The Effect of Postural Biofeedback on Disease Activity and Pain in Individuals With Axial Spondyloarthritis
| Registry | NCT07776652 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 38 (Estimated) |
| Sponsor | Istanbul University - Cerrahpasa (Other) |
| Conditions | Axial Spondyloarthritis (AxSpA), Ankylosing Spondylitis (AS) |
| Interventions | Standard Exercise Program, Wearable Postural Biofeedback (Behavioral) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-05-30 (estimated), completion 2027-06-30 (estimated), first posted 2026-08-20, last updated 2026-08-21 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Axial Spondyloarthritis (AxSpA) All trials for Ankylosing Spondylitis (AS) All trials of Standard Exercise Program All trials of Wearable Postural Biofeedback
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control Group | Active comparator | Behavioral: Standard Exercise Program | 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. |
| Postural Biofeedback Group | Experimental | Behavioral: Standard Exercise Program; Behavioral: Wearable Postural Biofeedback | 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. |
Sex: All, ages: 18 Years to 65 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Istanbul University-Cerrahpasa, Faculty of Health Sciences | Istanbul, Istanbul | Turkey (Türkiye) |