Joint ReplacementILOANCT07330011
Inter- and Intra-Observer Reliability of the Iowa Level of Assistance Scale and the Effect of Staff Retraining
An observational study of Joint Replacement and Functional Recovery, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Replacement, Functional Recovery, Reliability
- What is being tested?
- staff training
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2025to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Refusal or inability to provide informed consent (for both physiotherapists and patients).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
SAITeR IRCCS Istituto Ortopedico Rizzoli
Bologna
Mattia Morri, +390516366694, mattia.morri@ior.it
About this study
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
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.
Read the 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.
- Conditions
- Joint Replacement, Functional Recovery, Reliability
- Being tested
- staff training
- Keywords
- ILOA scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
staff trainingOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-training) and within 6 months after completion of staff training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start15 Nov 2025
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Joint ReplacementStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mattia Morri, Principal investigator, IRCCS Istotuto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330011
- Sponsor's protocol ID
- 522/2025/Oss/IOR
- Acronym
- ILOA
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27559954Shields 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.
PubMed 7870749Morri 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.
PubMed 25785619Benedetti 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.
PubMed 24406302
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07330011
- Acronym / sponsor ID
- ILOA / 522/2025/Oss/IOR
- Conditions
- Joint Replacement, Functional Recovery, Reliability
- Keywords
- ILOA scale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- Refusal or inability to provide informed consent (for both physiotherapists and patients).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| staff trainingA 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. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Results publication: PubMed 27559954Yang 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.
- Results publication: PubMed 7870749Shields 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.
- Results publication: PubMed 25785619Morri 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.
- Results publication: PubMed 24406302Benedetti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mattia Morri principal investigator
IRCCS Istotuto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Replacement and Functional Recovery, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mattia Morri (+390516366694, mattia.morri@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07330011, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.