Inter- and Intra-Observer Reliability of the Iowa Level of Assistance Scale and the Effect of Staff Retraining (ILOA)

January 8, 2026 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

To evaluate intra-observer reliability, the scoring procedure will be repeated on two separate occasions at least two weeks apart, using the same video recordings.

Study Type

Observational

Enrollment (Estimated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy
        • Recruiting
        • SAITeR IRCCS Istituto Ortopedico Rizzoli
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will recruit both patients and physiotherapists. Patients will be those who, according to routine clinical practice, are assessed using the Iowa Level of Assistance (ILoA) scale and who provide informed consent to participate in the study and to be video-recorded. Physiotherapists will administer the ILoA scale during clinical assessments and, subsequently, will reassess patient performance by reviewing the video recordings of the participating patients.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter- and Intra-Observer Reliability of the Iowa Level of Assistance (ILoA) Scale
Time Frame: 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.
Baseline (pre-training) and within 6 months after completion of staff training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Mattia Morri, IRCCS Istotuto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 522/2025/Oss/IOR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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