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NCT07776652
Postural Biofeedback and Exercise in Axial Spondyloarthritis
Conditions: Axial Spondyloarthritis (AxSpA), Ankylosing Spondylitis (AS)
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 38
Sponsor: Istanbul University - Cerrahpasa
Location: Istanbul University-Cerrahpasa, Faculty of Health Sciences Istanbul Istanbul
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07776652). StuddyBuddy aggregates publicly available trial information.