StrokeNCT05434052
Turkish Adaptation, Validity and Reliability of Community Integration Questionnaire-Revised (CIQ-R)
An observational study of Stroke and Community Integration, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to adapt the Community Integration Questionnaire-Revised (CIQ-R) scale to Turkish society and to make its validity and reliability in Turkish. The CIQ-R scale developed by Callaway et al assesses home integration, social integration, productivity, and electronic social networking in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Community Integration
- What is being tested?
- Turkish Validity and Reliability of The CIQ-R Scale
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2022to 5 Sep 2023
- How long will I take part?
- 15 Days
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients who are aged 18-65 years with duration of hemiplegia ≤ 3 years and able to speak and read Turkish.
Who may be able to join
- Patients with
- duration of hemiplegia ≤ 3 year
- able to speak and read Turkish
- those with a Mini Mental State Examination score of 24 and above
Who cannot join
- communication or cognitive problems,
- aphasia and speech disorders
- unstable medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to adapt the Community Integration Questionnaire-Revised (CIQ-R) scale to Turkish society and to make its validity and reliability in Turkish. The CIQ-R scale developed by Callaway et al assesses home integration, social integration, productivity, and electronic social networking in neurological diseases. It has 18 questions. This study will be conducted with stroke patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 130 participants will be included in the study. In order to evaluate the validity of the CIQ-R, the Mini Mental State Examination (MMSE), which can evaluates general cognitive functioning and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.
Read the detailed description
The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion.
The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. If the developer of the scale, Callaway and Willer approves the translation of the scale, participants will be recruited for the study. In the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of CIQ-R will be able to be modified. The data of CIQ-R are collecting through face-to-face when the patients came to the rehabilitation center. 145 participants will be included in the study.
In order to evaluate the validity of the CIQ-R, the Mini Mental State Examination (MMSE), which can evaluates general cognitive functioning and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.
- Conditions
- Stroke, Community Integration
- Being tested
- Turkish Validity and Reliability of The CIQ-R Scale
- Keywords
- stroke, social networking, social participation, community integration
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Validity and Reliability of The CIQ-R ScaleOther
The aim of this study is to adapt the Community Integration Questionnaire-Revised (CIQ-R)scale to Turkish society and to make its validity and reliability in Turkish. It has 18 questions. This study will be conducted with stroke patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions.
| Study group | Role | What they receive |
|---|---|---|
| stroke patients | The aim of this study is to adapt the Community Integration Questionnaire-Revised (CIQ-R)scale to Turkish society in stroke patients and to make its validity and reliability in Turkish. Receives: Other: Turkish Validity and Reliability of The CIQ-R Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
community integration
community integration will be assessed with the Community Integration Questionnaire-Revised (CIQ-R) scale. It consists of 18 items in total. Each item is scored on a scale of 0-2 includes four sub-categories: Home Integration (HI), Social Integration (SI), Productivity (P), and Electronic Social Network (ESN).
The total score is the calculated sum of 18 items. The minimum score is 0 and the maximum score is 35 points. Higher scores indicate a high level of community integration which means better community integration.
Measured: baseline
Cognitive function
The Mini-Mental State Examination (MMSE), which is a widely used cognitive assessment questionnaire is quite short. It evaluates general cognitive functioning (especially in the left cerebral hemisphere) and ranged from 0 to 30 points. According to the scale results; It is accepted that there is severe cognitive influence between 0-17 points, moderate cognitive influence between 18-23 points, and no cognitive influence between 24-30 points. Higher scores mean better cognitive function.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start3 May 2022
- Primary completion30 Aug 2023
- Study completion5 Sep 2023
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Mete, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434052
- Sponsor's protocol ID
- CIQ-R
- Status last verified
- Oct 2023
- First submitted
- 22 Jun 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Adaptation, Validity and Reliability of Community Integration Questionnaire-Revised (CIQ-R)
- ClinicalTrials.gov ID
- NCT05434052
- Acronym / sponsor ID
- CIQ-R
- Conditions
- Stroke, Community Integration
- Keywords
- stroke, social networking, social participation, community integration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 3 May 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 27 Jun 2022 (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 aim of this study is to adapt the Community Integration Questionnaire-Revised (CIQ-R) scale to Turkish society and to make its validity and reliability in Turkish. The CIQ-R scale developed by Callaway et al assesses home integration, social integration, productivity, and electronic social networking in neurological diseases. It has 18 questions. This study will be conducted with stroke patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions. 130 participants will be included in the study. In order to evaluate the validity of the CIQ-R, the Mini Mental State Examination (MMSE), which can evaluates general cognitive functioning and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.
Detailed description
The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion.
The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. If the developer of the scale, Callaway and Willer approves the translation of the scale, participants will be recruited for the study. In the pre-trial phase, a reassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of CIQ-R will be able to be modified. The data of CIQ-R are collecting through face-to-face when the patients came to the rehabilitation center. 145 participants will be included in the study.
In order to evaluate the validity of the CIQ-R, the Mini Mental State Examination (MMSE), which can evaluates general cognitive functioning and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke patients | – | Other: Turkish Validity and Reliability of The CIQ-R ScaleThe aim of this study is to adapt the Community Integration Questionnaire-Revised (CIQ-R)scale to Turkish society in stroke patients and to make its validity and reliability in Turkish. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients who are aged 18-65 years with duration of hemiplegia ≤ 3 years and able to speak and read Turkish.
Key inclusion criteria (4 listed)
- Patients with
- duration of hemiplegia ≤ 3 year
- able to speak and read Turkish
- those with a Mini Mental State Examination score of 24 and above
Key exclusion criteria (3 listed)
- communication or cognitive problems,
- aphasia and speech disorders
- unstable medical conditions
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 |
|---|---|---|
| Turkish Validity and Reliability of The CIQ-R ScaleThe aim of this study is to adapt the Community Integration Questionnaire-Revised (CIQ-R)scale to Turkish society and to make its validity and reliability in Turkish. It has 18 questions. This study will be conducted with stroke patients. The patients will be sought to answer questionnaires during regular rehabilitation sessions. | Other | stroke patients |
Primary outcome
community integration
Time frame: baseline
community integration will be assessed with the Community Integration Questionnaire-Revised (CIQ-R) scale. It consists of 18 items in total. Each item is scored on a scale of 0-2 includes four sub-categories: Home Integration (HI), Social Integration (SI), Productivity (P), and Electronic Social Network (ESN). The total score is the calculated sum of 18 items. The minimum score is 0 and the maximum score is 35 points. Higher scores indicate a high level of community integration which means better community integration.
Cognitive function
Time frame: baseline
The Mini-Mental State Examination (MMSE), which is a widely used cognitive assessment questionnaire is quite short. It evaluates general cognitive functioning (especially in the left cerebral hemisphere) and ranged from 0 to 30 points. According to the scale results; It is accepted that there is severe cognitive influence between 0-17 points, moderate cognitive influence between 18-23 points, and no cognitive influence between 24-30 points. Higher scores mean better cognitive function.
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 5 Oct 2023.
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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.
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 Stroke and Community Integration, run by Istanbul Medeniyet 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 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: finished, as of the sponsor's last update on 5 Oct 2023. 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?
community integration (time frame: baseline). The study lists 2 primary outcomes in all. 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 5 Oct 2023.