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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Nur Begüm Gül, MD
- 電話番号：+905362096276
- メール：nurbegum.gul@gmail.com
研究場所
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Istanbul、トルコ（Türkiye）
- 募集
- Emsey Hospital
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コンタクト：
- Nur Begüm Gül, MD
- 電話番号：+905362096276
- メール：nurbegum.gul@gmail.com
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-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Central Sensitization Inventory (CSI)
時間枠：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.
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Shoulder Pain and Disability Index (SPADI) Total Score
時間枠：Baseline and immediately after the six-week treatment period.
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Amine Ataç、Istanbul Gedik University
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- E-10840098-50.04-3813
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