Chronic DiseaseNCT06718036
Validation and Evaluation of the ICF Rehabilitation Set
An observational study of Chronic Disease, run by University of Rzeszow at 1 site in Poland.
Trial summary
Rehabilitation is considered a key health strategy in the 21st century. The aim of rehabilitation is to optimize the functioning of patients. The International Classification of Functioning, Disability and Health (ICF) is a framework for describing and organizing information on functioning and disability. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Validation and evaluation of the use of the ICF Rehabilitation Set in clinical practice
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 15 Dec 2024to 15 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults participating in the therapeutic rehabilitation process
Who may be able to join
- 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.
Who cannot join
- Previous surgeries, with surgical intervention.
- Fractures.
- Severe systemic diseases that prevent the examination, e.g. acute neoplastic disease, exacerbation of chronic diseases, infections.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validation and Evaluation of the ICF Rehabilitation Set: a Polish Clinical Perspective
Rehabilitation is considered a key health strategy in the 21st century. The aim of rehabilitation is to optimize the functioning of patients. The International Classification of Functioning, Disability and Health (ICF) is a framework for describing and organizing information on functioning and disability. Therefore, the aim of the study is to validate and evaluate the application of the ICF Rehabilitation Set in Polish clinical practice.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- Validation and evaluation of the use of the ICF Rehabilitation Set in clinical practice
- Keywords
- Disability, Rehabilitation, ICF
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation and evaluation of the use of the ICF Rehabilitation Set in clinical practiceOther
Validation and evaluation of the use of the ICF Rehabilitation Set in clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Adults participating in the therapeutic rehabilitation process | Not described Receives: Other: Validation and evaluation of the use of the ICF Rehabilitation Set in clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICF Rehabilitation Set
Measured: Time Frame: 2024-12/2025-06]
Secondary outcomes (1)
Index Barthel
Measured: Time Frame: 2024-12/2025-06]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start15 Dec 2024
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Wiśniowska-Szurlej, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718036
- Sponsor's protocol ID
- ICF Rehabilitation Set
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wisniowska-Szurlej A, Sozanska A, Brozonowicz J, Wilmowska-Pietruszynska A, Sozanski B. Validation and evaluation of the application of the ICF Rehabilitation Set: a Polish clinical perspective. BMC Health Serv Res. 2025 Aug 5;25(1):1027. doi: 10.1186/s12913-025-13048-2.
PubMed 40764554
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Evaluation of the ICF Rehabilitation Set: a Polish Clinical Perspective
- ClinicalTrials.gov ID
- NCT06718036
- Acronym / sponsor ID
- ICF Rehabilitation Set
- Conditions
- Chronic Disease
- Keywords
- Disability, Rehabilitation, ICF
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rehabilitation is considered a key health strategy in the 21st century. The aim of rehabilitation is to optimize the functioning of patients. The International Classification of Functioning, Disability and Health (ICF) is a framework for describing and organizing information on functioning and disability. Therefore, the aim of the study is to validate and evaluate the application of the ICF Rehabilitation Set in Polish clinical practice.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults participating in the therapeutic rehabilitation process | – | Other: Validation and evaluation of the use of the ICF Rehabilitation Set in clinical practice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults participating in the therapeutic rehabilitation process
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Previous surgeries, with surgical intervention.
- Fractures.
- Severe systemic diseases that prevent the examination, e.g. acute neoplastic disease, exacerbation of chronic diseases, infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation and evaluation of the use of the ICF Rehabilitation Set in clinical practiceValidation and evaluation of the use of the ICF Rehabilitation Set in clinical practice | Other | Adults participating in the therapeutic rehabilitation process |
Primary outcome
ICF Rehabilitation Set
Time frame: Time Frame: 2024-12/2025-06]
1 secondary outcome
Index Barthel
Time frame: Time Frame: 2024-12/2025-06]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 40764554Wisniowska-Szurlej A, Sozanska A, Brozonowicz J, Wilmowska-Pietruszynska A, Sozanski B. Validation and evaluation of the application of the ICF Rehabilitation Set: a Polish clinical perspective. BMC Health Serv Res. 2025 Aug 5;25(1):1027. doi: 10.1186/s12913-025-13048-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by University of Rzeszow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICF Rehabilitation Set (time frame: Time Frame: 2024-12/2025-06]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06718036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.