NCT06168721

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2025

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

December 4, 2023

Last Update Submit

February 13, 2025

Conditions

Keywords

ICFMusculoskeletal DiseasesPhysical Therapy ModalitiesPrimary Health CareCommunity Health Services

Outcome Measures

Primary Outcomes (2)

  • Relevance of candidate ICF categories (First Delphi Round)

    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)

    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 Outcomes (1)

  • Missing functioning concepts (First Delphi Round)

    2024-01/2024-06

Other Outcomes (1)

  • Sociodemographic data of the sample

    2024-01/2024-06

Study Arms (1)

Expert panel

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

Other: Expert survey

Interventions

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.

Expert panel

Eligibility Criteria

Age26 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Work in a rehabilitation center or hospital context.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ólvega Primary Health Center

Ólvega, Soria, 42110, Spain

Location

Related Publications (5)

  • 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.

    PMID: 35830343BACKGROUND
  • 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.

    PMID: 36830831BACKGROUND
  • 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.

    PMID: 37667886BACKGROUND
  • 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.

    PMID: 37974517BACKGROUND
  • 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.

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 13, 2023

Study Start

January 22, 2024

Primary Completion

September 24, 2024

Study Completion

January 25, 2025

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
From the publication of the study, with no time limit.
Access Criteria
Access to this data will be conditioned by the type of publication.

Locations