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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07330011
Acronym
ILOA
Enrollment
42
Registered
2026-01-09
Start date
2025-11-15
Completion date
2026-09-30
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Recovery, Joint Replacement, Reliability

Keywords

ILOA scale

Brief summary

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.

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.

Interventions

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.

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Inter- and Intra-Observer Reliability of the Iowa Level of Assistance (ILoA) ScaleBaseline (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.

Countries

Italy

Contacts

Primary ContactMattia Morri
mattia.morri@ior.it+390516366694

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026