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Postural Biofeedback and Exercise in Axial Spondyloarthritis

19 agosto 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

38

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Turchia (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turchia (Türkiye), 34500
        • Istanbul University-Cerrahpasa, Faculty of Health Sciences
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Comportamentale: 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.
Sperimentale: 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.
Comportamentale: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Disease Activity Assessed by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Axial Pain Intensity Assessed by the Numeric Rating Scale (NRS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Istanbul University - Cerrahpasa

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

30 maggio 2027

Completamento dello studio (Stimato)

30 giugno 2027

Date di iscrizione allo studio

Primo inviato

18 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 agosto 2026

Primo Inserito (Effettivo)

20 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • kHo7h153

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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