed that language training by videoconference is feasible with regard to technical, practical and rehabilitation aspects. The feasibility study laid ground for a larger and controlled study.

OBJECTIVE:

The project aims at contributing with scientific evidence to the field of aphasia telerehabilitation. The objective of this randomized controlled clinical trial is to investigate the feasibility and effectiveness of speech and language training given by videoconference.

DESIGN:

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
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with aphasia following stroke (all stages of aphasia post stroke)
  • Aphasia including naming impairment (percentile score of 70 or lower on the NGA - subtest naming)

排除标准

  • Age: < 16 years
  • Patients who are unable to perform 5 hours of speech and language therapy per week due to medical or cognitive reasons (Including vision and hearing impairment)

研究组 & 干预措施

Aphasia telerehabilitation

Experimental

Speech and language therapy is given by telemedicine to improve expressive language function. The therapy will include knowledge based tasks of aphasia rehabilitation including training of language forms and overall functional communication. A special emphasis will be put on naming training. The telerehabilitation will be given in a addition to standard face-to-face aphasia rehabilitation

干预措施: Aphasia telerehabilitation (Other)

Aphasia telerehabilitation

Experimental

Speech and language therapy is given by telemedicine to improve expressive language function. The therapy will include knowledge based tasks of aphasia rehabilitation including training of language forms and overall functional communication. A special emphasis will be put on naming training. The telerehabilitation will be given in a addition to standard face-to-face aphasia rehabilitation

干预措施: Standard face-to-face aphasia rehabilitation (Other)

Control

Active Comparator

Control Group receives standard face-to-face aphasia rehabilitation

干预措施: Standard face-to-face aphasia rehabilitation (Other)

结局指标

主要结局

Naming ability assessed by NGA

时间窗: four month post randomization

Will be assessed by the Norwegian Basic Aphasia Assessment (NGA) subtest "naming"

次要结局

  • Repetition immediately after intervention assessed by NGA(immediately after intervention (4 weeks))
  • Experiences of patients with the telerehabilitation by questionnaire(four month post randomization)
  • Experiences of SLPs with the telerehabilitation by semi-structured interviews(through study completion, an average of 2 year)
  • Quality of life assessed by SAQOL-39.(four month post randomization)
  • Language function other than naming (repetition) assessed by NGA(four month post randomization)
  • Functional communication assessed by CETI(four month post randomization)
  • Language function other than naming (comprehension ) assessed by NGA(four month post randomization)
  • Comprehension immediately after intervention assessed by NGA(immediately after intervention (4 weeks))
  • Sentence Production by VAST(immediately after intervention (4 weeks))
  • Naming immediately after intervention assessed by NGA(immediately after intervention (4 weeks))
  • Experiences of patients with the telerehabilitation by semi-structured interviews.(through study completion, an average of 2 year)

研究者

发起方
Sunnaas Rehabilitation Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank Becker

Clinical Medical Director, Associate professor

Sunnaas Rehabilitation Hospital

研究点 (2)

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