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临床试验/NCT06845566
NCT06845566已完成不适用

Formulation of a Novel Compensation Based Intervention to Improve Activities of Daily Living: A Randomized Controlled Pilot Study

Hacettepe University3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月1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
30
试验地点
3
主要终点
The Canadian Occupational Performance Measure (COPM)

研究概览

简要总结

The primary aim of this study was to pilot CBPST as a novel intervention method. By applying it to a pilot group, the research sought to contribute to the existing literature by offering a compensation-based rehabilitation approach

详细描述

The study was designed as prospective and a randomized controlled pilot study. A simple randomization method was employed to randomly assign individuals to two groups (intervention and control groups). A simple randomization method was employed, whereby the intervention and control group papers were selected from a closed envelope. Following the initial evaluation of each participant, one of the papers bearing the designation "intervention" or "control" was selected at random. This decision determined whether the individual would be included in the intervention or control group. The study was conducted in the occupational therapy department of the physical therapy and rehabilitation clinic of Etlik City Hospital. The study was approved by the Ethics Committee of Etlik City Hospital and was assigned the code AEŞH-EK-2025-025. Following approval from the ethics committee, the Compensation-Based Problem Solving Training (CBPST) was developed. The training program was developed in accordance with the tenets of the Occupational Adaptation Model. All subsequent steps were conducted in accordance with the aforementioned model. The adaptive response, as outlined in the model, encompasses the occupational adaptation that is anticipated to occur at the conclusion of the training program. The therapy was then trialled with a pilot group of five individuals, with the aim of refining the content. Subsequently, the final iteration of the training program was established. All individuals included in the study signed a consent form indicating their willingness to participate. This was completed at the outset of the study. All individuals were provided with a standard rehabilitation program comprising five days a week (40 minutes) of routine therapy. In addition to this, the intervention group received CBPST in the form of five days a week (20 minutes) sessions. The evaluations completed at the beginning of the training were repeated one month later.

研究设计

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

盲法说明

The therapist who conducted the assessment tests was unaware of the participants' group assignments (interventon or control)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • a diagnosis of ischemic stroke due to a middle cerebral lesion,
  • age between 18 and 64 years,
  • a score of 24 or above on the Standardized Mini-Mental State Examination --
  • willingness to participate in the study.

排除标准

  • Stroke onset between 3 and 12 months prior to the study,
  • presence of aphasia (speech impairment)
  • diagnosis of another chronic condition that could affect study outcomes

结局指标

主要结局

The Canadian Occupational Performance Measure (COPM)

时间窗: 1 month

It is a scale that includes a semi-structured interview. Activities that individuals have problems with or want to do in self-care, work and productive activities, and leisure activities are determined and given importance points. Then, the most important activities are ranked, and performance and satisfaction points are requested.These scores are made between 0 and 10. The final score is determined by adding the maximum of five activity, performance, and satisfaction scores. The validity and reliability of the scale have been established in the Turkish context.

次要结局

  • Functional Independence Scale (FIM)(1 month)

研究者

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

Leyla Kaya Ozturk

Principal Investigator

Hacettepe University

研究点 (3)

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