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

Observational Joint Replacement Functional Recovery Reliability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: staff training.
Who it may be relevant to
Registry conditions: Joint Replacement, Functional Recovery, Reliability. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

  • Other staff training
    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 outcome measures

  • 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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • SAITeR IRCCS Istituto Ortopedico Rizzoli — Bologna

Publications

  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07330011 · 522/2025/Oss/IOR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗