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Postural Biofeedback and Exercise in Axial Spondyloarthritis

19. august 2026 opdateret af: Melike Nur CAN, Istanbul University - Cerrahpasa

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?

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

38

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkiet (Türkiye), 34500
        • Istanbul University-Cerrahpasa, Faculty of Health Sciences
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control Group
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.
Adfærdsmæssigt: Standard Exercise Program
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.
Eksperimentel: Postural Biofeedback Group
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.
Adfærdsmæssigt: Standard Exercise Program
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.
Adfærdsmæssigt: Wearable Postural Biofeedback
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Disease Activity Assessed by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Tidsramme: 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.
Baseline to Week 8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Axial Pain Intensity Assessed by the Numeric Rating Scale (NRS)
Tidsramme: 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).
Baseline to Week 8
Change in Functional Status Assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI)
Tidsramme: 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.
Baseline to Week 8
Change in Spinal Mobility Assessed by the Bath Ankylosing Spondylitis Metrology Index (BASMI)
Tidsramme: 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.
Baseline to Week 8
Change in Health-Related Quality of Life Assessed by the Ankylosing Spondylitis Quality of Life Scale (ASQoL)
Tidsramme: 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.
Baseline to Week 8
Change in Postural Alignment Assessed by the New York Posture Assessment Method
Tidsramme: 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.
Baseline to Week 8
Change in Functional Exercise Capacity Assessed by the Two-Minute Walk Test
Tidsramme: 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.
Baseline to Week 8
Global Perceived Change Assessed by the Global Rating of Change Scale (GROC)
Tidsramme: 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).
Week 8
Perceived Usability of the Wearable Postural Biofeedback Device Assessed by the System Usability Scale (SUS)
Tidsramme: 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.
Week 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul University - Cerrahpasa

Publikationer og nyttige links

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Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

30. maj 2027

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

18. august 2026

Først indsendt, der opfyldte QC-kriterier

18. august 2026

Først opslået (Faktiske)

20. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • kHo7h153

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