跳至主要内容
临床试验/NCT07330011
NCT07330011招募中不适用

Inter- and Intra-observer Reliability of the Iowa Level of Assistance (ILoA) Scale for Measuring Postoperative Functional Recovery in Orthopedic Patients: an Observational Study

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年11月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
1
主要终点
Inter- and Intra-Observer Reliability of the Iowa Level of Assistance (ILoA) Scale

研究概览

简要总结

The aim of this study is to evaluate, in routine clinical practice, the inter- and intra-observer reliability of the Iowa Level of Assistance (ILoA) scale, which is regularly used to assess functional recovery in orthopedic patients. A secondary objective is to investigate the impact of a structured retraining program for healthcare staff on the use of the ILoA scale and to determine whether this intervention influences the reliability indices of the scale.

详细描述

The study will be conducted among healthcare professionals of the Istituto Ortopedico Rizzoli (IOR). The Iowa Level of Assistance (ILoA) scale has been integrated into the institutional Care Pathways for patients undergoing hip and knee arthroplasty and for patients with femoral fractures, and it is routinely used by rehabilitation healthcare staff.

Retrospective Phase

Pre-training scale assessment To evaluate potential changes in the reliability of the ILoA scale, a retrospective control group will be constructed using video-based assessments that were previously collected as part of a monitoring activity. The procedures for video recording and ILoA scale administration used during this retrospective phase were comparable to those planned for the present study, allowing meaningful comparison of reliability indices.

Prospective Phase

Post-training scale assessment At least three months after completion of the retraining program, a new data collection phase will be conducted. All participating physiotherapists will be asked to independently score the ILoA scale for a group of patients who have undergone hip or knee arthroplasty or osteosynthesis, using standardized video recordings. Assessments will be performed anonymously by the observers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • For Observers (Physiotherapists):
  • All physiotherapists working at the main Istituto Ortopedico Rizzoli (IOR) site in Bologna or at the two satellite sites in Argenta and Bagheria.
  • Physiotherapists must have the role of observers in the study. All physiotherapists affiliated with the SAITeR service who have previously received initial training in the use of the ILoA scale; newly hired staff must have completed the specific training pathway.
  • For Patients:
  • Patients admitted to IOR Bologna or Argenta for whom administration of the ILoA scale is part of routine clinical practice.
  • Patients undergoing primary hip or knee arthroplasty for osteoarthritis. Patients undergoing revision hip or knee arthroplasty. Patients undergoing hip arthroplasty or osteosynthesis for femoral fracture.

排除标准

  • Refusal or inability to provide informed consent (for both physiotherapists and patients).

结局指标

主要结局

Inter- and Intra-Observer Reliability of the Iowa Level of Assistance (ILoA) Scale

时间窗: Baseline (pre-training) and within 6 months after completion of staff training.

The Iowa Level of Assistance (ILoA) scale assesses five functional activities: moving to a sitting position, static standing, walking, stair negotiation, and gait speed. For each activity, a score is assigned based on the level of assistance provided, ranging from 0 (independent) to 6 (activity not performed), and on the type of assistive device used, ranging from 0 (no device) to 5 (use of a walker). The total ILoA score ranges from 0 (minimal assistance) to 50 (maximal assistance). The primary outcome of this study is the inter- and intra-observer reliability of the ILoA scale. Inter-observer reliability will be defined as the level of agreement between different observers assessing the same patient under identical clinical conditions, while intra-observer reliability will be defined as the level of agreement between repeated assessments performed by the same observer on the same patient.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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