跳至主要内容
临床试验/CTRI/2024/09/073601
CTRI/2024/09/073601尚未招募2/3 期

Designing and Developing a Novel Medical Device Prototype, One Stop Solution for Shoulder Dysfunction – An Exploratory Multiphasic Study

Dr. Namrata Sojitra1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Goniometry for Range of Motion, Manual muscle testing for muscle strength and NPRS for pain will be primary outcome measures

研究概览

简要总结

Background: The shoulder is an unique anatomical structure with an extraordinary Range of Motion (ROM) that allows us to interact with our environment.1 The shoulder consists of three bones and four joints. The shoulder girdle consists of the clavicle, scapular, and humeral head. Among the joints of the shoulder, which are the glenohumeral, sternoclavicular, acromioclavicular, and scapulothoracic joints, the glenohumeral joint is the major shoulder joint that involves a complex articulation between the humeral head and the glenoid cavity of the shoulder girdle. The global elevation range of motion (RoM) of the arm is mainly the result of a coordinated motion between the movements of the GH and ST joints, which contribute 30% to 40% of the total movement of the arm

Shoulder pain is the third most common musculoskeletal disorder, with incidence rates up to 2.5% and prevalence figures that range from 6.9% to 26% for point prevalence, which rise up to 66.7% for lifetime prevalence in the general population.

Continuous Passive Motion (CPM) Machine is a device that used for help patients to move the joints. Passive and continuous movements which generated by CPM Machine can help out patient during doing the rehabilitation to restore joint movement

Aim: To Design and develop a novel medical device prototype for shoulder dysfunction

Materials and Methods: it will be multiphase study with interdisciplinary approach to design and develop a novel device for shoulder dysfunction. Study will be carried out in 3 phases.

Phase-1 Design and develop a therapeutic device for shoulder rehabilitation

Pahse-2 To make sure the device is feasible for patients and physiotherapists

Phase-3 Introducing the device to Patients with shoulder dysfunction

研究设计

研究类型
Interventional

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with shoulder dysfunction Patients with restricted shoulder flexion and abduction above 90°.

排除标准

  • Hyper mobile shoulder joint Reflex sympathetic Dystrophy.

结局指标

主要结局

Goniometry for Range of Motion, Manual muscle testing for muscle strength and NPRS for pain will be primary outcome measures

时间窗: All the Outcome measures will be measured prior to the intervention and post measurement data will be taken at the end of 3 weeks

次要结局

  • N/A(N/A)

研究者

发起方
Dr. Namrata Sojitra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Namrata Sojitra

School of Physiotherapy, RK University

研究点 (1)

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