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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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.
Istanbul University-Cerrahpasa, Faculty of Health Sciences
Istanbul, Istanbul, Turkey (Türkiye)
Change in Disease Activity Assessed by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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.
Time frame: Baseline to Week 8
Change in Axial Pain Intensity Assessed by the Numeric Rating Scale (NRS)
Axial/spinal pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline to Week 8
Change in Functional Status Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
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.
Time frame: Baseline to Week 8
Change in Spinal Mobility Assessed by the Bath Ankylosing Spondylitis Metrology Index (BASMI)
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.
Time frame: Baseline to Week 8
Change in Health-Related Quality of Life Assessed by the Ankylosing Spondylitis Quality of Life Scale (ASQoL)
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.
Time frame: Baseline to Week 8
Change in Postural Alignment Assessed by the New York Posture Assessment Method
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.
Time frame: Baseline to Week 8
Change in Functional Exercise Capacity Assessed by the Two-Minute Walk Test
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.
Time frame: Baseline to Week 8
Global Perceived Change Assessed by the Global Rating of Change Scale (GROC)
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).
Time frame: Week 8
Perceived Usability of the Wearable Postural Biofeedback Device Assessed by the System Usability Scale (SUS)
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.
Time frame: Week 8
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