Postural Biofeedback and Exercise in Axial Spondyloarthritis
19 августа 2026 г. обновлено: Melike Nur CAN, Istanbul University - Cerrahpasa
The Effect of Postural Biofeedback on Disease Activity and Pain in Individuals With Axial Spondyloarthritis
The goal of this clinical trial is to learn whether adding a wearable postural biofeedback device to a standard exercise program affects disease activity, pain, and functional parameters in individuals with axial spondyloarthritis. The main questions it aims to answer are:
Does adding postural biofeedback to a standard exercise program improve disease activity? Does adding postural biofeedback to a standard exercise program reduce pain? Does adding postural biofeedback improve functional parameters, including spinal mobility, quality of life, posture, and functional exercise capacity?
Researchers will compare a standard exercise program with the same exercise program combined with a wearable postural biofeedback device to determine whether the addition of postural biofeedback provides greater benefits.
Participants will:
Participate in a physiotherapist-supervised standard exercise program twice a week for 8 weeks Use the wearable postural biofeedback device three days per week for at least 3 hours per day during prolonged static posture activities if assigned to the intervention group Complete assessments before and after the 8-week intervention, including measures of disease activity, pain, physical function, spinal mobility, quality of life, posture, and functional exercise capacity
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
38
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Melike N Can, PT
- Номер телефона: +905449051387
- Электронная почта: melikenrcan@gmail.com
Места учебы
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Istanbul
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Istanbul, Istanbul, Турция (Туркие), 34500
- Istanbul University-Cerrahpasa, Faculty of Health Sciences
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Контакт:
- Melike N Can, PT
- Номер телефона: +905449051387
- Электронная почта: melikenrcan@gmail.com
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- Be between 18 and 65 years of age.
- Have a diagnosis of ankylosing spondylitis or axial spondyloarthritis according to the modified New York or ASAS classification criteria.
- Have had stable medical treatment with no changes in medication during the previous 3 months.
- Have axial/spinal pain intensity of at least 4 out of 10 on the Numeric Pain Rating Scale during the previous week.
- Be able to walk independently.
- Voluntarily agree to participate in the study and provide written informed consent.
Exclusion Criteria:
- History of spinal surgery within the previous 6 months.
- Any change in medical treatment, including biological agents or analgesic treatment, within the previous 3 months.
- Presence of fibromyalgia or another secondary chronic pain syndrome that may substantially affect pain perception.
- Serious cardiopulmonary, neurological, or orthopedic conditions that prevent participation in exercise.
- Pregnancy.
- Dermatological or allergic skin reactions or other skin conditions that prevent the use of the wearable device.
- Regular participation in a structured exercise or rehabilitation program supervised by a physiotherapist for axial spondyloarthritis within the previous 3 months.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: Control Group
Participants in the control group will receive a standard exercise program for 8 weeks.
The program will be supervised by a physiotherapist twice a week, with each session lasting approximately 45 minutes.
The program will include warm-up, spinal mobility exercises, stretching exercises, postural exercises, trunk stabilization exercises, lower extremity strengthening exercises, breathing exercises, and cool-down.
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Participants in both study groups will receive a standard exercise program for 8 weeks, with two physiotherapist-supervised sessions per week and approximately 45 minutes per session.
The program will include warm-up, spinal mobility exercises, stretching exercises, postural exercises, trunk stabilization exercises, lower extremity strengthening exercises, breathing exercises, and cool-down.
Exercises will be performed at moderate intensity according to the participant's clinical condition and exercise tolerance.
Set number, repetitions, and resistance will be progressively increased by the physiotherapist according to individual performance.
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Экспериментальный: Postural Biofeedback Group
Participants in the intervention group will receive the same standard exercise program as the control group for 8 weeks, supervised by a physiotherapist twice a week for approximately 45 minutes per session.
In addition, participants will use a wearable postural biofeedback device (Kodgem Straight™, Türkiye) three days per week for at least 3 hours per day during activities requiring prolonged static posture.
The device will provide vibrotactile feedback when a predefined postural threshold is exceeded.
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Participants in both study groups will receive a standard exercise program for 8 weeks, with two physiotherapist-supervised sessions per week and approximately 45 minutes per session.
The program will include warm-up, spinal mobility exercises, stretching exercises, postural exercises, trunk stabilization exercises, lower extremity strengthening exercises, breathing exercises, and cool-down.
Exercises will be performed at moderate intensity according to the participant's clinical condition and exercise tolerance.
Set number, repetitions, and resistance will be progressively increased by the physiotherapist according to individual performance.
Participants in the intervention group will additionally use a wearable postural biofeedback device (Kodgem Straight™, Türkiye) for 8 weeks.
The device uses inertial sensors to monitor the position of the upper thoracic region in real time and provides vibrotactile feedback when a predefined postural threshold is exceeded.
The device will be individually calibrated before use.
Participants will be instructed to use the device three days per week for at least 3 hours per day during activities requiring prolonged static posture, such as desk work, computer use, meal preparation, or ironing.
Device adherence will be monitored and recorded by the researcher.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Disease Activity Assessed by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Временное ограничение: Baseline to Week 8
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Disease activity will be assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
The BASDAI consists of 6 items assessing fatigue, axial pain, peripheral joint pain or swelling, localized tenderness, and the severity and duration of morning stiffness.
Each item is scored from 0 to 10, with higher scores indicating greater disease activity.
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Baseline to Week 8
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Axial Pain Intensity Assessed by the Numeric Rating Scale (NRS)
Временное ограничение: Baseline to Week 8
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Axial/spinal pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable).
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Baseline to Week 8
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Change in Functional Status Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
Временное ограничение: Baseline to Week 8
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Functional limitations in daily activities will be assessed using the 10-item BASFI.
Scores range from 0 to 10, with higher scores indicating greater functional limitation.
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Baseline to Week 8
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Change in Spinal Mobility Assessed by the Bath Ankylosing Spondylitis Metrology Index (BASMI)
Временное ограничение: Baseline to Week 8
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Spinal mobility will be assessed using the BASMI, which includes tragus-to-wall distance, modified Schober test, lumbar lateral flexion, intermalleolar distance, and cervical rotation.
Higher scores indicate greater limitation in spinal mobility.
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Baseline to Week 8
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Change in Health-Related Quality of Life Assessed by the Ankylosing Spondylitis Quality of Life Scale (ASQoL)
Временное ограничение: Baseline to Week 8
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Disease-specific health-related quality of life will be assessed using the 18-item ASQoL.
Scores range from 0 to 18, with higher scores indicating poorer quality of life.
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Baseline to Week 8
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Change in Postural Alignment Assessed by the New York Posture Assessment Method
Временное ограничение: Baseline to Week 8
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Postural alignment will be assessed observationally in the frontal and sagittal planes, including the head, shoulders, spine, pelvis, hips, knees, and ankles.
Higher total scores indicate better postural alignment.
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Baseline to Week 8
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Change in Functional Exercise Capacity Assessed by the Two-Minute Walk Test
Временное ограничение: Baseline to Week 8
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Functional exercise capacity will be assessed by the total distance walked in meters during a 2-minute walk test on a 30-meter walking course.
A greater walking distance indicates better functional exercise capacity.
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Baseline to Week 8
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Global Perceived Change Assessed by the Global Rating of Change Scale (GROC)
Временное ограничение: Week 8
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Participants' perceived overall improvement will be assessed using the Global Rating of Change Scale, ranging from -7 (very much worse) to +7 (very much better).
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Week 8
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Perceived Usability of the Wearable Postural Biofeedback Device Assessed by the System Usability Scale (SUS)
Временное ограничение: Week 8
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Perceived usability of the wearable postural biofeedback device will be assessed using the 10-item System Usability Scale.
The SUS is scored on a 0-100 scale, with higher scores indicating better perceived usability.
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Week 8
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Gossec L, Guyard F, Leroy D, Lafargue T, Seiler M, Jacquemin C, Molto A, Sellam J, Foltz V, Gandjbakhch F, Hudry C, Mitrovic S, Fautrel B, Servy H. Detection of Flares by Decrease in Physical Activity, Collected Using Wearable Activity Trackers in Rheumatoid Arthritis or Axial Spondyloarthritis: An Application of Machine Learning Analyses in Rheumatology. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1336-1343. doi: 10.1002/acr.23768.
- Coulter EH, McDonald MT, Cameron S, Siebert S, Paul L. Physical activity and sedentary behaviour and their associations with clinical measures in axial spondyloarthritis. Rheumatol Int. 2020 Mar;40(3):375-381. doi: 10.1007/s00296-019-04494-3. Epub 2019 Dec 17.
- Thomassen EEK, Tveter AT, Berg IJ, Kristianslund EK, Reiner A, Hakim S, Gossec L, J Macfarlane G, de Thurah A, Osteras N. Feasibility of Long-Term Physical Activity Measurement With a Wearable Activity Tracker in Patients With Axial Spondyloarthritis: 1-Year Longitudinal Observational Study. JMIR Hum Factors. 2025 May 7;12:e68645. doi: 10.2196/68645.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 октября 2026 г.
Первичное завершение (Оцененный)
30 мая 2027 г.
Завершение исследования (Оцененный)
30 июня 2027 г.
Даты регистрации исследования
Первый отправленный
18 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
18 августа 2026 г.
Первый опубликованный (Действительный)
20 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
21 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
19 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- kHo7h153
Планирование данных отдельных участников (IPD)
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НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .