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NCT Number: NCT07330011

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SAITeR IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy

Location status: Recruiting

Location contact

Mattia Morri

CONTACT

[email protected]

+390516366694

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

staff training

Other

A structured training session will be provided to all participating physiotherapists to review the content of the ILoA scale and standardize administration procedures. The training will be delivered by IOR-employed physiotherapists with documented experience in orthopedic patient assessment and in the use of the ILoA scale. For each scale item, potential sources of uncertainty and specific clinical scenarios will be discussed.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mattia Morri

CONTACT

[email protected]

+390516366694

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: ILOA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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