- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06718036
Validation and Evaluation of the ICF Rehabilitation Set
Validation and Evaluation of the ICF Rehabilitation Set: a Polish Clinical Perspective
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
According to the World Health Organization (WHO) rehabilitation is defined as "a set of interventions designed to optimize functioning and reduce disability in individuals with health conditions in interaction with their environment." Rehabilitation is considered a key health strategy in the 21st century. Demographic and epidemiological trends indicate that human functioning is one of the most important indicators of population health, apart from morbidity and mortality. Thus, it suggests that the main focus of healthcare will be on the real health needs generated by long-term treatment of chronic diseases, including comprehensive enhancement and intensification of rehabilitation.
The aim of rehabilitation is to optimize functioning of patients. WHO indicates International Classifications and Terminologies including the International Statistical Classification of Diseases and Related Health Problems (ICD) and the International Classification of Functioning, Disability and Health (ICF) as the global standards for collecting data regarding health, clinical documentation and statistical data aggregation3. ICF and ICD provide health information in relation to diagnosis (ICD) as well as functioning and disability (ICF). The ICF is based on a holistic biopsychosocial disability model that allows for a comprehensive and wide approach to the problems of an individual related to functioning in his/her living environment.
A Polish version of the ICF Rehabilitation Set has been developed, which contains 29 categories and is proposed as framework for harmonizing information on the functioning and disability of people participating in the rehabilitation process. Therefore, the aim of the study is to validate and assess the use of the ICF Rehabilitation Set in Polish clinical practice.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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Rzeszów, Poland
- University of Rzeszow
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Presence of chronic diseases, including: neurological, cardiological, pulmonary and musculoskeletal problems.
- Cognitive state, enabling to answer questions reliably and accurately, minimum 6 points on the AMTS scale
- Adults participating in the rehabilitation process
- Consent to participate in the study.
Exclusion Criteria:
- Previous surgeries, with surgical intervention.
- Fractures.
- Severe systemic diseases that prevent the examination, e.g. acute neoplastic disease, exacerbation of chronic diseases, infections.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adults participating in the therapeutic rehabilitation process
|
Validation and evaluation of the use of the ICF Rehabilitation Set in clinical practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ICF Rehabilitation Set
Time Frame: Time Frame: 2024-12/2025-06]
|
Time Frame: 2024-12/2025-06]
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Index Barthel
Time Frame: Time Frame: 2024-12/2025-06]
|
Time Frame: 2024-12/2025-06]
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- ICF Rehabilitation Set
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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