ICF Core Set for Primary Care Physiotherapy

February 13, 2025 updated by: Héctor Hernández Lázaro, University of Valladolid

Development of an ICF Core Set for the Management of Musculoskeletal Conditions in Primary Care Physiotherapy Services

Primary care physiotherapy services provide community-based care for musculoskeletal conditions. These conditions are often associated with disability and impact on patients' quality of life. The International Classification of Functioning, Disability and Health (ICF) is the global framework for describing disability. ICF Core Sets are ICF-based tools that facilitate the clinical use of this classification. The development of these tools follows a scientific process that combines the perspectives of researchers, patients, professionals, and the care setting. Our research team has conducted preliminary studies and identified candidate ICF categories with good potential for inclusion in a preliminary version of an ICF Core Set for the treatment of musculoskeletal conditions in community physical therapy settings. The aim of this study is to confirm the relevance of the candidate categories and to develop a final version of this ICF Core Set.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Primary care physiotherapy services provide community-based care for musculoskeletal conditions. These conditions are often associated with disability and impact on patients' quality of life. The International Classification of Functioning, Disability and Health (ICF) is the global framework for describing disability. ICF Core Sets are ICF-based tools that facilitate the clinical use of this classification. Some ICF Core Sets are designed to describe the functioning of patients with musculoskeletal problems.

These Core Sets are focused on the acute phase, typical of emergency care, and the post-acute phase, intended for multidisciplinary teams in rehabilitation centers. However, no ICF core set exists for the final stages of these conditions, when the patient has been reintegrated into the community. The development of ICF Core Sets follows a scientific process that integrates the perspectives of researchers, patients, professionals, and the care setting. Therefore, preparatory studies have been carried out, taking as a reference the physiotherapy services in primary care, where most of these conditions are treated.

These preparatory studies have made it possible to draw up a list of ICF categories that are candidates for being part of an ICF core set specific to these services. To confirm the relevance of these categories, a cross-sectional observational study will be developed by recruiting a group of experts. The experts will carry out two rounds of the survey according to the Delphi method. To be part of this group, sufficient expertise in the field of primary care physiotherapy will be required. The categories that reach consensus among these experts will be proposed in the development of a tailored ICF Core Set for primary care physiotherapy services.

The aim of this study is to confirm the relevance of the candidate categories and to develop a final version of an ICF Core Set for the management of musculoskeletal conditions in a primary care physiotherapy clinical setting. The availability of this tool would allow guiding physical therapy assessments, selecting optimal outcome measures, implementing person-centered care, and systematically recording clinical data.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Soria
      • Ólvega, Soria, Spain, 42110
        • Ólvega Primary Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The potential participants in this study should be physical therapists working in a primary care clinical setting. The resulting panel of experts would have sufficient expertise in this area. The study will focus on the Spanish region of 'Castilla and Leon', but efforts will be made to extend the scope to a national level.

Description

Inclusion Criteria:

  • Be physiotherapists working in a primary care setting for the duration of the study.
  • Have more than 5 years of experience in this clinical setting.
  • Evidence of completion of at least 200 hours of additional training, teaching, research, and/or administrative activities related to the clinical setting.

Exclusion Criteria:

  • Work in a rehabilitation center or hospital context.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Expert panel
This group will be composed of experts in primary care physiotherapy.
The expert group will participate in a two-round survey using the Delphi method. The first round aims to assess the relevance of the proposed ICF categories and to identify missing concepts. The second round will aim to confirm the appropriateness of including the selected categories in the ICF core set. Each round will last 3 weeks and the experts will be provided with feedback on the results obtained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relevance of candidate ICF categories (First Delphi Round)
Time Frame: 2024-01/2024-06
The relevance of the categories will be measured on a 5-point Likert scale: "not relevant" (score 1), "hardly relevant" (score 2), "somewhat relevant" (score 3), "relevant" (score 4) and "very relevant" (score 5).
2024-01/2024-06
Judgment on the clinical utility of the selected ICF categories (Second Delphi Round)
Time Frame: 2024-01/2024-06
Dichotomous question (yes/no) on the appropriateness of including or excluding the most relevant ICF categories in the ICF core set.
2024-01/2024-06

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Missing functioning concepts (First Delphi Round)
Time Frame: 2024-01/2024-06
Open-ended question related to ICF
2024-01/2024-06

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic data of the sample
Time Frame: 2024-01/2024-06
Data set for the characterization of the expert panel (age, gender, education level, work experience and information on the current job)
2024-01/2024-06

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Sandra Jiménez del Barrio, PhD, University of Valladolid
  • Study Chair: Luis Ceballos Laita, PhD, University of Valladolid
  • Study Chair: María Teresa Mingo Gómez, PhD, University of Valladolid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Actual)

September 24, 2024

Study Completion (Actual)

January 25, 2025

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The authors confirm that the data supporting the findings of this study will be available within the article and/or its supplementary materials.

IPD Sharing Time Frame

From the publication of the study, with no time limit.

IPD Sharing Access Criteria

Access to this data will be conditioned by the type of publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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