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Účinky trojrozměrného cvičebního programu založeného na Schrothu na úhel kyfózy, síly svalů, rovnováhy, bolesti a kvality života u pacientů s posturální hyperkyfózou s chronickou bolestí krku (Kyphosis)

2. října 2026 aktualizováno: Baskent University

The normal thoracic kyphosis angle of the spine is 20-40°, however, an angle of more than 40° is referred to as postural kyphosis, increased kyphosis or hyperkyphosis. Although postural kyphosis negatively affects individuals' general health status, physical performance, and quality of life, there is still no standardized protocol for correcting the thoracic kyphosis angle. Conservative treatment approaches such as postural training and exercises, manual therapy, postural corrective kinesiotaping, and orthotic use have been recommended for managing increased thoracic kyphosis. While numerous studies have demonstrated the effectiveness of three-dimensional exercise programs in the treatment of scoliosis, research examining their impact on kyphosis remains considerably limited.Nevertheless, the potential of these exercises to promote neuromuscular reorganization suggests that they may be similarly effective in individuals with thoracic kyphosis. This randomized controlled trial aims to evaluate the effects of a Schroth-based three-dimensional exercise program on kyphosis angle, trunk muscle strength, balance, pain, and quality of life in individuals with postural hyperkyphosis and chronic neck pain.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

Increasing thoracic kyphosis, spinal extensor muscle weakness, decreased spinal extension mobility, lumbo-pelvic pain, muscle activation and displacement of the scapula with changing traction angles have been associated with postural changes. It is evident that such alterations in posture have a biomechanical effect on the cervical and lumbar vertebrae. The presence of thoracic dysfunction has been documented in individuals experiencing chronic neck pain. Increases in both the thoracic kyphosis angle and flexor posture have been demonstrated to result in anterior displacement of the central gravity line. Displacement of the body's centre of gravity anteriorly has the potential to exert adverse effects on postural control.The association between postural changes and spinal extensor muscle weakness, increased kyphotic posture, decreased spinal extension mobility, lumbo-pelvic pain, muscle activation and displacement of the scapula with changing traction angles has been demonstrated. These postural changes have been demonstrated to exert a detrimental effect on postural stability, back pain, physical performance and quality of life.

The present study was meticulously designed as a Schroth-based three-dimensional exercise group and a control group, with a duration of eight weeks. The two groups will both undergo a programme comprising 20 sessions of electrotherapy and exercise, to be administered over a period of four weeks. Subsequent to the completion of the fourth week of electrotherapy sessions, the exercise applications will be continued for a further four weeks by the physiotherapist responsible for the study, who will undertake the programme three days per week. The intervention will consist of a series of educational sessions focusing on the development of postural perception, with a particular emphasis on the identification of postural kyphosis and the adoption of optimal posture in daily living. These educational sessions will be administered to both groups. The training programme will be delivered in a practical manner by the physiotherapist. A brochure will be provided to patients, serving as a reference guide for the exercises and considerations.

Typ studie

Intervenční

Zápis (Odhadovaný)

52

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Çankaya
      • Ankara, Çankaya, Turecko (Türkiye), 06800
        • Baskent University Umitkoy Outpatient Clinic

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

20 let až 50 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Thoracic kyphosis angle > 45 degrees,
  • Aged between 20 and 50 years,
  • Have neck pain for more than 3 months,
  • Neck pain visual analogue scale > 3,
  • Not being treated for postural kyphosis in the last 6 months,
  • Has no systemic disease

Exclusion Criteria:

  • History of trauma or surgery on spinal joints,
  • Participants with rheumatological and metabolic disorders,
  • Participants with congenital postural deformity and scoliosis

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: three-dimensional schroth exercise group

Schroth therapy, a three-dimensional exercise therapy program was developed in Germany in the 1920s by Katharina Schroth. The three-dimensional exercise program refers to the sagittal, frontal and horizontal planes. The three- dimensional Schroth exercise training consists of spinal lengthening and positional correction of the cervical, thoracic and lumbar regions in the sagittal plane, special breathing techniques and re-education of the neuromuscular system to improve kyphotic posture.

The study group will receive electrotherapy treatment (hot pack, ultrasound, tens) to the neck area for 30 minutes in each session. After electrotherapy treatment, kyphotic posture correction exercises will be applied with the help of proprioceptive and extroceptive stimuli in the sagittal plane with mirror control and specific corrective breathing. In the exercise program, exercise practices will be performed in specific positions in supine, prone, sitting and standing. The exercise program will be planned for approximately 40 minutes in each session. A total of 20 sessions of electrotherapy and exercise will be performed for 4 weeks. At the end of the 4th week, after the electrotherapy sessions are completed, exercise applications will continue for the other 4 weeks by the physiotherapist who performs the exercise 3 days a week.

Aktivní komparátor: corrective exercises for posture

Corrective exercise program for posture will consist of deep neck flexor muscle strengthening exercises, lower and middle trapezius strengthening, neck isometric exercises.

Patients to be included in the control group will receive electrotherapy treatment (ultrasound, tens, hotpack) to the neck area for 30 minutes in each session. After the electrotherapy treatment, posture corrective exercises will be applied. Corrective exercise program for posture will consist of deep neck flexor muscle strengthening exercises, lower and middle trapezius strengthening, neck isometric exercises. All strengthening exercises will be given 3 sets of 10 repetitions per day, each repetition for 10 seconds. Stretching exercises will be given to the shortened upper trapezius and pectoralis major muscles. Stretching exercises will be given 2 sets of 5 repetitions per day, with each repetition lasting 20 seconds. In the first 4 weeks, a total of 20 sessions of electrotherapy and exercise will be performed in corrective exercises for posture. At the end of the 4th week, exercise applications will continue for the other 4 weeks 3 days a week.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Angle of thoracic kyphosis
Časové okno: Baseline,4th week, 8th week

The kyphosis angles of the participants will be measured using a flexible ruler and an inclinometer.As stated in the literature, thoracic kyphosis will be measured from C7-T12 spinal processes.Prior to molding the flexicurve ruler to the subject's spine, the C7 and T12 posterior spinous processes were located via palpation.The flexicurve ruler was then molded over the spine midline from C7 to T12. The resulting curve was traced on paper, and the locations of the C7 and T12 processes were labelled. The measurement was performed while the participant stood in a neutral upright posture with feet shoulder-width apart.The flexible ruler will be placed on the marked reference points. It will then be placed on the millimetrically divided paper without distorting its shape. The angular value of the curvature drawn on the paper from the contour of the flexible ruler will then be calculated. Another kyphosis angle will be measured by the same procedure using an inclinometer.

Baseline,4th week, 8th week

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Trunk Muscle Strength
Časové okno: Baseline,4th week, 8th week

In our study, trunk extensor and flexor muscle strengths of participants will be measured with a hand-held dynamometer (Lafayette hand-held dynamometer model 01165 JTech, USA). Trunk extension strength will be measured in a prone position. The dynamometer will be positioned at the T4 level of the subjects, with the measurement being taken perpendicular to the body. Participants will be asked to assume the supine position with their knees straight, in order to measure the strength of their trunk flexor muscles. The dynamometer will be placed at the sternum level, and the measurement will be taken perpendicular to the trunk.Participants will be asked to cross their hands over their chest. In both measurements, participants are instructed to generate an isometric trunk extension force for a duration of two seconds, followed by a maximum isometric hold for five seconds. This measurement is then repeated on three occasions.

Baseline,4th week, 8th week
Balance Assessment
Časové okno: Baseline,4th week, 8th week

Tetrax posturography device (Tetrax Potable Multiple System, Tetrax Ltd., Ramat Gan, Israel) is a device that allows objective assessment and recording of postural stability and fall risk.The measurements will be conducted in eight different positions: eyes open and closed with the head in a neutral position, eyes open and closed while standing on a foam surface with the head in a neutral position, eyes closed with the head rotated to the right and left, and eyes closed with the neck in full extension and flexion positions. The general stability index (SI) is to be conducted, with the displacement of each case's centre of mass and anterior-posterior weight distribution measurements being the basis on which it is to be assessed.

Baseline,4th week, 8th week
Spinal Stabilisation Activity
Časové okno: Baseline,4th week, 8th week

The assessment of spinal stabilisation activity will be conducted utilising the Stabiliser Pressure Biofeedback device (PBU; Chattanooga Group-Australia).The pressure biofeedback device is a practical tool commonly used in clinical settings to measure the pressure generated during the activation of the Transversus Abdominis and Multifidus muscles, emphasizing segmental stabilization. The pressure gauge of the device ranges from 0 to 200 mmHg and is connected to an inflation unit (manometer). The measurement will be conducted with the patient in the prone position. The inflation unit of the device will be placed under the patient's umbilicus, positioned above the ASIS (anterior superior iliac spines). Before asking the patient to perform any muscle movement, the device's pressure will be set to 70 mmHg. Participants will be instructed to take a deep breath and gently draw the umbilicus toward the lumbar vertebrae, maintaining this position for 10 seconds

Baseline,4th week, 8th week
Visual Analogue Scale (VAS)
Časové okno: Baseline,4th week, 8th week

The VAS (Visual Analogue Scale) will be utilised to evaluate the severity of neck pain. The patient will be requested to indicate the intensity of discomfort experienced over the preceding seven days on a 10-centimetre ruler that has been segmented into equal divisions. A score of 0 indicates an absence of pain, while a score of 10 represents the most severe pain. The measurement results will be used to assess the pain intensity.

Baseline,4th week, 8th week
Occiput Wall and Tragus Wall Distance
Časové okno: Baseline,4th week, 8th week

To determine the anterior tilt of the head, the Tragus-to-Wall Distance will be measured. The participants should stand upright with their heels and back against the wall, maintaining a neutral neck position and closed chin. The distances between the occiput and the wall, as well as the tragus and the wall, will be measured using a tape measure in the sagittal plane. The average of these two measurements will then be calculated and recorded in centimetres.

Baseline,4th week, 8th week
Neck Disability Index
Časové okno: Baseline,4th week, 8th week

The Neck Disability Index (NDI) is a self-reported questionnaire designed to assess neck pain-related disability. It consists of 10 items addressing daily activities such as personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration, and headache. Each item is scored on a 6-point Likert scale ranging from 0 (no disability) to 5 (complete disability). The total score is calculated by summing the scores of all items and multiplying by two, resulting in a final score ranging from 0 to 100, where higher scores indicate a greater level of disability. In this study, the NDI will be used to evaluate neck-related functional limitations of participants, with scores expressed as a percentage of maximum possible disability.

Baseline,4th week, 8th week
Assessment of Quality of Life
Časové okno: Baseline,4th week, 8th week

The Scoliosis Research Society-22 (SRS-22) Questionnaire is a widely accepted, simple, and practical tool developed by the Scoliosis Research Society to assess health-related quality of life in individuals with spinal deformities. In this study, the SRS-22 will be used to evaluate the quality of life of participants. The The questionnaire consists of 22 items grouped into five domains: pain, self-image/appearance, function/activity, mental health, and satisfaction with treatment. Each item is scored on a 5-point Likert scale, ranging from 1 (worst outcome) to 5 (best outcome). The total score is calculated by averaging the item scores within each domain or across all items. Higher scores reflect better health-related quality of life.

Baseline,4th week, 8th week

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spolupracovníci

Vyšetřovatelé

  • Studijní židle: Tuğçe BAYRAM ERKOYUNCU, Baskent University
  • Ředitel studie: Hayri Baran YOSMAOĞLU, Prof., Baskent University
  • Vrchní vyšetřovatel: Selin ÖZEN, Assoc. prof., Baskent University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

25. února 2025

Primární dokončení (Aktuální)

23. září 2026

Dokončení studie (Odhadovaný)

23. května 2027

Termíny zápisu do studia

První předloženo

14. února 2025

První předloženo, které splnilo kritéria kontroly kvality

14. února 2025

První zveřejněno (Aktuální)

19. února 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. října 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. října 2026

Naposledy ověřeno

1. října 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • KA24/125

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

There are no plans to share individual participant data (IPD). However, once statistical analyses of all data are completed, aggregated results and summary statistical findings will be made available to researchers. These results will be shared in a de-identified format to ensure participant privacy. Interested researchers can request access to the results by contacting the principal investigator at (bayramtugce91@gmail.com)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .