| CTRI Number |
CTRI/2025/03/083390 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Exercises in Poor Shoulder Posture |
|
Scientific Title of Study
|
Comparative Effect of Theraband Exercises, Stretching and Breathing
Exercises in Patients with Rounded Shoulder Posture |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akash singh |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar
Hisar HARYANA 125001 India |
| Phone |
9773565160 |
| Fax |
|
| Email |
akashsingh843462@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shabnam Joshi |
| Designation |
Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar
Hisar HARYANA 125001 India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shabnam Joshi |
| Designation |
Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar
HARYANA 125001 India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akash Singh MPT Student Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana India 125001 |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Guru Jambheshwar University of
Science and Technology Hisar Haryana
India
125001 |
| Type of Sponsor |
Research institution |
|
|
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 Shabnam Joshi |
Guru Jambheshwar University of Science and Technology |
Room No 05 Department of Physiotherapy OPD GJUS&T Hisar HARYANA 125001 Hisar HARYANA |
9729922466
shabnamjoshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUS&T |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Theraband Exercises and Stretching Exercises |
Patients in this group will perform Theraband Exercises and Stretching Exercises for three sessions per week for six weeks |
| Intervention |
Theraband Exercises, Stretching Exercises and Breathing Exercises |
Patients in this group will perform Theraband Exercises, Stretching Exercises and Breathing Exercises for three sessions per week for six weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20 to 50 years
Both gender, males and females will be
included in the study
The participants who have distance equal or
more than 2.5cm between posterior aspect of
the acromion process and table
|
|
| ExclusionCriteria |
| Details |
Age less than 20 or more than 50 years
Acute trauma /surgery
Intake of psychotherapeutic drugs
Neurological abnormalities
shoulder subluxation / dislocation
Uncooperative subject |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rigid plastic transparent right-angle triangle
Flexibility
DASS-21 |
The outcome will be assessed for 2 times which is at the baseline and after the 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion |
The outcome will be assessed for 2 times which is at the baseline & after the 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/04/2025 |
| 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="1" Days="12" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is a randomized controlled trial with a duration of 6 weeks and involving 48 patients that will be divided into two groups based on the lottery method. Its intervention involves theraband exercises, stretching and breathing exercises in one group and theraband and stretching exercises in second group. The patients will be informed about the study and written informed consent will be taken. First, each patient’s demographic information including age, height and weight will be gathered as a baseline data. Pre- Intervention measurements of outcome variables including rigid plastic transparent right-angle triangle, flexibility, Range of motion, DASS-21 will be taken. Intervention will be given for 6 weeks and then post-intervention data of all the outcome variables will be taken. |