| CTRI Number |
CTRI/2024/09/073601 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Designing and Creating a New Medical Device: A Simple Solution for Shoulder Problems |
|
Scientific Title of Study
|
Designing and Developing a Novel Medical Device Prototype, One Stop Solution for Shoulder Dysfunction – An Exploratory Multiphasic Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Namrata Sojitra |
| Designation |
Assistant Professor |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
9427110124 |
| Fax |
|
| Email |
namrata.sojitra@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Sojitra |
| Designation |
Assistant Professor |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
9427110124 |
| Fax |
|
| Email |
namrata.sojitra@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Sojitra |
| Designation |
Assistant Professor |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
9427110124 |
| Fax |
|
| Email |
namrata.sojitra@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, RK University |
|
|
Primary Sponsor
|
| Name |
Dr. Namrata Sojitra |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Namrata Sojitra |
School of Physiotherapy, RK University |
Research Department, Room no. 207, School of Physiortherapy, RK
University kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT |
9427110124
namrata.sojitra@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, School of Physiotherapy, RK University, Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous passive movements, Resisted Exercises, Active assisted exercises |
This newly developed device offers one stop solution for shoulder rehabilitation, designed to deliver active-assisted exercises, continuous passive movements, and resisted exercises. To evaluate the devices effectiveness, 40 patients with various shoulder conditions will be selected. Each patient will undergo treatment using the device, which includes continuous passive movements, as well as active-assisted and resisted exercises. The active-assisted and resisted exercises will consist of 10 repetitions targeting shoulder flexion/extension, abduction/adduction, and internal/external rotation. Continuous passive movement therapy will be administered for 15 minutes per session. Training will be conducted 5 days a week for a total of 3 weeks. |
| Comparator Agent |
N/A |
There is no comparator agent because this trial aims to check effectiveness of the device by taking pre and post treatment data. It dose not aim to compare this device with any other treatment regimes |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with shoulder dysfunction
Patients with restricted shoulder flexion and abduction above 90°
|
|
| ExclusionCriteria |
| Details |
Hyper mobile shoulder joint
Reflex sympathetic Dystrophy
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Goniometry for Range of Motion, Manual muscle testing for muscle strength and NPRS for pain will be primary outcome measures |
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 Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |