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Device-Assisted Balance Training for People With Shoulder Impingement

2026年10月31日 更新者:Amine Ataç、Istanbul Gedik University

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

78

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Central Sensitization Inventory (CSI)
大体时间:Baseline and immediately after the six-week treatment period.

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.

次要结果测量

结果测量
措施说明
大体时间
Change in Shoulder Pain and Disability Index (SPADI) Total Score
大体时间: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.
Change in Shoulder Pain
大体时间:Baseline and immediately after the six-week treatment period.

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.
Change in Tampa Scale for Kinesiophobia Score
大体时间:Baseline and immediately after the six-week treatment period.

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.
Change in Pressure Pain Threshold
大体时间:Baseline and immediately after the six-week treatment period.

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.
Change in Y Balance Test Performance
大体时间:Baseline and immediately after the six-week treatment period.

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.
Change in BOBO Balance Scores
大体时间:Baseline and immediately after the six-week treatment period.

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.
Change in Single-Leg Stance Time
大体时间:Baseline and immediately after the six-week treatment period.

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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Amine Ataç、Istanbul Gedik University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月24日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2027年3月1日

研究注册日期

首次提交

2026年10月31日

首先提交符合 QC 标准的

2026年10月31日

首次发布 (实际的)

2026年11月4日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年10月31日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • E-10840098-50.04-3813

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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