Postural Biofeedback and Exercise in Axial Spondyloarthritis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul University - Cerrahpasa
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Exercise Program
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Postural Biofeedback GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 8Secondary outcomes
1
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 82
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 83
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 84
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 8Sponsors and contacts
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Source ClinicalTrials.gov
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