- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07627542
An Investigation of the Effect of Smartphone Usage Levels on Cervical Posture, Tongue Pressure, Balance, and Neck Disability in Individuals With Rheumatoid Arthritis and Ankylosing Spondylitis
Přehled studie
Postavení
Detailní popis
This study is designed as a cross-sectional, comparative, and correlational investigation conducted at the Necmettin Erbakan University Faculty of Medicine Hospital, Rheumatology Outpatient Clinic. The study population will consist of three groups, each comprising 37 participants (Total N = 111): the Rheumatoid Arthritis (RA) group, the Ankylosing Spondylitis (AS) group, and a Healthy Control (HC) group. Participants will be recruited using consecutive sampling according to their eligibility.
Following the written informed consent process in accordance with the Declaration of Helsinki, a single-session comprehensive assessment protocol will be conducted by an experienced physiotherapist. No therapeutic interventions or follow-up procedures will be performed.
The structured evaluation protocol will be executed in the following chronological order:
- Sociodemographic and Descriptive Information Form: Participants will be questioned regarding age, sex, height, body weight, marital status, educational level, smoking habits, medical history, disease duration, active medications, sports participation, daily smartphone/computer/tablet usage duration, and habitual posture/ergonomics during technology use.
- Neck Disability Index (NDI): Symptoms and functional limitations will be evaluated using the Turkish validated version of the NDI (Aslan & Karaduman, 2009). Scoring ranges from 0 to 50, where higher scores indicate greater functional disability.
- Smartphone Addiction Scale-Short Version (SAS-SV): Technological dependency will be assessed using the Turkish validated version of the SAS-SV (Noyan et al., 2015). Cut-off values of 31 for males and 33 for females will be utilized to determine addiction status.
- Craniovertebral Angle (CVA) Measurement: To objectively assess forward head posture, goniometric measurement will be performed. Anatomical reference points (the spinous process of the C7 vertebra and the tragus of the ear) will be marked. The goniometer center will be aligned with C7, with the stationary arm perpendicular to the ground and the movable arm aligned with the tragus. The average of three measurements with 2-minute rest intervals will be recorded. A CVA below 50° indicates Text Neck/forward head posture.
- Neck Extensor Muscle Strength Test: While the participant sits upright, a digital handheld dynamometer probe will be placed at the occipital protuberance. Participants will perform a maximal isometric contraction pushing backward against the probe. The average of three trials with 30-60 second rest intervals will be recorded in Newtons (N).
- Single-Leg Stance Test (SLST): Static balance performance will be evaluated on the non-dominant leg (stabilizing limb). The test will be performed three times with eyes open and three times with eyes closed, with a ceiling effect set at 60 seconds. The best scores will be recorded in seconds.
- Pressure Pain Threshold (PPT) via Algometry: A digital algometer will be applied perpendicularly to the midpoint of the upper trapezius muscle and the suboccipital region. Pressure will be increased until the participant experiences the first sensation of pain. Two or three measurements will be averaged with 1-minute intervals to ensure reliability.
- Tongue Pressure Assessment via IOPI: To evaluate the motor control of swallowing and suprahyoid muscle activity, the Iowa Oral Pressure Instrument (IOPI) will be utilized. An air-filled tongue bulb will be placed on the midline of the hard palate. Participants will press the bulb maximally against the palate for 5 seconds. The maximum value of three trials with 2-minute rest intervals will be recorded in Kilopascals (kPa).
Statistical analyses will be conducted to evaluate the negative correlations between smartphone addiction and functional parameters (CVA, muscle strength, PPT, balance, and tongue pressure), positive correlations with NDI, and to compare the physical deterioration between the clinical groups and healthy controls.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Fatma ERDEO, Assistant Professor
- Telefonní číslo: +90505 443 17 78
- E-mail: ferdeo@erbakan.edu.tr
Studijní záloha kontaktů
- Jméno: Merve ŞAHİN, PT
- Telefonní číslo: +905528255101
- E-mail: mervesahin5101@gmail.com
Studijní místa
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Meram
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Konya, Meram, Turecko (Türkiye), 42090
- Nábor
- Necmettin Erbakan University Faculty of Medicine Hospital, Rheumatology Outpatient Clinic
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Kontakt:
- Merve ŞAHİN, PT
- Telefonní číslo: +905528255101
- E-mail: mervesahin5101@gmail.com
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Kontakt:
- Mustafa Ç ERGÜN, MD, Assistant Professor
- Telefonní číslo: +905055272690
- E-mail: bilgi@erbakan.edu.tr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Aged 18 to 65 years.
- Using a smartphone for at least 2 hours daily.
- Able to understand and follow postural commands during clinical measurements.
- For the Rheumatoid Arthritis (RA) Group: Diagnosed with RA by a rheumatologist, with a stable disease activity score (DAS28 < 3.2).
- For the Ankylosing Spondylitis (AS) Group: Diagnosed with AS by a rheumatologist, with a stable disease activity score (BASDAI < 4).
Exclusion Criteria:
- History of prior surgical intervention in the cervical region.
- Presence of neurological diseases (e.g., Parkinson's disease, ALS).
- Severe visual or hearing impairment.
- Vestibular system disorders.
- Severe limitation in jaw opening.
- Presence of acute neck trauma or malignancy.
- Lower extremity amputation or advanced arthritis that prevents performing the balance test.
- Active use of muscle relaxants or advanced sedative medications.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Rheumatoid Arthritis (RA) Group
Patients diagnosed with Rheumatoid Arthritis by a rheumatologist, with a stable disease activity score (DAS28 < 3.2), aged 18-65, and using a smartphone for at least 2 hours daily.
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Ankylosing Spondylitis (AS) Group
Patients diagnosed with Ankylosing Spondylitis by a rheumatologist, with a stable disease activity score (BASDAI < 4), aged 18-65, and using a smartphone for at least 2 hours daily.
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Healthy Control Group
Healthy individual volunteers aged 18-65 with no history of rheumatological, neurological, or chronic musculoskeletal diseases, and using a smartphone for at least 2 hours daily.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Smartphone Addiction Scale-Short Version (SAS-SV)
Časové okno: At baseline (Single assessment session)
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The SAS-SV is a 10-item self-reported questionnaire used to evaluate the level of smartphone dependency.
Each item is rated on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree).
Total scores range from 10 to 60.
The cutoff scores were determined to be 31 for men and 33 for women, with higher scores indicating a higher risk and severity of smartphone addiction.
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At baseline (Single assessment session)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Neck Disability Index (NDI)
Časové okno: At baseline (Single assessment session)
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The NDI is a 10-item questionnaire measuring neck pain-related disability and its impact on functional activities.
Each item is scored from 0 (no disability) to 5 (total disability).
Total scores range from 0 to 50, where higher scores represent greater functional neck impairment and disability.
(0-4 points: no disability, 5-14 points: mild disability, 15-24 points: moderate disability, 25-34 points: severe disability, 35 points and above: complete disability)
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At baseline (Single assessment session)
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Craniovertebral Angle (CVA)
Časové okno: At baseline (Single assessment session)
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CVA will be measured in degrees using a manual goniometer to objectively assess forward head posture.
The center of the goniometer will be placed on the C7 spinous process, with one arm vertical to the ground and the other pointing to the tragus of the ear.
The average of three trials will be recorded.
A lower angle indicates a greater severity of forward head posture (cutoff value is 50°).
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At baseline (Single assessment session)
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Single-Leg Stance Test (SLST) Performance
Časové okno: At baseline (Single assessment session)
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Static balance performance will be evaluated on the non-dominant leg with eyes open and eyes closed.
The duration the participant maintains balance will be recorded in seconds, with a maximum ceiling effect of 60 seconds.
Higher durations indicate better static balance stability.
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At baseline (Single assessment session)
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Neck Extensor Muscle Strength
Časové okno: At baseline (Single assessment session)
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Neck extensor strength will be evaluated using a digital handheld dynamometer placed at the level of the occipital protuberance while the participant sits upright.
Participants will perform three maximal isometric contractions pushing backward, and the average value will be recorded in Newtons (N).
Higher values indicate better muscle strength.
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At baseline (Single assessment session)
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Pressure Pain Threshold (PPT)
Časové okno: At baseline (Single assessment session)
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The PPT will be measured using a digital algometer applied perpendicularly to the midpoint of the upper trapezius muscle and the suboccipital region.
Pressure will be increased gradually, and the value at which the participant feels the first sensation of pain will be recorded in kg/cm².
Higher threshold values indicate less pain sensitivity.
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At baseline (Single assessment session)
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Maximum Tongue Pressure
Časové okno: At baseline (Single assessment session)
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Maximum isometric tongue pressure will be evaluated using the Iowa Oral Pressure Instrument (IOPI).
Participants will press an air-filled rubber bulb placed at the midline of the hard palate as hard as possible for 5 seconds.
The maximum value of three trials will be recorded in Kilopascals (kPa).
Higher values represent greater tongue muscle strength.
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At baseline (Single assessment session)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Fatma ERDEO, Assistant Professor, Necmettin Erbakan University Faculty of Health Sciences
Publikace a užitečné odkazy
Obecné publikace
- Bennett JL, Pratt AG, Dodds R, Sayer AA, Isaacs JD. Rheumatoid sarcopenia: loss of skeletal muscle strength and mass in rheumatoid arthritis. Nat Rev Rheumatol. 2023 Apr;19(4):239-251. doi: 10.1038/s41584-023-00921-9. Epub 2023 Feb 17.
- Ahmed EA, Atar S, Atar Y, Sari H, Anarat MEA, Salturk Z, Karaketir SG, Uyar Y, Kuru O. Evaluation of the Swallowing and Voice Functions in Ankylosing Spondylitis Patients. Dysphagia. 2022 Apr;37(2):455-462. doi: 10.1007/s00455-021-10340-1. Epub 2021 Jul 14.
- Castien RF, van der Wouden JC, De Hertogh W. Pressure pain thresholds over the cranio-cervical region in headache: a systematic review and meta-analysis. J Headache Pain. 2018 Jan 26;19(1):9. doi: 10.1186/s10194-018-0833-7.
- Portelli A, Reid SA. Cervical Proprioception in a Young Population Who Spend Long Periods on Mobile Devices: A 2-Group Comparative Observational Study. J Manipulative Physiol Ther. 2018 Feb;41(2):123-128. doi: 10.1016/j.jmpt.2017.10.004. Epub 2018 Jan 17.
- Ulutatar F, Unal-Ulutatar C, Duruoz MT. Cervical proprioceptive impairment in patients with rheumatoid arthritis. Rheumatol Int. 2019 Dec;39(12):2043-2051. doi: 10.1007/s00296-019-04419-0. Epub 2019 Aug 21.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Axiální spondylartritida
- Závislost na technologii
- Bolest
- Neurologické projevy
- Nemoci kostí
- Nemoci pohybového aparátu
- Artritida
- Onemocnění kloubů
- Revmatická onemocnění
- Nemoci pojivové tkáně
- Autoimunitní onemocnění
- Onemocnění imunitního systému
- Nemoci páteře
- Spondylartropatie
- Ankylóza
- Spondylartritida
- Spondylitida
- Chování, návykové
- Kompulzivní chování
- Impulzivní chování
- Patologické stavy, příznaky a symptomy
- Chování
- Onemocnění kůže a pojivové tkáně
- Příznaky a symptomy
- Porucha závislosti na internetu
- Spondylitida, ankylozující
- Artritida, revmatoidní
- Bolest krku
Další identifikační čísla studie
- 30246.R1
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