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临床试验/NCT06717776
NCT06717776已完成不适用

Effects of Compensation-Based Problem-Solving Therapy on Occupational Performance, Self Efficacy, Participation and Quality of Life After Stroke: A Randomized Controlled Trial

Hacettepe University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年9月1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
52
试验地点
1
主要终点
The Canadian Occupational Performance Measure (COPM)

研究概览

简要总结

The aim of the study was to develop a Compensation-Based Problem-Solving Therapy and to examine its effects on occupational performance, participation, self-efficacy, and quality of life in individuals with stroke.

详细描述

The study was designed as a randomized controlled trial. 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 on May 17, 2023, and was assigned the code AEŞH-EK1-2023-176. 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

  • Individuals with ischemic stroke due to middle cerebral artery lesion 18-64 years of age Stroke time between 3-12 months Scoring 24 and above on the Standardized Mini Mental Test Scoring 16 and below on the NIH Stroke Scale Receiving service in the inpatient service at Etlik City Hospital

排除标准

  • Having any psychiatric or neurological disease that may affect the study Individuals whose affected hand is not their dominant hand Individuals who tend to neglect their affected hand

研究组 & 干预措施

Aspirin (intervention group)

Active Comparator

The intervention group received both compensation-bocused problem-solving therapy and standard rehabilitation services.

Standard Rehabilitation:The program allows individuals to utilize the physiotherapy and occupational therapy units on a weekly basis, with access available on weekdays.

Compensation Based Problem Solving Therapy (CFPS) is an approach based on the occupational adaptation model. It entails the implementation of compensatory strategies with the objective of enhancing the performance of both extremities in activities of daily living.

干预措施: Compensation Based Problem Solving Therapy (Behavioral)

Aspirin (intervention group)

Active Comparator

The intervention group received both compensation-bocused problem-solving therapy and standard rehabilitation services.

Standard Rehabilitation:The program allows individuals to utilize the physiotherapy and occupational therapy units on a weekly basis, with access available on weekdays.

Compensation Based Problem Solving Therapy (CFPS) is an approach based on the occupational adaptation model. It entails the implementation of compensatory strategies with the objective of enhancing the performance of both extremities in activities of daily living.

干预措施: standard rehabilitation (Behavioral)

Plasebo (control group)

Active Comparator

The control group received standard rehabilitation services.

Standard Rehabilitation:The program allows individuals to utilize the physiotherapy and occupational therapy units on a weekly basis, with access available on weekdays.

干预措施: standard rehabilitation (Behavioral)

结局指标

主要结局

The Canadian Occupational Performance Measure (COPM)

时间窗: 1 month

The Canadian Occupational Performance Measure (COPM) is a measurement tool that is specific to the individual and is used to evaluate the performance and satisfaction of individuals in their activities of daily living. The COPM employs a person-centered approach, encompasses a comprehensive scope, and assesses performance and satisfaction. The tool includes the following components: problem definition, prioritization, scoring, goal setting, and re-evaluation. The COPM comprises three domains of occupational performance: self-care, work and productive activities, and leisure time activities. The individual's desired occupations within these areas are identified and assigned a score between 1 and 10. Subsequently, the five most significant occupations are identified from the aforementioned list and performance and satisfaction scores are assigned a value between 1 and 10. The total performance and total satisfaction levels of these occupations are then recorded. Additionally, the total

次要结局

  • The Stroke Specific Quality of Life Scale (SSQLS)(1 month)
  • Daily Living Self Efficacy Scale(1 month)
  • Participation Scale(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 (1)

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