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临床试验/NCT05184309
NCT05184309已完成不适用

Effects of Serious Games for Shoulder Rehabilitation and Measurement of Approximation Force: Randomized Controlled Trial

Istanbul Medipol University Hospital2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2022年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Shoulder approximation force

研究概览

简要总结

The aim of this study is to examine the effect of Serious-Game Exercise (SGE) platform on pain, range of motion (ROM), joint position sense, shoulder functions, and approximation force in patients with rotator cuff rupture. In addition, another objective is to evaluate the usage of balance board as a measurement tool for measuring the approximation force in the rotator cuff rupture.

详细描述

Purpose: To examine the effect of Serious-Game Exercise (SGE) platform on pain, range of motion (ROM), joint position sense, shoulder functions, and approximation force in patients with rotator cuff rupture. In addition, another objective is to evaluate the usage of balance board as a measurement tool for measuring the approximation force in the rotator cuff rupture.

Method: Twenty patients with rotator cuff rupture will be included in the study. They will be divided into two groups as a serious game group (SGG) and a conventional exercise group (CEG) with a randomization method. The Serious game exercise program developed for shoulder rehabilitation will be applied to the SG group and conventional exercise training will be applied to the CEG. Pain severity, flexion, abduction and external rotation ROM, functionality, joint position sense, and approximation force of all individuals will be evaluated pre and post-treatment. SGG and CEG underwent serious games and conventional therapy twice a week for 6 weeks, respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants are blinded in enrollment and assessment process.

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • being between the ages of 40-60,
  • having pain for more than 4 weeks,
  • not having had any shoulder surgery

排除标准

  • Individuals with cervical-origin neurological findings, uncooperative, different orthopedic problems in the same shoulder,
  • neurological, vascular and cardiac problems that limit function

结局指标

主要结局

Shoulder approximation force

时间窗: 5 minutes

Shoulder approximation force will be evaluated with the Becure Balance System. During this measurement, the individual will be asked to put both hands on the Balance Board and then apply downward force without using body weight. Measurements will be taken in standing and sitting positions (0° and 90°).

Pain assessment- Visual Analogue scale

时间窗: 5 minutes

Pain level is measured with the visual analogue scale (VAS), at rest and activity. The visual analogue scale consists of a 10-cm line. Participants were asked to indicate in the scale their current level of pain where the higher values are more intense pain.

Range of motion

时间窗: 5 minutes

The range of motion of the joint of the individuals participating in the study will be evaluated with Becure Extremity ROM. The patient stands in front of the camera and perform the directed movement. In this study, flexion, abduction and external rotation ranges of motion of the shoulder joint will be measured.

Joint position sense

时间窗: 5 minutes

The joint position sense of the individuals will be evaluated with the Becure Extremity ROM. Subjects will be first asked to raise their shoulder to a certain degree and bring it to the same angle value with eyes closed. The difference between shoulder angles will be calculated by recording the angle value formed with eyes closed and open.

次要结局

  • The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire(5 minutes)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

burak menek

Principal investigator

Istanbul Medipol University Hospital

研究点 (2)

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