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临床试验/NCT04957225
NCT04957225已完成不适用

MIRAA - A National Study on Intensive Rehabilitation of Aphasia and Apraxia of Speech Following Stroke

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年3月10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
25
试验地点
1
主要终点
Evaluation of training, questionnaire to participating Speech and Language Pathologists

研究概览

简要总结

Positive outcomes have been shown following intensive treatment of speech and/or language impairment post stroke, but how to design intensive treatment programs to achieve optimal recovery and neuroplasticity changes needs to be further researched. The purpose of the MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech) project is to study feasibility of intensive intervention for acquired aphasia and apraxia of speech (AOS) after stroke in the regular Swedish health-care according to the updated national guidelines from the Swedish National Board of Health and Welfare.

详细描述

According to the Swedish National Board of Health and Welfare's guidelines for stroke care, persons with aphasia shall be offered intensive rehabilitation by speech-language pathologists. The aphasia rehabilitation is however sparse and unevenly distributed over the country as reported by the Swedish Aphasia Foundation. People with aphasia are seldom offered long-term treatment and intensive therapy is rarely offered. Intensive treatment is defined as at least 4h/week by the National Board of Health and Welfare, but higher intensity can be beneficial if tolerated by the patient.

Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech, MIRAA, is a modified Intensive Comprehensive Aphasia Program (ICAP) intervention program developed in the applicant's research group. MIRAA consists of a selection of evidence-based and/or well-established methods for speech and language rehabilitation as well as computer training. The training is both individual and group based, including communication between participants to promote transfer to real-life situations. Rehabilitation is based on principles that have been shown to promote neuroplasticity changes, such as high training intensity and multiple repetitions of tasks, for learning and relearning after brain injury. The intervention is goal-driven and individualized for high saliency, with focus on each participant's difficulties with language, speech and communication.

Speech and Language Pathologists (SLPs) all over Sweden working with aphasia and/or AOS following stroke are offered to participate in the study. At the time of recruitment, SLPs are invited to respond to a questionnaire about their current practice. SLPs accepting to participate are offered a 2-day workshop and recurring sessions containing introduction to and training in the MIRAA program as well as information about the logistics of the study.

42 SLPs from 23 clinics over the country participate in the study. The SLPs recruit participants with aphasia/AOS from their waiting and offer them a six-week MIRAA rehabilitation program consisting of a combination of individual treatment and group session and computer-assisted/homework training, with the goal level of 60 hours. The content of the program is individually adapted to clinics and participants. Participation in the study is consecutively offered to all individuals with speech language impairment post stroke that meet the inclusion criteria.

Following administration of the MIRAA-program including pre- and post-testing, participating SLPs will complete a questionnaire on their experiences of delivering the intensive intervention and factors hindering and facilitating implementation. Participants with aphasia/AOS and their next of kin will also provide information about their experiences through questionnaires and semi structured interviews, focus groups interviews and participant observations.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Block randomized sealed envelopes handled by external coordinator.

入排标准

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

入选标准

  • •Aphasia minimum 3 months post stroke
  • •Apraxia of Speech minimum 3 months post stroke
  • •Being able to participate in rehabilitation in Swedish (not in need of translator to partake).

排除标准

  • •Severe loss of sight
  • •Severe loss of hearing
  • •Severe cognitive decline

研究组 & 干预措施

Direct intervention

Experimental

Goal level 60 hours of intensive treatment during 6 weeks. Intensive treatment of aphasia and AOS in ICAP-format (MIRAA).

干预措施: MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech) (Behavioral)

Waiting group

No Intervention

No intervention during 6 weeks, testing directly before and after the waiting period. After the waiting period the participants receives the same intervention as the direct intervention arm.

结局指标

主要结局

Evaluation of training, questionnaire to participating Speech and Language Pathologists

时间窗: Directly after intensive treatment

Minimum score 0, maximum score 12. Higher scores mean better outcome on satisfaction with intensive training and effects on speech, language and functional communication.

Evaluation of training, questionnaire to participants

时间窗: Directly after intensive treatment

Minimum score 3, maximum score 12. Higher scores mean better outcome on satisfaction with intensive training and effects on speech, language and functional communication.

次要结局

  • Boston Naming Test (BNT)(Changes from baseline scores at 6 and 16 (+-2) weeks.)
  • Comprehensive Aphasia Test (CAT), subtest cognitive screening(Changes from baseline scores at 6 and 16 (+-2) weeks.)
  • Protocol for Apraxia of Speech (TAX)(Changes from baseline scores at 6 and 16 (+-2) weeks.)
  • Comprehensive Aphasia Test (CAT)(Changes from baseline in language battery scores at 6 and 16 (+-2) weeks.)
  • Communicative Effectiveness Index (CETI)(Changes from baseline scores at 6 and 16 (+-2) weeks.)
  • General Health Questionnaire 12 questions (GHQ-12)(Changes from baseline scores at 6 and 16 (+-2) weeks.)
  • Rating scale for apraxia of speech (SkaFTA, Swedish version of ASRS)(Time Frame: Changes from baseline scores at 6 and 16 (+-2) weeks.)

研究者

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

Ellika Schalling

Associate professor, Speech Language Pathologist

Karolinska Institutet

研究点 (1)

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