Axial Spondyloarthritis (AxSpA)NCT07776652
Postural Biofeedback and Exercise in Axial Spondyloarthritis
A study testing Standard Exercise Program and Wearable Postural Biofeedback in people with Axial Spondyloarthritis (AxSpA) and Ankylosing Spondylitis (AS), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Axial Spondyloarthritis (AxSpA), Ankylosing Spondylitis (AS)
- What is being tested?
- Standard Exercise Program and Wearable Postural Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Faculty of Health Sciences
Istanbul, Istanbul, 34500
Melike N Can, PT, +905449051387, melikenrcan@gmail.com
About this study
Official title: The Effect of Postural Biofeedback on Disease Activity and Pain in Individuals With 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?
Read more
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
- Being tested
- Standard Exercise Program, Wearable Postural Biofeedback
- Keywords
- Axial Spondyloarthritis, Biofeedback, Postural Biofeedback, Exercise Therapy, Posture, Disease Activity
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Exercise ProgramBehavioural
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 BiofeedbackBehavioural
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 group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Behavioral: Standard Exercise Program |
| Postural Biofeedback Group | Experimental | 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. Receives: Behavioral: Standard Exercise Program; Behavioral: Wearable Postural Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 8
Secondary outcomes (8)
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).
Measured: Baseline to Week 8
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.
Measured: Baseline to Week 8
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.
Measured: Baseline to Week 8
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.
Measured: Baseline to Week 8
Change in Postural Alignment Assessed by the New York Posture Assessment Method
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.
Measured: Baseline to Week 8
Change in Functional Exercise Capacity Assessed by the Two-Minute Walk Test
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.
Measured: Baseline to Week 8
Global Perceived Change Assessed by the Global Rating of Change Scale (GROC)
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).
Measured: Week 8
Perceived Usability of the Wearable Postural Biofeedback Device Assessed by the System Usability Scale (SUS)
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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Axial Spondyloarthritis (AxSpA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups: a control group receiving a standard exercise program and an intervention group receiving the same standard exercise program combined with a wearable postural biofeedback device. Both groups will participate in the intervention for 8 weeks.
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Nur CAN, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776652
- Sponsor's protocol ID
- kHo7h153
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gossec L, Guyard F, Leroy D, Lafargue T, Seiler M, Jacquemin C, Molto A, Sellam J, Foltz V, Gandjbakhch F, Hudry C, Mitrovic S, Fautrel B, Servy H. Detection of Flares by Decrease in Physical Activity, Collected Using Wearable Activity Trackers in Rheumatoid Arthritis or Axial Spondyloarthritis: An Application of Machine Learning Analyses in Rheumatology. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1336-1343. doi: 10.1002/acr.23768.
PubMed 30242992Coulter EH, McDonald MT, Cameron S, Siebert S, Paul L. Physical activity and sedentary behaviour and their associations with clinical measures in axial spondyloarthritis. Rheumatol Int. 2020 Mar;40(3):375-381. doi: 10.1007/s00296-019-04494-3. Epub 2019 Dec 17.
PubMed 31848736Thomassen EEK, Tveter AT, Berg IJ, Kristianslund EK, Reiner A, Hakim S, Gossec L, J Macfarlane G, de Thurah A, Osteras N. Feasibility of Long-Term Physical Activity Measurement With a Wearable Activity Tracker in Patients With Axial Spondyloarthritis: 1-Year Longitudinal Observational Study. JMIR Hum Factors. 2025 May 7;12:e68645. doi: 10.2196/68645.
PubMed 40334280
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postural Biofeedback on Disease Activity and Pain in Individuals With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT07776652
- Acronym / sponsor ID
- kHo7h153
- Keywords
- Axial Spondyloarthritis, Biofeedback, Postural Biofeedback, Exercise Therapy, Posture, Disease Activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups: a control group receiving a standard exercise program and an intervention group receiving the same standard exercise program combined with a wearable postural biofeedback device. Both groups will participate in the intervention for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Standard Exercise ProgramParticipants 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 BiofeedbackParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Exercise ProgramParticipants 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. | Behavioural | Control Group, Postural Biofeedback Group |
| Wearable Postural BiofeedbackParticipants 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. | Behavioural | Postural Biofeedback Group |
Primary outcome
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.
8 secondary outcomes
Change in Axial Pain Intensity Assessed by the Numeric Rating Scale (NRS)
Time frame: Baseline to Week 8
Change in Functional Status Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: Baseline to Week 8
Change in Spinal Mobility Assessed by the Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: Baseline to Week 8
Change in Health-Related Quality of Life Assessed by the Ankylosing Spondylitis Quality of Life Scale (ASQoL)
Time frame: Baseline to Week 8
Change in Postural Alignment Assessed by the New York Posture Assessment Method
Time frame: Baseline to Week 8
Change in Functional Exercise Capacity Assessed by the Two-Minute Walk Test
Time frame: Baseline to Week 8
Global Perceived Change Assessed by the Global Rating of Change Scale (GROC)
Time frame: Week 8
Perceived Usability of the Wearable Postural Biofeedback Device Assessed by the System Usability Scale (SUS)
Time frame: Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 30242992Gossec L, Guyard F, Leroy D, Lafargue T, Seiler M, Jacquemin C, Molto A, Sellam J, Foltz V, Gandjbakhch F, Hudry C, Mitrovic S, Fautrel B, Servy H. Detection of Flares by Decrease in Physical Activity, Collected Using Wearable Activity Trackers in Rheumatoid Arthritis or Axial Spondyloarthritis: An Application of Machine Learning Analyses in Rheumatology. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1336-1343. doi: 10.1002/acr.23768.
- Background: PubMed 31848736Coulter EH, McDonald MT, Cameron S, Siebert S, Paul L. Physical activity and sedentary behaviour and their associations with clinical measures in axial spondyloarthritis. Rheumatol Int. 2020 Mar;40(3):375-381. doi: 10.1007/s00296-019-04494-3. Epub 2019 Dec 17.
- Background: PubMed 40334280Thomassen EEK, Tveter AT, Berg IJ, Kristianslund EK, Reiner A, Hakim S, Gossec L, J Macfarlane G, de Thurah A, Osteras N. Feasibility of Long-Term Physical Activity Measurement With a Wearable Activity Tracker in Patients With Axial Spondyloarthritis: 1-Year Longitudinal Observational Study. JMIR Hum Factors. 2025 May 7;12:e68645. doi: 10.2196/68645.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Exercise Program and Wearable Postural Biofeedback in people with Axial Spondyloarthritis (AxSpA) and Ankylosing Spondylitis (AS), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melike N Can, PT (+905449051387, melikenrcan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease Activity Assessed by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07776652, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.