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NCT Number: NCT07776652

Postural Biofeedback and Exercise in Axial Spondyloarthritis

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

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Key information

Conditions

Axial Spondyloarthritis (AxSpA) Ankylosing Spondylitis (AS) Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa, Faculty of Health Sciences

Istanbul, 34500, Turkey (Türkiye)

Location contact

Melike N Can, PT

CONTACT

[email protected]

+905449051387

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Exercise Program

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change in Disease Activity Assessed by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: 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.

Secondary outcomes

  1. Change in Axial Pain Intensity Assessed by the Numeric Rating Scale (NRS)

    Time frame: Baseline to Week 8

    Axial/spinal pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable).

  2. Change in Functional Status Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: Baseline to Week 8

    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.

  3. Change in Spinal Mobility Assessed by the Bath Ankylosing Spondylitis Metrology Index (BASMI)

    Time frame: Baseline to Week 8

    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.

  4. Change in Health-Related Quality of Life Assessed by the Ankylosing Spondylitis Quality of Life Scale (ASQoL)

    Time frame: Baseline to Week 8

    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.

  5. Change in Postural Alignment Assessed by the New York Posture Assessment Method

    Time frame: Baseline to Week 8

    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.

  6. Change in Functional Exercise Capacity Assessed by the Two-Minute Walk Test

    Time frame: Baseline to Week 8

    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.

  7. Global Perceived Change Assessed by the Global Rating of Change Scale (GROC)

    Time frame: Week 8

    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).

  8. Perceived Usability of the Wearable Postural Biofeedback Device Assessed by the System Usability Scale (SUS)

    Time frame: Week 8

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melike N Can, PT

CONTACT

[email protected]

+905449051387

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Effect of Postural Biofeedback on Disease Activity and Pain in Individuals With Axial Spondyloarthritis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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