Adaptation and Validation of the LUNS for Use in Turkey.

July 4, 2025 updated by: Ali Yavuz Karahan, Uşak University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Uşak, Turkey, 64200
        • University of Usak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 9 months
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)
through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uşak University

Collaborators

Istanbul University
Ankara University

Investigators

  • Principal Investigator: AYSUN GENC, Assoc. Prof, Ankara University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
  • Principal Investigator: AYSE A KUCUKDEVECI, Prof, Ankara University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
  • Principal Investigator: AYSE YALIMAN, Prof, Istanbul University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
  • Principal Investigator: ATILLA H ELHAN, Prof, Ankara University, Faculty of Medicine, Department of Biostatistics
  • Principal Investigator: EKIN I SEN, Assoc. Prof, Istanbul University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

July 4, 2025

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 4, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ayk22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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