Adaptation and Validation of the LUNS for Use in Turkey.

NCT06278805 | Completed

• 1 other identifier: ayk22
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Disability Physical; Quality of Life

Keywords

Stroke; Unmet need; Disability; Quality of Life; Participation

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  through study completion, an average of 9 months

Study Arms (1)

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

Interventions

The reliability and validity study of the T-LUNS OTHER

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.

Stroke patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uşak University: lead
• Ankara University: collaborator
• Istanbul University: collaborator

Study Sites (1)

University of Usak

Uşak, 64200, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 23787941 BACKGROUND

• Groeneveld 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.

  PMID: 28967592 BACKGROUND

• Wellappuli 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.

  PMID: 37667260 BACKGROUND

• Baek 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.

  PMID: 37907228 BACKGROUND

• Beaton 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.

  PMID: 11124735 BACKGROUND

• Gorusch RL. Factor Analysis. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1983.

  BACKGROUND

• 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.

  PMID: 15878477 BACKGROUND

• Hantal, 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.

  BACKGROUND

Related Links

• International spread of the Longer-term Unmet Needs after Stroke (LUNS) questionnaire

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Clinical)

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: February 26, 2024
• Study Start: March 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 4, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)