StrokeICFNCT06753877
Clinical Monitoring Using ICF
A study testing holistic rehabilitation in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The present study examined stroke patients who applied to occupational therapy units within the framework of ICF, following the rehabilitation process, and defining frequently used measurements in terms of ICF codes Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Stroke
- What is being tested?
- holistic rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of stroke, age between 18 and 64 years,
- Being served by hospital, being enrolled in the occupational therapy,
- Volunteering to participate in the study
Who cannot join
- Individuals with orthopedic, psychological or neurological conditions other than stroke that could affect their functioning and those with moderate or severe aphasia were not included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mardin Traning and Rsearch Hospital
Mardin, Artuklu, 47060
About this study
Official title: Clinical Monitoring of Individuals With Stroke During Inpatient Rehabilitation Using ICF:A Short-Term Follow-Up Study
The present study examined stroke patients who applied to occupational therapy units within the framework of ICF, following the rehabilitation process, and defining frequently used measurements in terms of ICF codes
Read the detailed description
The International Classification of Functioning (ICF) is a standardized method frequently used by health professionals. This follow-up study was performed in accordance with the Declaration of Helsinki. The present study examined stroke patients who applied to occupational therapy units within the framework of ICF, following the rehabilitation process, and defining frequently used measurements in terms of ICF codes. Participants were recruited from the patients who applied to the Occupational Therapy Clinic of Etlik City Hospital. Participants who agreed to participate in the study signed an informed consent form. First, the scales were defined within the framework of ICF. Individuals who had a stroke and were hospitalized in the Physiotherapy and Rehabilitation Clinic of Etlik City Hospital and included in the study were evaluated using ICF parameters within the first 3 days of their hospitalization. All individuals were given a holistic rehabilitation program. Individuals who received inpatient treatment and stayed in the hospital for one month were re-evaluated. Other individuals who were not included in the study benefited from traditional inpatient treatment services. Upon evaluating the rehabilitation service within the framework of ICF, significant changes were observed in body functions, activity, and participation. It is recommended that ICF be used by occupational therapists and other health professionals, that the scales be associated with ICF codes, and that holistic rehabilitation services be developed.
- Conditions
- Stroke
- Being tested
- holistic rehabilitation
- Keywords
- stroke, activities of daily living, participation, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
holistic rehabilitationBehavioural
Holistic rehabilitation service All participants in the study were cared for in the inpatient unit. The same physician and nurses followed the participants for 1 month. The participants were regularly taking their medication and had no co-morbidities. All participants stayed in double rooms and all stayed with their caregivers. The assessments were carried out within the first 3 days of admission to the inpatient unit. The second assessments were repeated by the same professional. Rehabilitation interventions were provided by different therapists. Participants were given standard physiotherapy services (electrotherapy, exercise, gait training, hydrotherapy, respiratory therapy) and standard occupational therapy services. Occupational therapy interventions were provided by the researchers. Physiotherapy services were provided by physiotherapists working full-time in the hospital. Physiotherapy was provided 5 days a week and occupational therapy was provided 3 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin (single group) | Experimental | The present study has one group. Holistic rehabilitation service was provided to all individuals. The program involved different therapies. Participants were given standard physiotherapy services (electrotherapy, exercise, gait training, hydrotherapy, respiratory therapy) and standard occupational therapy services. Occupational therapy interventions were provided by the researchers. Receives: Behavioral: holistic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Scale (FIM)
The FIM is a scale that measures a person's level of independence in basic motor and cognitive activities of daily living. It consists of 18 items and assesses 2 sub-areas. 1) motor function and 2) cognitive function. Each item is scored on a detailed scale ranging from 1 to 7 (level 1 = fully dependent, level 7 = fully independent). The total score ranges from 18 to 126. The higher the person's score, the higher the level of independence (Ravaud et al., 1999). The Turkish cultural adaptation study was conducted.
Measured: 1 month
Secondary outcomes (1)
Mini Mental State Examination (MMSE)
The MMSE, which assesses cognitive impairment, is a scale developed. It is a useful, short and standardised tool that can be used to determine cognitive level. It consists of five main sections: orientation, registration, attention and calculation, recall, and language with a total of eleven items. The score range is 0-30. A higher score indicates a higher cognitive level. The Turkish validity and reliability were carried out.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Jun 2024
- Primary completion1 Oct 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group was investigated within the ICF framework
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Kaya Ozturk, Hacettepe University
- Investigators
- leyla kaya öztürk, MSc, Principal investigator, Mardin Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753877
- Sponsor's protocol ID
- HÜ-OT-LKO-02
- Acronym
- ICF
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Monitoring of Individuals With Stroke During Inpatient Rehabilitation Using ICF:A Short-Term Follow-Up Study
- ClinicalTrials.gov ID
- NCT06753877
- Acronym / sponsor ID
- ICF / HÜ-OT-LKO-02
- Conditions
- Stroke
- Keywords
- stroke, activities of daily living, participation, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 31 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.
The present study examined stroke patients who applied to occupational therapy units within the framework of ICF, following the rehabilitation process, and defining frequently used measurements in terms of ICF codes
Detailed description
The International Classification of Functioning (ICF) is a standardized method frequently used by health professionals. This follow-up study was performed in accordance with the Declaration of Helsinki. The present study examined stroke patients who applied to occupational therapy units within the framework of ICF, following the rehabilitation process, and defining frequently used measurements in terms of ICF codes. Participants were recruited from the patients who applied to the Occupational Therapy Clinic of Etlik City Hospital. Participants who agreed to participate in the study signed an informed consent form. First, the scales were defined within the framework of ICF. Individuals who had a stroke and were hospitalized in the Physiotherapy and Rehabilitation Clinic of Etlik City Hospital and included in the study were evaluated using ICF parameters within the first 3 days of their hospitalization. All individuals were given a holistic rehabilitation program. Individuals who received inpatient treatment and stayed in the hospital for one month were re-evaluated. Other individuals who were not included in the study benefited from traditional inpatient treatment services. Upon evaluating the rehabilitation service within the framework of ICF, significant changes were observed in body functions, activity, and participation. It is recommended that ICF be used by occupational therapists and other health professionals, that the scales be associated with ICF codes, and that holistic rehabilitation services be developed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group was investigated within the ICF framework
| Arm | Type | Receives |
|---|---|---|
| Aspirin (single group) | Experimental | Behavioral: holistic rehabilitationThe present study has one group. Holistic rehabilitation service was provided to all individuals. The program involved different therapies. Participants were given standard physiotherapy services (electrotherapy, exercise, gait training, hydrotherapy, respiratory therapy) and standard occupational therapy services. Occupational therapy interventions were provided by the researchers. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of stroke, age between 18 and 64 years,
- Being served by hospital, being enrolled in the occupational therapy,
- Volunteering to participate in the study
Key exclusion criteria (1 listed)
- Individuals with orthopedic, psychological or neurological conditions other than stroke that could affect their functioning and those with moderate or severe aphasia were not included in the study
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 |
|---|---|---|
| holistic rehabilitationHolistic rehabilitation service All participants in the study were cared for in the inpatient unit. The same physician and nurses followed the participants for 1 month. The participants were regularly taking their medication and had no co-morbidities. All participants stayed in double rooms and all stayed with their caregivers. The assessments were carried out within the first 3 days of admission to the inpatient unit. The second assessments were repeated by the same professional. Rehabilitation interventions were provided by different therapists. Participants were given standard physiotherapy services (electrotherapy, exercise, gait training, hydrotherapy, respiratory therapy) and standard occupational therapy services. Occupational therapy interventions were provided by the researchers. Physiotherapy services were provided by physiotherapists working full-time in the hospital. Physiotherapy was provided 5 days a week and occupational therapy was provided 3 days a week. | Behavioural | Aspirin (single group) |
Primary outcome
Functional Independence Scale (FIM)
Time frame: 1 month
The FIM is a scale that measures a person's level of independence in basic motor and cognitive activities of daily living. It consists of 18 items and assesses 2 sub-areas. 1) motor function and 2) cognitive function. Each item is scored on a detailed scale ranging from 1 to 7 (level 1 = fully dependent, level 7 = fully independent). The total score ranges from 18 to 126. The higher the person's score, the higher the level of independence (Ravaud et al., 1999). The Turkish cultural adaptation study was conducted.
1 secondary outcome
Mini Mental State Examination (MMSE)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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. This study is not recruiting at the moment.
leyla kaya öztürk, MSc principal investigator
Mardin Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing holistic rehabilitation in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 29 Dec 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Independence Scale (FIM) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025.