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

NCT07330011 | Recruiting

• 1 other identifier: 522/2025/Oss/IOR
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Replacement; Functional Recovery; Reliability

Keywords

ILOA scale

Outcome Measures

Primary Outcomes (1)

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

  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.

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

SAITeR IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy

RECRUITING

Related Publications (4)

• Yang Y, Wang Y, Zhou Y, Chen C, Xing D. Reliability of functional gait assessment in patients with Parkinson disease: Interrater and intrarater reliability and internal consistency. Medicine (Baltimore). 2016 Aug;95(34):e4545. doi: 10.1097/MD.0000000000004545.

  PMID: 27559954 RESULT

• Shields RK, Enloe LJ, Evans RE, Smith KB, Steckel SD. Reliability, validity, and responsiveness of functional tests in patients with total joint replacement. Phys Ther. 1995 Mar;75(3):169-76; discussion 176-9. doi: 10.1093/ptj/75.3.169.

  PMID: 7870749 RESULT

• Morri M, Franchini N, Gerini G, Morabito R, Pignotti E, Benedetti MG, Marchese O, Zanotti E. Measuring functional performance at discharge from hospital after total joint arthroplasty as a pre-requisite for planning early rehabilitation: a prognostic study. Orthop Nurs. 2015 Mar-Apr;34(2):95-100. doi: 10.1097/NOR.0000000000000126.

  PMID: 25785619 RESULT

• Benedetti MG, Franchignoni F, Morri M, Franchini N, Natali E, Giordano A. Rasch analysis of the Iowa Level of Assistance Scale in patients with total hip and knee arthroplasty. Int J Rehabil Res. 2014 Jun;37(2):118-24. doi: 10.1097/MRR.0000000000000043.

  PMID: 24406302 RESULT

Study Officials

• Mattia Morri

  IRCCS Istotuto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattia Morri

CONTACT

+390516366694; mattia.morri@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 9, 2026
• Study Start: November 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

IT (1)