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Clinical Trials/CTRI/2024/09/073601
CTRI/2024/09/073601Not yet recruitingPhase 2/3

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

Dr. Namrata Sojitra1 site in 1 country40 target enrollmentStarted: September 20, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Goniometry for Range of Motion, Manual muscle testing for muscle strength and NPRS for pain will be primary outcome measures

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
40.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

  • Hyper mobile shoulder joint Reflex sympathetic Dystrophy.

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • N/A(N/A)

Investigators

Sponsor
Dr. Namrata Sojitra
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Namrata Sojitra

School of Physiotherapy, RK University

Study Sites (1)

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