跳至主要内容
临床试验/NCT04969432
NCT04969432已完成不适用

Effectiveness of Client-centered Intervention Delivered With Face to Face and Telerehabilitation Method After Total Knee Arthroplasty - A Pilot Randomized Controlled Trial

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年1月7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
48
试验地点
1
主要终点
Canadian Occupational Performance Measure

研究概览

简要总结

The current study was conducted to comparison of the Client-centered (CC) intervention with face-to-face (FF) and TR methods after Total Knee Arthroplasty (TKA). The pilot study was planned to examine the impact of the CC intervention on quality of life, perceived occupational performance and satisfaction. The current study was designed according to the CONSORT statement, which provides a standardized method for randomized controlled trial (RCT) design. Approval for the study was granted by the Local Ethics Committee. Written informed consent was obtained from all participants prior to the study.

详细描述

The current study was conducted to comparison of the Client-centered (CC) intervention with face-to-face (FF) and TR methods after Total Knee Arthroplasty (TKA). The pilot study was planned to examine the impact of the CC intervention on quality of life, perceived occupational performance and satisfaction. The current study was designed according to the CONSORT statement, which provides a standardized method for randomized controlled trial (RCT) design. Approval for the study was granted by the Local Ethics Committee. Written informed consent was obtained from all participants prior to the study.

Participants A total of 56 older adults who were admitted to the occupational therapy department of a public university between January 2021 and May 2021 were screened. Participants who were eligible according to the evaluation and inclusion-exclusion criteria one week after TKA were included in the study. The study inclusion criteria were: (1) age between 65 and 75 years; (2) Mini Mental State Examination score of ≥24; (3) education level of at least completion of elementary school; (4) having undergone unilateral TKA surgery; (5) access to technological equipment; and (6) ability to understand and follow verbal instructions. The exclusion criteria were defined as: (1) revision surgery; (2) having any chronic disease that will affect the rehabilitation process; (3) auditory and visual problems that may affect rehabilitation implementation and communication; (4) postoperative complications (e.g., nerve injury and deep vein thrombosis); and (5) attendance of any rehabilitation program (physiotherapy, speech therapy, psychotherapy, etc.) during the study period.

Measurement The demographic characteristics of the participants were recorded, including age, sex, education level, body mass index (BMI), other people in the house where they lived, and marital status. The Mini Mental State Examination was used to determine the cognitive status included in the inclusion criteria. The Canadian Occupational Performance Measure and the Nottingham Health Profile were applied to all the subjects twice, before and after intervention.

Assessments Mini Mental State Examination Mini Mental State Examination (MMSE), which was used in the inclusion criteria of the study, was used to determine the cognitive state of the participants. From a maximum total of 30 points, a score of 24 is accepted as the threshold value, with scores below this value indicating problems in cognitive functions. Turkish validity and reliability studies of the test have been conducted and the researcher found the MMSE positive and negative predictive values .90 and .95 respectively and kappa score .86.

Canadian Occupational Performance Measure The Canadian Occupational Performance Measure (COPM) is a measure that determines the problems faced by individuals in the field of occupational performance through a semi-structured interview. Occupational performance problems are evaluated with self-reported performance and satisfaction scores. In the first step, ADL problems experienced by individuals in the areas of self-care, productivity and leisure are determined and each occupation is scored according to importance. The subject then selects a maximum of 5 occupations according to their importance scores and gives performance and satisfaction scores in a Likert-type system of 1- 10 for each occupation. The overall performance and satisfaction scores are obtained as the total of the performance and satisfaction scores of each occupation divided by the number of occupations. The Turkish version of COPM was used to evaluate the perceived occupational performance and satisfaction. The Turkish adaptation performed and test re-test reliability of Turkish version of COPM performance was .988 and satisfaction .986, indicating excellent reliability.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 65 and 75 years
  • •Mini Mental State Examination score of ≥24
  • •Education level of at least completion of elementary school
  • •Having undergone unilateral TKA surgery
  • •Access to technological equipment
  • •Ability to understand and follow verbal instructions

排除标准

  • •Revision surgery
  • •Having any chronic disease that will affect the rehabilitation process
  • •Auditory and visual problems that may affect rehabilitation implementation and communication
  • •Postoperative complications (e.g., nerve injury and deep vein thrombosis)
  • •Attendance of any rehabilitation program (physiotherapy, speech therapy, psychotherapy, etc.) during the study period

研究组 & 干预措施

Telerehabilitation

Experimental

干预措施: Client-centered (Other)

Face-to-face

Experimental

干预措施: Client-centered (Other)

结局指标

主要结局

Canadian Occupational Performance Measure

时间窗: 40 minutes

Nottingham Health Profile

时间窗: 10 minutes

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

Berkan Torpil, PhD

Principal Investigator

Saglik Bilimleri Universitesi

研究点 (1)

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