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临床试验/NCT05116722
NCT05116722Enrolling By Invitation不适用

Shoulder Pacemaker for the Treatment of Scapular Dyskinesia

University of Utah2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
2
主要终点
Visual Analog Scale (VAS) pain

研究概览

简要总结

The investigators purpose of this study is to determine patients-reported outcomes (VAS pain scores) in patients with Scapular Dyskinesis or Posterior Shoulder Instability who undergo rehabilitation with a shoulder pacemaker.

详细描述

The scapula plays a key role in nearly every aspect of normal shoulder function. Shoulder dyskinesia or scapula winging effects patients as a result of nerve injury or muscle detachment or abnormal muscle recruitment. Patients with abnormal muscle recruitment often are helped the most by therapy but restoring normal firing can be difficult. Abnormal muscle recruitment is due to pain or weakness or instability of the glenohumeral joint and the muscles around the scapula attempt to compensate for the lack of normal firing patterns. In many patients, physical therapy and surgery have proven to be unsuccessful treatment options.

The Shoulder Pacemaker is a device that specifically aims at resolving functional issues that surgery and physical therapy are unable. It's a wearable electro stimulator created for patients suffering from unbalanced muscle activation in the shoulder, such as Scapular Dyskinesis. The Shoulder Pacemaker delivers "smart stimulation" through a dynamic interaction between the patient and the device. The motion technology recognizes muscle movement and automatically sets the appropriate stimulation intensity according to the movement. This process helps to restore normal muscle activation patterns and equilibrium. The pacemaker will hopefully assist in restoring normal muscle recruitment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scapular Dyskinesis
  • Posterior Shoulder Instability

排除标准

  • Rotator Cuff Tearing
  • Shoulder Arthritis
  • Patients with implantable electrical/electronic devices
  • If participants are using wearable electrical medical devices, such as glucose sensors or infusion pumps, these devices will be turned off or the participants will be excluded from the study.

研究组 & 干预措施

Shoulder Pacemaker Treatment

Experimental

The patients will be treated using the pacemaker for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy.

干预措施: Shoulder Pacemaker (Device)

结局指标

主要结局

Visual Analog Scale (VAS) pain

时间窗: 12-months

VAS pain score (0 no pain - 10 severe pain)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Tashjian

Principle Investigator

University of Utah

研究点 (2)

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