Device-Assisted Balance Training for People With Shoulder Impingement
The Effect of Balance Training on Central Sensitization and Clinical Outcomes in Patients With Subacromial Impingement Syndrome: A Single-Blinded Randomized Controlled Trial
This randomized controlled study will examine whether adding device-assisted balance training to conventional physiotherapy improves symptoms related to increased pain sensitivity, shoulder pain, shoulder function, and balance in adults with subacromial impingement syndrome. A total of 78 participants will be randomly assigned to receive either balance training plus conventional physiotherapy or conventional physiotherapy alone for six weeks. Assessments will be performed before and after treatment by an assessor who is unaware of group allocation.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This assessor-blinded, two-arm randomized controlled trial compares device-assisted balance training added to conventional physiotherapy with conventional physiotherapy alone in adults with unilateral subacromial impingement syndrome. The treatment period is six weeks. The primary outcome is the change in Central Sensitization Inventory. Secondary outcomes include shoulder pain and disability, fear of movement, pressure pain thresholds, and static and dynamic balance. Outcomes are assessed at baseline and immediately after treatment.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nur Begüm Gül, MD
- Numéro de téléphone: +905362096276
- E-mail: nurbegum.gul@gmail.com
Lieux d'étude
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Istanbul, Turquie (Türkiye)
- Recrutement
- Emsey Hospital
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Contact:
- Nur Begüm Gül, MD
- Numéro de téléphone: +905362096276
- E-mail: nurbegum.gul@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age between 18 and 80 years.
- Diagnosis of unilateral subacromial impingement syndrome.
Exclusion Criteria:
- History of trauma or surgery within the past six months.
- Physiotherapy within the past six months.
- Intra-articular injection within the past six months.
- Cognitive impairment.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Balance exercise protocol
Participants receive BOBO device-assisted balance exercises combined with upper-limb movements in addition to conventional physiotherapy for six weeks. Conventional physiotherapy includes shoulder range-of-motion exercises, heat application, and non-invasive electrophysical modalities prescribed by the rehabilitation physician. |
Participants receive balance exercises using a BOBO balance board combined with upper-limb movements, in addition to conventional physiotherapy, for six weeks. Participants receive conventional physiotherapy consisting of shoulder range-of-motion exercises, heat application, and non-invasive electrophysical modalities prescribed by the rehabilitation physician for six weeks. |
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Comparateur actif: Conventional exercise protocol
Participants receive conventional physiotherapy alone for six weeks, including shoulder range-of-motion exercises, heat application, and non-invasive electrophysical modalities prescribed by the rehabilitation physician. |
Participants receive conventional physiotherapy consisting of shoulder range-of-motion exercises, heat application, and non-invasive electrophysical modalities prescribed by the rehabilitation physician for six weeks. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Central Sensitization Inventory (CSI)
Délai: Baseline and immediately after the six-week treatment period.
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The Central Sensitization Inventory Part A is a 25-item questionnaire assessing symptoms associated with central sensitization. The total score ranges from 0 to 100, with higher scores indicating greater symptom severity. Change from baseline to the end of the six-week treatment period will be evaluated. |
Baseline and immediately after the six-week treatment period.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Shoulder Pain and Disability Index (SPADI) Total Score
Délai: Baseline and immediately after the six-week treatment period.
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The SPADI is a 13-item questionnaire assessing shoulder pain and disability. The total score ranges from 0 to 100, with higher scores indicating greater pain and disability. Change from baseline to the end of treatment will be evaluated. |
Baseline and immediately after the six-week treatment period.
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Change in Shoulder Pain
Délai: Baseline and immediately after the six-week treatment period.
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Shoulder pain is assessed using a 10-cm Visual Analog Scale, ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. |
Baseline and immediately after the six-week treatment period.
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Change in Tampa Scale for Kinesiophobia Score
Délai: Baseline and immediately after the six-week treatment period.
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The 17-item Tampa Scale for Kinesiophobia assesses fear of movement and reinjury. Total scores range from 17 to 68, with higher scores indicating greater kinesiophobia. |
Baseline and immediately after the six-week treatment period.
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Change in Pressure Pain Threshold
Délai: Baseline and immediately after the six-week treatment period.
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Pressure pain threshold is assessed using a manual algometer at the deltoid, upper trapezius, supraspinatus, and infraspinatus muscles. Pressure is gradually increased until the participant first reports pain. Three measurements are obtained at each site with 30-second rest intervals. Each measurement site is evaluated separately. Higher thresholds indicate lower pressure pain sensitivity. |
Baseline and immediately after the six-week treatment period.
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Change in Y Balance Test Performance
Délai: Baseline and immediately after the six-week treatment period.
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Dynamic balance is assessed using the lower-quarter Y Balance Test in the anterior, posteromedial, and posterolateral directions. Three trials are performed in each direction. Mean reach distances are normalized to limb length and expressed as percentages. The composite score is calculated as the sum of the three directional mean reach distances divided by three times limb length, multiplied by 100. Higher scores indicate better performance. |
Baseline and immediately after the six-week treatment period.
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Change in BOBO Balance Scores
Délai: Baseline and immediately after the six-week treatment period.
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Static balance is assessed using the BOBO balance board during a 20-second single-leg stance task. Participants maintain an on-screen indicator within a target area. Three trials are performed, and the highest score is recorded. Scores range from 0 to 100%, with higher scores indicating better performance. Dynamic balance is assessed using the BOBO balance board during a 20-second single-leg task. Participants control an on-screen indicator to follow a target moving in a figure-eight pattern. Three trials are performed, and the highest score is recorded. Scores range from 0 to 100%, with higher scores indicating better performance. |
Baseline and immediately after the six-week treatment period.
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Change in Single-Leg Stance Time
Délai: Baseline and immediately after the six-week treatment period.
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Static balance is assessed by measuring the duration of unsupported single-leg stance, up to a maximum of 30 seconds. Longer stance times indicate better balance. |
Baseline and immediately after the six-week treatment period.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Amine Ataç, Istanbul Gedik University
Publications et liens utiles
Publications générales
- Bicer A, Ankarali H. Shoulder pain and disability index: a validation study in Turkish women. Singapore Med J. 2010 Nov;51(11):865-70.
- Duzce Keles E, Birtane M, Ekuklu G, Kilincer C, Caliyurt O, Tastekin N, Is EE, Ketenci A, Neblett R. Validity and reliability of the Turkish version of the central sensitization inventory. Arch Rheumatol. 2021 Oct 18;36(4):518-526. doi: 10.46497/ArchRheumatol.2022.8665. eCollection 2021 Dec.
- Tunca Yılmaz Ö, Yakut Y, Uygur F, Uluğ N. Tampa Kinezyofobi Ölçeği'nin Türkçe versiyonu ve test-tekrar test güvenirliği. Fizyoterapi Rehabilitasyon. 2011;22(1):44-49.
- Bumin G, Tüzün EH, Tonga E. The Shoulder Pain and Disability Index (SPADI): Cross-cultural adaptation, reliability, and validity of the Turkish version. J Back Musculoskelet Rehabil. 2008;21(1):57-62. doi:10.3233/BMR-2008-21108.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- E-10840098-50.04-3813
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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