- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06168721
ICF Core Set for Primary Care Physiotherapy
Development of an ICF Core Set for the Management of Musculoskeletal Conditions in Primary Care Physiotherapy Services
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Soria
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Ólvega, Soria, Spain, 42110
- Ólvega Primary Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Expert panel
This group will be composed of experts in primary care physiotherapy.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Relevance of candidate ICF categories (First Delphi Round)
Time Frame: 2024-01/2024-06
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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).
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2024-01/2024-06
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Judgment on the clinical utility of the selected ICF categories (Second Delphi Round)
Time Frame: 2024-01/2024-06
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Dichotomous question (yes/no) on the appropriateness of including or excluding the most relevant ICF categories in the ICF core set.
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2024-01/2024-06
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Missing functioning concepts (First Delphi Round)
Time Frame: 2024-01/2024-06
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Open-ended question related to ICF
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2024-01/2024-06
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sociodemographic data of the sample
Time Frame: 2024-01/2024-06
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Data set for the characterization of the expert panel (age, gender, education level, work experience and information on the current job)
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2024-01/2024-06
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Collaborators and Investigators
Sponsor
Collaborators
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
General Publications
- 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.
- 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.
- 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.
- 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.
- 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 Feb 11:1-10. doi: 10.1080/09638288.2025.2460723. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIm 2987
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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