Restless Legs Syndrome and Sleep Quality in Pes Planus

NCT07117591 | Completed

• 1 other identifier: 2024/21
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Restless Legs Syndrome; Sleep Quality; Pain; Quality of Life; Pes Planus; Depression

Keywords

Pes Planus; Restless Legs Syndrome; Sleep Disturbance; Foot Pain; Anxiety; Depression; Quality of Life; Foot Function

Outcome Measures

Primary Outcomes (3)

• 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).

  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

Secondary Outcomes (3)

• The Foot Function Index

  At baseline

• The Hospital Anxiety and Depression Scale

  At baseline

• SF-36

  At baseline

Study Arms (2)

Patient group

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.

the Control group

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age between 18 and 65 years
• Clinical diagnosis of pes planus by a physical medicine and rehabilitation specialist (for patient group)
• Ability to understand and provide written informed consent
• For control group: healthy individuals matched by age and sex without pes planus or leg pain

You may not qualify if:

• History of diabetes mellitus, hypothyroidism, chronic renal failure, neuropathic disorders, vasculitis, lumbar disc disease
• Previous foot fracture or surgery
• Rheumatologic diseases affecting pain perception (e.g., rheumatoid arthritis, ankylosing spondylitis, fibromyalgia)
• Significant circulatory disorders in lower extremities
• Undergoing chemotherapy or radiotherapy
• Cognitive impairment preventing questionnaire completion

Sponsors & Collaborators

• Bozok University: lead
• Ankara Etlik City Hospital: collaborator
• Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital: collaborator

Study Sites (1)

Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (6)

• Kocyigit H (1999) Turkish validity and reliability of short-form 36. Drug Treat 12:102-106

  BACKGROUND

• Ağargün MY (1996) Validity and reliability of Turkish version of Pittsburgh Sleep Quality Index. Türk Psikiyatri Dergisi 7:107

  BACKGROUND

• 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

  BACKGROUND

• Ay E (2017) Huzursuz bacaklar sendromunda kullanılan uluslararası huzursuz bacaklar sendromu çalışma grubu şiddet ölçeğinin türkçe geçerlilik ve güvenilirliğinin araştırılması. In. Sağlık Bilimleri Enstitüsü.

  BACKGROUND

• 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.

  PMID: 25023924 BACKGROUND

• YALIMAN A, ŞEN Eİ, ESKİYURT N, BUDIMAN-MAK E (2014) Ayak Fonksiyon İndeksi'nin Plantar Fasiitli Hastalarda Türkçe'ye Çeviri ve Adaptasyonu. Turkish Jour

  BACKGROUND

MeSH Terms

Conditions

Restless Legs Syndrome; Sleep Initiation and Maintenance Disorders; Pain; Flatfoot; Depression; Parasomnias; Anxiety Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavioral Symptoms; Behavior

Study Officials

• Gülseren Demir Karakılıç, Asst Prof

  Yozgat Bozok University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: December 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IPD and supporting documents will be available starting from the date of publication of the study results and will remain available for at least five years.
• Access Criteria: Access to the IPD and supporting information will be granted to qualified researchers upon submission of a reasonable request explaining the research purpose. The corresponding author and ethics committee will review the requests to ensure compliance with ethical standards and protection of participant confidentiality. Data will be shared via secure data transfer methods after signing a data use agreement.

Locations

TU (1)