Postural Biofeedback and Exercise in Axial Spondyloarthritis

NCT07776652 | Not Yet Recruiting

• 1 other identifier: kHo7h153
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Axial Spondyloarthritis (AxSpA); Ankylosing Spondylitis (AS)

Keywords

Axial Spondyloarthritis; Biofeedback; Postural Biofeedback; Exercise Therapy; Posture; Disease Activity

Outcome Measures

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.

  Baseline to Week 8

Secondary Outcomes (8)

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

  Baseline to Week 8

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

  Baseline to Week 8

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

  Baseline to Week 8

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

  Baseline to Week 8

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

  Baseline to Week 8

Study Arms (2)

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.

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.

Behavioral: Standard Exercise Program; Behavioral: Wearable Postural Biofeedback

Interventions

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.

Control Group; Postural Biofeedback Group

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.

Postural Biofeedback Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Faculty of Health Sciences

Istanbul, Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30242992 BACKGROUND

• Coulter 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.

  PMID: 31848736 BACKGROUND

• Thomassen 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.

  PMID: 40334280 BACKGROUND

MeSH Terms

Conditions

Axial Spondyloarthritis; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Central Study Contacts

Melike N Can, PT

CONTACT

+905449051387; melikenrcan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 20, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)