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临床试验/NCT06201325
NCT06201325已完成不适用

Comparison of the Effectiveness of Virtual Reality Based Exercises and Conventional Physical Therapy in the Treatment of Adhesive Capsulitis

Kirsehir Ahi Evran Universitesi2 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2024年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Visual analog scale

研究概览

简要总结

The aim of this study is to evaluate the effectiveness of virtual reality based exercises and conventional physical therapy on shoulder pain, mobility, functional ability and quality of life in adhesive capsulitis and to investigate whether it is superior to the control group.

详细描述

Adhesive capsulitis(AC) is an enigmatic condition characterized by painful, progressive and disabling loss of active and passive shoulder joint range of motion in multiple planes. Approximately 2% to 5% of adults between age 40 and 70 develop adhesive capsulitis with a greater occurrence in women and in individuals with thyroid disease or diabetes. AC is an arthrofibrosis involving the formation of excessive adhesions along the glenohumeral joint. It is a disease of unknown aetiology and is classified as primary and secondary. Primary adhesive capsulitis includes cases of idiopathic origin resulting from chronic inflammation with fibroblast proliferation. Secondary adhesive capsulitis includes central nervous system problem, prolonged immobilisation of the arm, trauma or fracture, infectious diseases, etc. The progression of adhesive capsulitis is characterised by four stages, each stage showing a distinctive clinical presentation:

  1. Painful phase: lasts less than three months and is characterised by shoulder pain at night with preserved glenohumeral motion.
  2. Freezing phase: lasts three to nine months and is characterised by severe pain and stiffness in the glenohumeral joint.
  3. Frozen shoulder process: lasts nine to fourteen months and is characterised by loss of movement and pain in all directions at the end.
  4. Thawing phase: lasts fifteen to twenty-four months and is characterised by persistent stiffness, minimal pain, delayed recovery of shoulder movement.

Interventions for this pathology usually include physical therapy, nonsteroidal anti-inflammatory drug therapy, intra-articular steroid injections, distension arthrography and surgery. Physical therapy is the mainstay of treatment for patients with adhesive capsulitis. Conventional physical therapy consists of electrotherapy modalities such as TENS, Interferential current, Ultrasound, low intensity laser and exercises such as stretching exercises, Codman Exercise, Wand exercises and joint mobilisation and is used to control pain, increase flexibility and improve range of motion.

It is known that it takes a long time to achieve pain relief and a good improvement in ROM in adhesive capsulitis. This situation affects the quality of life of patients and creates a need for easily accessible treatment options that provide faster recovery.

One of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. As noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. Virtual reality (VR) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. As a result, virtual reality (VR) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Investigator and outcomes assesor will be different persons

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

  • Aged between 18-65
  • Clinical diagnosis of adhesive capsulitis
  • Patients with loss of range of motion in a capsular pattern (external rotation >abduction > internal rotation)
  • Participant signed informed consent

排除标准

  • Surgery on the upper extremity or trunk
  • Upper extremity injury in the last 6 months
  • Injections in the shoulder area in the last 6 months
  • Systemic or local infection of shoulder
  • Uncontrolled hypertension
  • Inability to cooperate VR
  • Patient with malignancy
  • Neurological disease

研究组 & 干预措施

Conventional group

Active Comparator

Individuals in the second group, who will be included in the traditional exercise group, will be included in the stretching and strengthening exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. The exercises will be performed by a physiotherapist working in the clinic and blind to the study.

干预措施: conventional physical therapy (Other)

VR group

Active Comparator

VR-based exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. These individuals will use the Microsoft Kinect for Azure VR system in the virtual environment. They will play the registered games. These games will include purpose-oriented activities such as lying on the shelf and using bilaterally, which are intended to use the upper extremities of individuals with AC in daily life.

干预措施: virtual reality based exercises (Other)

VR group

Active Comparator

VR-based exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. These individuals will use the Microsoft Kinect for Azure VR system in the virtual environment. They will play the registered games. These games will include purpose-oriented activities such as lying on the shelf and using bilaterally, which are intended to use the upper extremities of individuals with AC in daily life.

干预措施: home exercises program (Other)

Conventional group

Active Comparator

Individuals in the second group, who will be included in the traditional exercise group, will be included in the stretching and strengthening exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. The exercises will be performed by a physiotherapist working in the clinic and blind to the study.

干预措施: home exercises program (Other)

Control group

Other

In the third group, who will be included in the home exercise group, exercises will be taught to the patient and will be applied for half an hour a day, 5 days a week for a total of 3 weeks.

干预措施: home exercises program (Other)

结局指标

主要结局

Visual analog scale

时间窗: 12th week

The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale

Range of Motion

时间窗: 12th week

Shoulder ROM is measured using a universal protractor(goniometer). Shoulder flection, extension, abduction, internal rotation and external rotation ranges are measured in the supine position.

次要结局

  • SF-36(12th week)
  • Modified Constant-Murley Score(12th week)
  • Shoulder Pain and Disability Index (SPADI)(12th week)

研究者

发起方
Kirsehir Ahi Evran Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Basak Cigdem Karacay

medical doctor, assistant prof

Kirsehir Ahi Evran Universitesi

研究点 (2)

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