StrokeNCT06278805
Adaptation and Validation of the LUNS for Use in Turkey.
An observational study of Stroke and Disability Physical, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
According to the most up-to-date knowledge, there is no Turkish comprehensive and validated instrument to assess stroke survivors' unmet needs in the longer term. So, this study aims to translate and adapt the LUNS into Turkish and examine its psychometric properties in survivors living at home after a stroke. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Disability Physical, Quality of Life
- What is being tested?
- The reliability and validity study of the T-LUNS
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 4 Jul 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include 110 chronic stroke patients who are in the follow-up of the study centers and attend for an outpatient visit at the Department of Physical Medicine and Rehabilitation
Who may be able to join
- Participants who were diagnosed with stroke
- More than 1 years after the stroke onset
- Age 18 to 70 years
- Had a physical therapy and rehabilitation after stroke
- Cognitive functions are sufficient to fill in the questionnaires in the study
- Who give consent to participate in the study
Who cannot join
- Had delirium, confusion, or other severe consciousness problems
- Suffered from uncontrolled comorbid systemic medical conditions
- Unable to follow commands because of severe cognitive impairment
- Had a serious visual disturbance
- Individuals with musculoskeletal disabilities
- Currently participating in physical therapy or another interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Validation Study of the Longer- Term Unmet Needs After Stroke Questionnaire Into Turkish
According to the most up-to-date knowledge, there is no Turkish comprehensive and validated instrument to assess stroke survivors' unmet needs in the longer term. So, this study aims to translate and adapt the LUNS into Turkish and examine its psychometric properties in survivors living at home after a stroke.
Our hypothesis in this study is:
- The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS) is a valid tool for assessing the unmet needs of stroke patients in the Turkish population.
Read the detailed description
Stroke is one of the top causes of mortality worldwide, and has decreased in many countries, but an increasing number of stroke survivors are living with a disability after being discharged from the hospital. Approximately 25-30% of stroke patients will remain disabled and they will be largely dependent upon their family members and caregivers for their daily living activities. According to patients' perceptions of whether they have received any or enough assistance with a particular challenge, or of whether an issue has not been addressed at all or properly, unmet needs observed by stroke survivors may be practically evaluated. Also, it is critical to identify unmet requirements of stroke survivors in order to inform the delivery of health and social care services. The available data demonstrates that post-acute and chronic stroke survivors have a wide range of unmet requirements. Based on various contextual factors such as the availability of health and social care services, the number of years after stroke, the degree of disability, and demographic parameters, each stroke survivor has, on average, two to five unmet requirements. The Longer-term Unmet Needs after Stroke (LUNS) monitoring tool, is a 22-item questionnaire developed by The Longer-Term Stroke Care (LoTS care) study team (ref1). This questionnaire concerns the need for information as well as the physical, social, and emotional consequences of stroke. According to a cross-sectional study among 850 British stroke survivors, the lower LUNS scores were consistently related to poorer (mental) health according to the Short Form 12 (SF-12) (ref1). Groeneveld et al. translated and cross-culturally adapted the LUNS into Dutch and assessed its psychometric properties in chronic stroke survivors (ref2). Also, LUNS have been translated into different languages such as Korean, Brazil, and Malawi (ref3-4).
According to the most up-to-date knowledge, there is no Turkish comprehensive and validated instrument to assess stroke survivors' unmet needs in the longer term. So, this study aims to translate and adapt the LUNS into Turkish and examine its psychometric properties in survivors living at home after a stroke.
Permission has already been received from Bradford Teaching Hospitals NHS Foundation Trust.
This study will include two stages.; The stage will include the translation and adaptaion procedure of the original English version of the LUNS instrument into Turkish (LUNS-T). The second and the final stage will include the reliability and the validity study of the LUNS-T and this step will be performed according to the guidelines of Beaton et al. for the process of cross-cultural adaptation of self-report measures (ref5). Finally, we will assess the reliability and the validity of LUNS-T.
Stage 1. Translation and adaptation of LUNS into Turkish and establishment of Turkish LUNS (T-LUNS).
This stage will include translation, synthesis, back translation, expert committee review, and pretesting of the pre-final version of T-LUNS according to the guidelines for the process of cross-cultural adaptation of self-report measures proposed by Beaton DE et.al, 2000 (ref5).
Stage 2. Reliability and validity study of the T-LUNS. To test the reliability and validity of the T-LUNS, 110 chronic stroke survivors fulfilling the inclusion/exclusion criteria at the 3 study sites will be assessed. The assessment of each patient will include recording of the demographic and clinical characteristics and administration of the T-LUNS as well as the Turkish version of the Stroke Impact Scale 3.0 (SIS). For the assessment of test-retest reliability of the T-LUNS, half of the participants (n= 55) will fill in the T-LUNS again, 2 weeks after the first administration.
Sample size: It is planned to include at least 110 participants in the study with a 5:1 ratio between the sample size and the number of items (ref6).
Statistical analysis:
Mean, standard deviation, median, interquartile range, frequency, and percentage will be used as descriptive statistics. Student's t-test for continuous variables, Mann Whitney U test for ordinal variables, chi-square test, or Fisher's exact chi-square test for categorical variables will be used for comparisons between two independent groups. Cohen's kappa coefficient will be used to analyze the degree of agreement of the test-retest agreement of the scale items.
An exploratory factor analysis (EFA) for categorical data using the weighted least square method will be used to investigate the dimensionality of the item of the questionnaire (T-LUNS). Model fit will be evaluated using the root-mean-square error of approximation (RMSEA) that accounts for model parsimony. RMSEA values <0.08 suggest adequate fit; values <0.05 indicate good fit (ref7). Items with factor loadings below 0.30 will be eliminated. A p-value less than 0.05 will be considered significant. External construct validity of the T-LUNS will be tested by the investigation of the association with the relevant domains of the Stroke Impact Scale.
- Conditions
- Stroke, Disability Physical, Quality of Life
- Being tested
- The reliability and validity study of the T-LUNS
- Keywords
- Stroke, Unmet need, Disability, Quality of Life, Participation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The reliability and validity study of the T-LUNSOther
To test the reliability and validity of the T-LUNS, 110 chronic stroke survivors fulfilling the inclusion / exclusion criteria at the 3 study sites will be assessed. The assessment of each patient will include recording of the demographic and clinical characteristics and administration of the T-LUNS as well as the Turkish version of the Stroke Impact Scale 3.0 (SIS). For the assessment of test-retest reliability of the T-LUNS, half of the participants (n= 55) will fill in the T-LUNS again, 2 weeks after the first administration.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Participants with chronic stroke who have more than 1 year after stroke onset and who fulfill the inclusion/exclusion criteria will be included in this single-arm study. Receives: Other: The reliability and validity study of the T-LUNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS)
After translation and adaptation of the LUNS into Turkish the T-LUNS will be created. The T-LUNS will be used to identify longer-term unmet needs of stroke patients in the areas of information, services, social and emotional consequences, health problems, and related areas. The T-LUNS includes 22 statements that express a need for in- formation or advice ("I would like advice on employment after stroke"); a need for assistance or aids ("I need additional aids or adaptations inside the home"); or worries or complaints ("I am worried that I might fall [again] and this is stopping me from doing usual things"). Each item has a "yes or no" response, with the "no" option applying to either no need or fulfillment of a need. Based on Rasch and factor analysis in previous research, the original developers of the LUNS considered the scale neither suitable for the calculation of a total score nor for division into domains.
Measured: through study completion, an average of 9 months
The Stroke Impact Scale 3.0 (SIS)
The Stroke Impact Scale (3.0) is a 59-item self-report assessment of stroke outcome used to assess Health-related quality of life (HRQoL). The Stroke Impact Scale has 8 domains: strength, hand function, mobility, physical and instrumental activities of daily living (ie, ADLs and IADLs), memory and thinking, communication, emotion, and social participation. Scores for each domain range from 0 to 100, and higher scores indicate a better HRQoL. Four of the subscales (strength, hand function, ADLs/IADLs, and mobility) can be combined into a composite physical domain. The Stroke Impact Scale also includes a question (item 50) to assess the patient's global perception of recovery. The respondent is asked to rate his or her percentage of recovery on a visual analog scale of 0 to 100, with 0 meaning no recovery and 100 meaning full recovery.Turkish version of the SIS, which was validated before, will be used (ref8)
Measured: through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Jul 2025
- Study completion4 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University, Istanbul University
- Responsible party
- Principal investigator, Ali Yavuz Karahan, Uşak University
- Investigators
- AYSUN GENC, Assoc. Prof, Principal investigator, Ankara University, Faculty of Medicine, Department of Physical Medicine and RehabilitationAYSE A KUCUKDEVECI, Prof, Principal investigator, Ankara University, Faculty of Medicine, Department of Physical Medicine and RehabilitationAYSE YALIMAN, Prof, Principal investigator, Istanbul University, Faculty of Medicine, Department of Physical Medicine and RehabilitationATILLA H ELHAN, Prof, Principal investigator, Ankara University, Faculty of Medicine, Department of BiostatisticsEKIN I SEN, Assoc. Prof, Principal investigator, Istanbul University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278805
- Sponsor's protocol ID
- ayk22
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2023
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
Publications
LoTS care LUNS study team. Validation of the longer-term unmet needs after stroke (LUNS) monitoring tool: a multicentre study. Clin Rehabil. 2013 Nov;27(11):1020-8. doi: 10.1177/0269215513487082. Epub 2013 Jun 20.
PubMed 23787941Groeneveld IF, Arwert HJ, Goossens PH, Vliet Vlieland TPM. The Longer-term Unmet Needs after Stroke Questionnaire: Cross-Cultural Adaptation, Reliability, and Concurrent Validity in a Dutch Population. J Stroke Cerebrovasc Dis. 2018 Jan;27(1):267-275. doi: 10.1016/j.jstrokecerebrovasdis.2017.08.043. Epub 2017 Sep 28.
PubMed 28967592Wellappuli NT, Perera HSR, Kasthuriratne G, Chang T, Gunawardena NS. Adaptation and validation of the Longer-term Unmet Needs after Stroke (LUNS) monitoring tool in Sri Lanka. BMC Public Health. 2023 Sep 4;23(1):1718. doi: 10.1186/s12889-023-16636-1.
PubMed 37667260Baek S, Kim WS, Park YH, Jung YS, Chang WK, Kim G, Paik NJ. Korean Version of the Longer-Term Unmet Needs After Stroke Questionnaire. Ann Rehabil Med. 2023 Oct;47(5):367-376. doi: 10.5535/arm.23044. Epub 2023 Oct 4.
PubMed 37907228Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735Gorusch RL. Factor Analysis. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1983.
Hart DL, Mioduski JE, Stratford PW. Simulated computerized adaptive tests for measuring functional status were efficient with good discriminant validity in patients with hip, knee, or foot/ankle impairments. J Clin Epidemiol. 2005 Jun;58(6):629-38. doi: 10.1016/j.jclinepi.2004.12.004.
PubMed 15878477Hantal, A. O., Dogu, B., Buyukavci, R., & Kuran, B. (2014). Stroke impact scale version 3.0: study of reliability and validity in stroke patients in the turkish population/Inme etki olcegi 3, 0: turk toplumundaki inmeli hastalarda guvenilirlik ve gecerlilik calismasi. Turkish Journal of Physical Medicine and Rehabilitation, 60(2), 106-117.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Validation Study of the Longer- Term Unmet Needs After Stroke Questionnaire Into Turkish
- ClinicalTrials.gov ID
- NCT06278805
- Acronym / sponsor ID
- ayk22
- Conditions
- Stroke, Disability Physical, Quality of Life
- Keywords
- Stroke, Unmet need, Disability, Quality of Life, Participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Collaborators
- Ankara University, Istanbul University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 26 Feb 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.
According to the most up-to-date knowledge, there is no Turkish comprehensive and validated instrument to assess stroke survivors' unmet needs in the longer term. So, this study aims to translate and adapt the LUNS into Turkish and examine its psychometric properties in survivors living at home after a stroke.
Our hypothesis in this study is:
- The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS) is a valid tool for assessing the unmet needs of stroke patients in the Turkish population.
Detailed description
Stroke is one of the top causes of mortality worldwide, and has decreased in many countries, but an increasing number of stroke survivors are living with a disability after being discharged from the hospital. Approximately 25-30% of stroke patients will remain disabled and they will be largely dependent upon their family members and caregivers for their daily living activities. According to patients' perceptions of whether they have received any or enough assistance with a particular challenge, or of whether an issue has not been addressed at all or properly, unmet needs observed by stroke survivors may be practically evaluated. Also, it is critical to identify unmet requirements of stroke survivors in order to inform the delivery of health and social care services. The available data demonstrates that post-acute and chronic stroke survivors have a wide range of unmet requirements. Based on various contextual factors such as the availability of health and social care services, the number of years after stroke, the degree of disability, and demographic parameters, each stroke survivor has, on average, two to five unmet requirements. The Longer-term Unmet Needs after Stroke (LUNS) monitoring tool, is a 22-item questionnaire developed by The Longer-Term Stroke Care (LoTS care) study team (ref1). This questionnaire concerns the need for information as well as the physical, social, and emotional consequences of stroke. According to a cross-sectional study among 850 British stroke survivors, the lower LUNS scores were consistently related to poorer (mental) health according to the Short Form 12 (SF-12) (ref1). Groeneveld et al. translated and cross-culturally adapted the LUNS into Dutch and assessed its psychometric properties in chronic stroke survivors (ref2). Also, LUNS have been translated into different languages such as Korean, Brazil, and Malawi (ref3-4).
According to the most up-to-date knowledge, there is no Turkish comprehensive and validated instrument to assess stroke survivors' unmet needs in the longer term. So, this study aims to translate and adapt the LUNS into Turkish and examine its psychometric properties in survivors living at home after a stroke.
Permission has already been received from Bradford Teaching Hospitals NHS Foundation Trust.
This study will include two stages.; The stage will include the translation and adaptaion procedure of the original English version of the LUNS instrument into Turkish (LUNS-T). The second and the final stage will include the reliability and the validity study of the LUNS-T and this step will be performed according to the guidelines of Beaton et al. for the process of cross-cultural adaptation of self-report measures (ref5). Finally, we will assess the reliability and the validity of LUNS-T.
Stage 1. Translation and adaptation of LUNS into Turkish and establishment of Turkish LUNS (T-LUNS).
This stage will include translation, synthesis, back translation, expert committee review, and pretesting of the pre-final version of T-LUNS according to the guidelines for the process of cross-cultural adaptation of self-report measures proposed by Beaton DE et.al, 2000 (ref5).
Stage 2. Reliability and validity study of the T-LUNS. To test the reliability and validity of the T-LUNS, 110 chronic stroke survivors fulfilling the inclusion/exclusion criteria at the 3 study sites will be assessed. The assessment of each patient will include recording of the demographic and clinical characteristics and administration of the T-LUNS as well as the Turkish version of the Stroke Impact Scale 3.0 (SIS). For the assessment of test-retest reliability of the T-LUNS, half of the participants (n= 55) will fill in the T-LUNS again, 2 weeks after the first administration.
Sample size: It is planned to include at least 110 participants in the study with a 5:1 ratio between the sample size and the number of items (ref6).
Statistical analysis:
Mean, standard deviation, median, interquartile range, frequency, and percentage will be used as descriptive statistics. Student's t-test for continuous variables, Mann Whitney U test for ordinal variables, chi-square test, or Fisher's exact chi-square test for categorical variables will be used for comparisons between two independent groups. Cohen's kappa coefficient will be used to analyze the degree of agreement of the test-retest agreement of the scale items.
An exploratory factor analysis (EFA) for categorical data using the weighted least square method will be used to investigate the dimensionality of the item of the questionnaire (T-LUNS). Model fit will be evaluated using the root-mean-square error of approximation (RMSEA) that accounts for model parsimony. RMSEA values <0.08 suggest adequate fit; values <0.05 indicate good fit (ref7). Items with factor loadings below 0.30 will be eliminated. A p-value less than 0.05 will be considered significant. External construct validity of the T-LUNS will be tested by the investigation of the association with the relevant domains of the Stroke Impact Scale.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: The reliability and validity study of the T-LUNSParticipants with chronic stroke who have more than 1 year after stroke onset and who fulfill the inclusion/exclusion criteria will be included in this single-arm study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include 110 chronic stroke patients who are in the follow-up of the study centers and attend for an outpatient visit at the Department of Physical Medicine and Rehabilitation
Key inclusion criteria (6 listed)
- Participants who were diagnosed with stroke
- More than 1 years after the stroke onset
- Age 18 to 70 years
- Had a physical therapy and rehabilitation after stroke
- Cognitive functions are sufficient to fill in the questionnaires in the study
Key exclusion criteria (6 listed)
- Had delirium, confusion, or other severe consciousness problems
- Suffered from uncontrolled comorbid systemic medical conditions
- Unable to follow commands because of severe cognitive impairment
- Had a serious visual disturbance
- Individuals with musculoskeletal disabilities
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 |
|---|---|---|
| The reliability and validity study of the T-LUNSTo test the reliability and validity of the T-LUNS, 110 chronic stroke survivors fulfilling the inclusion / exclusion criteria at the 3 study sites will be assessed. The assessment of each patient will include recording of the demographic and clinical characteristics and administration of the T-LUNS as well as the Turkish version of the Stroke Impact Scale 3.0 (SIS). For the assessment of test-retest reliability of the T-LUNS, half of the participants (n= 55) will fill in the T-LUNS again, 2 weeks after the first administration. | Other | Stroke patients |
Primary outcome
The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS)
Time frame: through study completion, an average of 9 months
After translation and adaptation of the LUNS into Turkish the T-LUNS will be created. The T-LUNS will be used to identify longer-term unmet needs of stroke patients in the areas of information, services, social and emotional consequences, health problems, and related areas. The T-LUNS includes 22 statements that express a need for in- formation or advice ("I would like advice on employment after stroke"); a need for assistance or aids ("I need additional aids or adaptations inside the home"); or worries or complaints ("I am worried that I might fall [again] and this is stopping me from doing usual things"). Each item has a "yes or no" response, with the "no" option applying to either no need or fulfillment of a need. Based on Rasch and factor analysis in previous research, the original developers of the LUNS considered the scale neither suitable for the calculation of a total score nor for division into domains.
The Stroke Impact Scale 3.0 (SIS)
Time frame: through study completion, an average of 9 months
The Stroke Impact Scale (3.0) is a 59-item self-report assessment of stroke outcome used to assess Health-related quality of life (HRQoL). The Stroke Impact Scale has 8 domains: strength, hand function, mobility, physical and instrumental activities of daily living (ie, ADLs and IADLs), memory and thinking, communication, emotion, and social participation. Scores for each domain range from 0 to 100, and higher scores indicate a better HRQoL. Four of the subscales (strength, hand function, ADLs/IADLs, and mobility) can be combined into a composite physical domain. The Stroke Impact Scale also includes a question (item 50) to assess the patient's global perception of recovery. The respondent is asked to rate his or her percentage of recovery on a visual analog scale of 0 to 100, with 0 meaning no recovery and 100 meaning full recovery.Turkish version of the SIS, which was validated before, will be used (ref8)
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 9 Jul 2025.
- Background: PubMed 23787941LoTS care LUNS study team. Validation of the longer-term unmet needs after stroke (LUNS) monitoring tool: a multicentre study. Clin Rehabil. 2013 Nov;27(11):1020-8. doi: 10.1177/0269215513487082. Epub 2013 Jun 20.
- Background: PubMed 28967592Groeneveld IF, Arwert HJ, Goossens PH, Vliet Vlieland TPM. The Longer-term Unmet Needs after Stroke Questionnaire: Cross-Cultural Adaptation, Reliability, and Concurrent Validity in a Dutch Population. J Stroke Cerebrovasc Dis. 2018 Jan;27(1):267-275. doi: 10.1016/j.jstrokecerebrovasdis.2017.08.043. Epub 2017 Sep 28.
- Background: PubMed 37667260Wellappuli NT, Perera HSR, Kasthuriratne G, Chang T, Gunawardena NS. Adaptation and validation of the Longer-term Unmet Needs after Stroke (LUNS) monitoring tool in Sri Lanka. BMC Public Health. 2023 Sep 4;23(1):1718. doi: 10.1186/s12889-023-16636-1.
- Background: PubMed 37907228Baek S, Kim WS, Park YH, Jung YS, Chang WK, Kim G, Paik NJ. Korean Version of the Longer-Term Unmet Needs After Stroke Questionnaire. Ann Rehabil Med. 2023 Oct;47(5):367-376. doi: 10.5535/arm.23044. Epub 2023 Oct 4.
- Background: PubMed 11124735Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
- BackgroundGorusch RL. Factor Analysis. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1983.
- Background: PubMed 15878477Hart DL, Mioduski JE, Stratford PW. Simulated computerized adaptive tests for measuring functional status were efficient with good discriminant validity in patients with hip, knee, or foot/ankle impairments. J Clin Epidemiol. 2005 Jun;58(6):629-38. doi: 10.1016/j.jclinepi.2004.12.004.
- BackgroundHantal, A. O., Dogu, B., Buyukavci, R., & Kuran, B. (2014). Stroke impact scale version 3.0: study of reliability and validity in stroke patients in the turkish population/Inme etki olcegi 3, 0: turk toplumundaki inmeli hastalarda guvenilirlik ve gecerlilik calismasi. Turkish Journal of Physical Medicine and Rehabilitation, 60(2), 106-117.
- International spread of the Longer-term Unmet Needs after Stroke (LUNS) questionnaireLink provided by the sponsor.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
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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.
AYSUN GENC, Assoc. Prof principal investigator
Ankara University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
AYSE A KUCUKDEVECI, Prof principal investigator
Ankara University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
AYSE YALIMAN, Prof principal investigator
Istanbul University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
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 Disability Physical, run by Uşak 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 6 inclusion and 6 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 9 Jul 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?
The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS) (time frame: through study completion, an average of 9 months). 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?
On the ClinicalTrials.gov record for NCT06278805, which also lists 8 linked publications.
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 9 Jul 2025.