Postural Biofeedback and Exercise in Axial Spondyloarthritis

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard Exercise Program: 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.

Wearable Postural Biofeedback: 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.

Study summary

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

Eligibility

Primary outcome measure(s)

• Change in Disease Activity Assessed by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) — Baseline to Week 8
  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.

Trial sites (1)

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