| CTRI Number |
CTRI/2024/09/074122 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| 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
|
Upper Back Muscle Biofeedback Device for Shoulder Problems. |
|
Scientific Title of Study
|
Design, Development and Testing of Scapular Muscle Re-Educator Device for Shoulder Rehabilitation: A Multiphasic Exploratory 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 |
Darshi Doshi |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK University. |
| Address |
Research Department, Room no. 207, School of Physiotherapy, RK University Kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
8000399880 |
| Fax |
|
| Email |
ddoshi262@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Krupa Harikrishna Tank |
| Designation |
Assistant Professor, School of Physiotherapy, RK University |
| Affiliation |
School of Physiotherapy, RK University. |
| Address |
Research Department, Room no. 207, School of Physiotherapy, RK University Kasturbadham Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
9998810063 |
| Fax |
|
| Email |
krupa.tank@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Darshi Doshi |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK University. |
| Address |
Research Department, Room no. 207, School of Physiotherapy, RK University Kasturbadham Rajkot-Bhavnagar Highway, Rajkot,
Gujarat, India.
Rajkot
GUJARAT
360020
India
Rajkot
GUJARAT
360020
India |
| Phone |
8000399880 |
| Fax |
|
| Email |
ddoshi262@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar
Highway, Rajkot, Gujarat |
|
|
Primary Sponsor
|
| Name |
Darshi Doshi |
| Address |
School of Physiotherapy , RK University, Kasturbadham ,
Rajkot-Bhavnagar Highway, Rajkot-360020,Gujarat,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 |
| Darshi Doshi |
RK Physiotherapy Rehabilitation and Research Center |
Physiotherapy
Department, Room no.
1, Opp.Meghani Rang Bhuvan,Bhaktinagar
Circle Rajkot, Gujarat,
India
Rajkot
GUJARAT
Rajkot
GUJARAT |
8000399880
ddoshi262@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, School of Physiotherapy, R K University. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Scapular Muscle Re-Educator Device |
This device will help in providing biofeedback to the patients, while they are performing exercises. It will be given 5 days per week for 3 weeks. |
| Comparator Agent |
Traditional Method (Physiotherapist Observation) |
This method includes correction/biofeedback of the exercise by the physiotherapist.
It will be given 5 days per week for 3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults (above 18 years).
2. Shoulder complex pathologies like tendon inflammation (bursitis or tendinitis), tendon tear, instability, arthritis, fractures, etc.
|
|
| ExclusionCriteria |
| Details |
1. Upper back pain patients.
2. Deformity of scapula (Sprengel) or spine.
3. Scapula fractures.
4. Not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MMT of Scapular Muscle |
Baseline and After 1 week.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quest 2.0 |
After Completion of Intervention. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Title: Design, Development and Testing of Scapular muscle reeducator device for shoulder rehabilitation : A multiphasic exploratory study Investigator: Darshi Doshi PT, Krupa Tank PhD scholar, MPT Background: | Shoulder pain is one of the most common presenting complaints in the community and is a highly prevalent presentation in trauma and orthopedic clinics. According to population surveys, shoulder pain affects 18-26% of adults at any point in time making it one of the most common regional pain syndromes. It’s lifetime prevalence is 6.7-66.7%.The scapula, plays a crucial role in normal shoulder function. When scapular movement is disrupted by abnormal muscle firing patterns, weakness, or injury, the shoulder complex becomes less efficient and more prone to injuries like impingement syndrome, SLAP lesions, and multidirectional instability. In response to this, scapular muscle re-educator is a device that can be useful for shoulder rehabilitation and retrain scapular muscles. This device offers a potential solution for enhancing rehabilitation by providing biofeedback and promoting proper scapular movement patterns. Method: Phase 1 - Designing of device Phase 2 - Development of device Phase 3 - Testing of device | |