ICF Core Set for Primary Care Physiotherapy

NCT ID: NCT06168721

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-22

Study Completion Date

2025-01-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Musculoskeletal Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Expert panel

This group will be composed of experts in primary care physiotherapy.

Expert survey

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Expert survey

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

26 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanidad de Castilla y León

OTHER

Sponsor Role collaborator

University of Valladolid

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Héctor Hernández Lázaro

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sandra Jiménez del Barrio, PhD

Role: STUDY_CHAIR

University of Valladolid

Luis Ceballos Laita, PhD

Role: STUDY_CHAIR

University of Valladolid

María Teresa Mingo Gómez, PhD

Role: STUDY_CHAIR

University of Valladolid

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ólvega Primary Health Center

Ólvega, Soria, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Hernandez-Lazaro H, Mingo-Gomez MT, Ceballos-Laita L, Medrano-de-la-Fuente R, Jimenez-Del Barrio S. Validation of the international classification of functioning, disability, and health (ICF) core sets for musculoskeletal conditions in a primary health care setting from physiotherapists' perspective using the Delphi method. Disabil Rehabil. 2023 Jul;45(15):2458-2468. doi: 10.1080/09638288.2022.2096128. Epub 2022 Jul 13.

Reference Type BACKGROUND
PMID: 35830343 (View on PubMed)

Hernandez-Lazaro H, Mingo-Gomez MT, Jimenez-Del-Barrio S, Lahuerta-Martin S, Hernando-Garijo I, Medrano-de-la-Fuente R, Ceballos-Laita L. Researcher's Perspective on Musculoskeletal Conditions in Primary Care Physiotherapy Units through the International Classification of Functioning, Disability, and Health (ICF): A Scoping Review. Biomedicines. 2023 Jan 20;11(2):290. doi: 10.3390/biomedicines11020290.

Reference Type BACKGROUND
PMID: 36830831 (View on PubMed)

Hernandez-Lazaro H, Mingo-Gomez MT, Jimenez-Del-Barrio S, Rodriguez-Fernandez AI, Areso-Boveda PB, Ceballos-Laita L. Validation of the International Classification of Functioning, Disability, and Health (ICF) core set for post-acute musculoskeletal conditions in a primary care physiotherapy setting from the perspective of patients using focus groups. Disabil Rehabil. 2024 Aug;46(16):3594-3601. doi: 10.1080/09638288.2023.2251392. Epub 2023 Sep 5.

Reference Type BACKGROUND
PMID: 37667886 (View on PubMed)

Hernandez-Lazaro H, Jimenez-Del Barrio S, Ceballos-Laita L, Lahuerta-Martin S, Medrano-de-la-Fuente R, Hernando-Garijo I, Mingo-Gomez MT. Multicentre cross-sectional study assessing content validity of the International Classification of Functioning, disability and health core set for post-acute musculoskeletal conditions in primary care physiotherapy services. J Rehabil Med. 2023 Nov 16;55:jrm11950. doi: 10.2340/jrm.v55.11950.

Reference Type BACKGROUND
PMID: 37974517 (View on PubMed)

Hernandez-Lazaro H, Mingo-Gomez MT, Jimenez-Del-Barrio S, Simarro-Martin A, Wisniowska-Szurlej A, Ceballos-Laita L. Development of an ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services in Spain: a Delphi study. Disabil Rehabil. 2025 Sep;47(18):4759-4768. doi: 10.1080/09638288.2025.2460723. Epub 2025 Feb 11.

Reference Type RESULT
PMID: 39931756 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEIm 2987

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.