Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326229
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-03-16
Brief Title:
Clinical Validation of Musculoskeletal ICF Core Set in Primary Care Physiotherapy
Sponsor:
University of Valladolid
Organization:
University of Valladolid
Study Overview
Official Title:
Clinical Validation of the Content of an ICF Core Set for the Management of Musculoskeletal Conditions in Primary Care Physiotherapy Services
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this observational study is to validate the content of a tailored ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services
The main question it aims to answer is
- Are the ICF entities included in the ICF Core Set under evaluation useful from a clinical point of view
Participants will evaluate the relevance of each ICF entity included in the ICF core set according to their musculoskeletal condition
The main question it aims to answer is
- Are the ICF entities included in the ICF Core Set under evaluation useful from a clinical point of view
Participants will evaluate the relevance of each ICF entity included in the ICF core set according to their musculoskeletal condition
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 were carried out taking as a reference the physiotherapy services in primary care where most of these conditions are treated A preliminary ICF core set was developed from these studies the entities of which were agreed upon through a subsequent cross-sectional study involving a group of primary care physiotherapy experts In order to confirm the usefulness of this ICF core set a cross-sectional study will be developed to assess the clinical relevance of the ICF entities included in it
A multicenter cross-sectional observational study will be carried out in primary care physiotherapy services to assess the relevance of various aspects of functioning in patients with musculoskeletal problems The participants will be people suffering from musculoskeletal problems referred to these services for treatment by a general practitioner The ICF core set will be used as outcome measure and the relevance of its ICF entities will be assessed by the participants For this purpose a 100 mm visual analog scale will be used where 0 will mean no problem and 100 will mean complete problem Scores will be converted into ICF qualifiers The criterion for confirming each ICF entity will be that it represents a problem in at least 5 of the sample Confirmation of the ICF entities will allow the development of an ICF-based clinical tool for the management of musculoskeletal conditions in primary care physiotherapy services
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 were carried out taking as a reference the physiotherapy services in primary care where most of these conditions are treated A preliminary ICF core set was developed from these studies the entities of which were agreed upon through a subsequent cross-sectional study involving a group of primary care physiotherapy experts In order to confirm the usefulness of this ICF core set a cross-sectional study will be developed to assess the clinical relevance of the ICF entities included in it
A multicenter cross-sectional observational study will be carried out in primary care physiotherapy services to assess the relevance of various aspects of functioning in patients with musculoskeletal problems The participants will be people suffering from musculoskeletal problems referred to these services for treatment by a general practitioner The ICF core set will be used as outcome measure and the relevance of its ICF entities will be assessed by the participants For this purpose a 100 mm visual analog scale will be used where 0 will mean no problem and 100 will mean complete problem Scores will be converted into ICF qualifiers The criterion for confirming each ICF entity will be that it represents a problem in at least 5 of the sample Confirmation of the ICF entities will allow the development of an ICF-based clinical tool for the management of musculoskeletal conditions in primary care physiotherapy services
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None