跳至主要内容
临床试验/NCT06702319
NCT06702319进行中(未招募)不适用

İzmir Democracy University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation

Izmir Democracy University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
69
试验地点
1
主要终点
Quick Disabilities of Arm, Shoulder & Hand

研究概览

简要总结

This study aims to evaluate the effectiveness of externally focused shoulder stabilization exercises on range of motion, pain, handgrip strength, and proprioception in patients with rotator cuff tendinopathy. For the study, 69 patients will be randomly divided into three groups: Home Program Group (HPG), Internal Focused Exercise Group (IFEG), and External Focused Exercise Group (EFEG). The treatment period for all three groups will be 6 weeks. Shoulder range of motion, pain, handgrip strength, joint position sense, and shoulder function (WORC and QuickDASH) of the three groups will be evaluated at baseline and after intervention. IFEG will do the exercises with a physiotherapist twice a week. During the exercise, the patient will be allowed to focus on the body parts while performing the movement. EFEG will do the exercises with a physiotherapist twice a week. The patient will be allowed to focus on a point outside the body, namely the effect of the movement, during the exercise. In the management of HPG patients will be provided with an exercise brochure. At the conclusion of the study, the three groups will be compared and evaluated using appropriate statistical analyses to assess the outcomes and determine any significant differences between them.

详细描述

Rotator Cuff Tendinopathy Treatment Various strategies are used in the treatment of rotator cuff tendinopathy as conservative, mini-invasive, and surgical treatments. Conservative treatment includes rest, non-steroidal anti-inflammatory drugs, steroid injections, and physiotherapy methods (Chaudhury et al. 2010). The primary goal in physiotherapy applications is the restoration of normal shoulder movement patterns. It focuses on eliminating the loss of flexibility, movement, and strength that cause pain and regaining functions (Kibler, 2003). The response of tendon cells to load depends on both frequency and load. Tendon cells seem to be programmed to perceive a certain level of stress. Adequate doses of mechanical loading provide repair in the tendon. On the other hand, inadequate stimulation can prevent or slow down healing (Arnocky et al. 2007, Camargo et al. 2014).

Focus of attention Focus of attention refers to the place where a person pays attention while performing a certain movement. Wulf et al. (1998) conducted the first study on the focus of attention. When a person focuses on body parts while performing a movement, it is called internal focus, and when a person focuses on something outside the body, that is, the effect of the movement, it is called external focus. Studies show that external focus is effective in balance, performance, and motor learning (Park et al., 2015; Wulf et al., 2016). It has been determined that external focus is effective in improving motor learning and function (Castillo-Vejar et al., 2022). It has been observed that performing exercises with an external focus provides a decrease in the degree of perceived exertion (Lohse et al., 2011). In a study, the effects of internal focus, external focus, and the application without focus conditions on balance performance were evaluated. As a result, a positive effect of external focus on balance was found. Internal focus has been reported to cause a loss of performance on balance compared to the control group (Wulf et al., 2003).

This study aims to determine whether there is a difference between home exercise program, internal focus exercise, and external focus exercise in patients with Rotator Cuff Tendinopathy.

Exercise Programs Initially, patients will receive training (30 minutes) to ensure that the exercises are applied correctly and to encourage patient compliance.

Home program group (HPG): In addition to medical treatment, a home exercise program with a brochure will be given to the home exercise group. The exercise program includes; posture exercises, codman exercises, wand exercises, strengthening exercises in all directions of the shoulder, and wall ball rolling exercises. It will be stated that they will do the exercises regularly and follow the given recommendations and come for a check-up at the end of 6 weeks. During this period, individuals will be contacted by phone and interim follow-ups will be made.

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)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a diagnosis of rotator cuff tendinopathy,
  • Having sufficient cooperation to perform the exercises.

排除标准

  • Having a neurological problem,
  • Having a previous fracture in the shoulder region,
  • Having undergone a relevant surgery in the past,
  • Having any chronic illness that could prevent exercise (e.g., chronic heart failure, pacemaker, etc.),
  • Having a systemic condition that could affect proprioception, such as diabetes, rheumatoid arthritis, ankylosing spondylitis, or advanced osteoarthritis,
  • Having received a physiotherapy program targeting the neck and upper extremity within the last 3 months.

结局指标

主要结局

Quick Disabilities of Arm, Shoulder & Hand

时间窗: one day before the intervention and 6 weeks after

The Quick Disabilities of Arm, Shoulder \& Hand Index is used to measure upper extremity physical function. A Turkish validity and reliability study has been conducted. The scale includes 11 headings extracted from the long version. Each question consists of a 5-point scale. The total score is calculated with the formula \[(sum of n responses) /n-1\] ×25, where n= indicates the total number of questions answered. The total score varies between 0 (no disability) and 100 (severe disability). The final score is classified as; 0- 15: 'no problem', 16-40: 'problem but able to work', 40 and above: 'unable to work'.

次要结局

  • Shoulder Joint Range of Motion(one day before the intervention and 6 weeks after)
  • Assessment of Shoulder Pain(one day before the intervention and 6 weeks after)
  • Western Ontario Rotator Cuff (WORC) Index(one day before the intervention and 6 weeks after)
  • Assessment of Hand Grip Strength:(one day before the intervention and 6 weeks after)
  • Assessment of Joint Position Sense:(one day before the intervention and 6 weeks after)

研究者

发起方
Izmir Democracy University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ferruh Taşpınar

Prof. Dr.

Izmir Democracy University

研究点 (1)

Loading locations...

相似试验