NCT07117591|Completed
Restless Legs Syndrome and Sleep Quality in Pes Planus
FLAT-RLS
Frequency of Restless Legs Syndrome and Its Impact on Sleep Quality in Patients With Pes Planus: A Multicenter Observational Study
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FLAT-RLS
Frequency of Restless Legs Syndrome and Its Impact on Sleep Quality in Patients With Pes Planus: A Multicenter Observational Study
Sponsor study identifier
observational
242
1 country
1
Study Start
December 1, 2024
Actual (reported)Primary Completion
July 1, 2025
Actual (reported)Study Completion
July 1, 2025
Actual (reported)Pes planus, also known as flatfoot, is a common foot deformity that can affect the biomechanics of the lower limbs. However, its relationship with neurological conditions has not been studied extensively. Restless Legs Syndrome is a neurological disorder characterized by uncomfortable sensations in the legs and an urge to move them, especially during periods of rest, which can negatively affect sleep quality. The aim of this multicenter cross-sectional study, conducted at Etlik Zübeyde Hanım Women's Health Training and Research Hospital, Etlik City Hospital in Ankara, and Yozgat City Hospital, is to determine the frequency of Restless Legs Syndrome in patients diagnosed with pes planus and to examine its effects on pain, emotional status, sleep quality, and quality of life. The study included 122 patients aged between 18 and 65 years with clinically diagnosed pes planus, and 120 healthy individuals matched for age and sex. Participants were assessed using the International Restless Legs Syndrome Study Group Diagnostic Criteria and Severity Rating Scale for Restless Legs Syndrome, the Visual Analog Scale and Foot Function Index for pain and foot function, the Hospital Anxiety and Depression Scale for emotional status, the Pittsburgh Sleep Quality Index for sleep quality, and the Short Form-36 Health Survey for quality of life.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2024
Actual (reported)July 1, 2025
Actual (reported)July 1, 2025
Actual (reported)August 5, 2025
Actual (reported)August 12, 2025
Actual (reported)The International Restless Legs Syndrome Study Group Diagnostic Criteria
Restless Legs Syndrome will be diagnosed using the International Restless Legs Syndrome Study Group Diagnostic Criteria, which consist of five essential clinical criteria. All criteria must be met for diagnosis. These include: (1) an urge to move the legs; (2) symptoms that begin or worsen during rest or inactivity; (3) symptoms relieved by movement; (4) symptoms worse in the evening or at night; and (5) symptoms not solely accounted for by another medical or behavioral condition.This tool, originally developed in 1995 and revised in 2014, includes five essential diagnostic criteria and is based solely on clinical history. All criteria must be met for a diagnosis of restless legs syndrome
At baseline
The International Restless Legs Syndrome Study Group Criteria Severity Rating Scale
The severity of Restless Legs Syndrome symptoms will be assessed using the International Restless Legs Syndrome Study Group Severity Rating Scale. This is a validated 10-item questionnaire that evaluates symptom intensity, frequency, sleep disruption, and the psychosocial impact of Restless Legs Syndrome. Each item is scored from 0 to 4, with total scores ranging from 0 to 40. Severity is categorized as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40). The scale has been validated for use in Turkish populations.Total severity score (range 0-40) and severity category distribution (mild/moderate/severe/very severe).
Participants in this group were clinically diagnosed with pes planus (flatfoot) by a physical medicine and rehabilitation specialist, based on physical examination findings. Individuals were aged between 18 and 65 years and presented with lower extremity pain. No intervention was applied. This group was evaluated using standardized questionnaires to assess the presence and severity of Restless Legs Syndrome, pain levels, emotional status, sleep quality, and quality of life.
This group included healthy volunteers between the ages of 18 and 65 who had no clinical signs of pes planus or lower extremity pain. Participants were matched to the patient group by age and sex. No medical or rehabilitative intervention was applied. They were evaluated using the same standardized tools to assess the presence of Restless Legs Syndrome, emotional status, sleep quality, and quality of life, for comparison with the patient group.
This study includes adult patients aged 18-65 with clinically diagnosed pes planus and age- and sex-matched healthy controls without foot deformity or leg pain. Participants were recruited from three tertiary hospitals in Turkey and evaluated for Restless Legs Syndrome, pain, emotional status, sleep quality, and quality of life.
Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Yozgat, Yozgat, 66100, Turkey (Türkiye)
Kocyigit H (1999) Turkish validity and reliability of short-form 36. Drug Treat 12:102-106
Ağargün MY (1996) Validity and reliability of Turkish version of Pittsburgh Sleep Quality Index. Türk Psikiyatri Dergisi 7:107
Aydemir O, Güvenir T, Küey L, Kültür S (1997) Reliability and validity of the Turkish version of hospital anxiety and depression scale. Turkish journal of psychiatry 8:280-287
Ay E (2017) Huzursuz bacaklar sendromunda kullanılan uluslararası huzursuz bacaklar sendromu çalışma grubu şiddet ölçeğinin türkçe geçerlilik ve güvenilirliğinin araştırılması. In. Sağlık Bilimleri Enstitüsü.
Gülseren Demir Karakılıç, Asst Prof
Yozgat Bozok University
242 participants (actual enrollment reported by the registry).
First Submitted
August 5, 2025
First Posted
August 12, 2025
Study Start
December 1, 2024
Actual (reported)Contribution of Ultrasonography in Patellofemoral Pain Syndrome
At baseline
The Pittsburg Sleep Quality Index
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, a 24-item self-reported questionnaire that evaluates sleep quality and disturbances over the past month. Scores range from 0 to 21, with higher scores indicating poorer sleep quality. A total score of 5 or above is used to define poor sleep quality. The index has been validated in Turkish populations.Total Pittsburgh Sleep Quality Index score and proportion of participants classified as poor sleepers (score ≥5)
At baseline
The Foot Function Index
At baseline
The Hospital Anxiety and Depression Scale
At baseline
SF-36
At baseline
Contact the study team to confirm eligibility.
Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
YALIMAN A, ŞEN Eİ, ESKİYURT N, BUDIMAN-MAK E (2014) Ayak Fonksiyon İndeksi'nin Plantar Fasiitli Hastalarda Türkçe'ye Çeviri ve Adaptasyonu. Turkish Jour
Primary Completion
July 1, 2025
Actual (reported)Study Completion
July 1, 2025
Actual (reported)Last Updated
August 17, 2025
Record last verified: 2025-08
Individual participant data (IPD) from this study, including de-identified demographic, clinical, and questionnaire data, will be available upon reasonable request after publication of the study results. Requests should be submitted to the corresponding author, who will evaluate the request for ethical and privacy compliance before sharing
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