| CTRI Number |
CTRI/2025/11/097015 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
BHIMS: A Step Toward Smarter, Non-Invasive Scapular Assessment |
|
Scientific Title of Study
|
Design and Development of BHIMS a Medical non invasive device to measure translatory and rotatory movement of the scapula - A 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 Bindu Sarfare PT |
| Designation |
Professor and PhD scholar |
| Affiliation |
School of Physiotherapy RK university |
| Address |
Kasturbadham Rajkot Bhavnagar highway Rajkot Gujarat
NIL
Rajkot
GUJARAT
360020
India |
| Phone |
09850038842 |
| Fax |
|
| Email |
drbindu.sarfare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Sharma PT |
| Designation |
Dean School of Physiotherapy |
| Affiliation |
School of Physiotherapy RK university |
| Address |
Kasturbadham Rajkot Bahvnagar highway Rajkot Gujarat
NIL
Rajkot
GUJARAT
360020
India |
| Phone |
9811281520 |
| Fax |
|
| Email |
amit.sharma@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Sharma PT |
| Designation |
Dean School of Physiotherapy |
| Affiliation |
School of Physiotherapy RK university |
| Address |
Kasturbadham Rajkot Bahvnagar highway Rajkot Gujarat
NIL
Rajkot
GUJARAT
360020
India |
| Phone |
9811281520 |
| Fax |
|
| Email |
amit.sharma@rku.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Bindu Sarfare |
RK University |
School of Physiotherapy .Kasturbadham ,Rajkot-Bhavnagar Highway Gujarat , India
Rajkot
GUJARAT |
9850038842
drbindu.sarfare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School of Physiotherapy, RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.The ability to lift bilateral upper extremity upto 180 degree in frontal and saggital plane
2. No self reported medical conditions relating to the upper extremity or spine
3.Age 18-25 years both genders
4. Willingness to attend 2 testing sessions separated by atleast 24 hours |
|
| ExclusionCriteria |
| Details |
1.Any Congenital defect of the scapula
2.Any history of shoulder girdle pain or pathology
3.Cervical pain or cervical radiculopathy pain with radiating to shoulder
4.Thoracic outlet syndrome
5.Surgery or trauma to thoracic spine , rib cage , shoulder girdle or cervical spine
6.Surgery or trauma to thoracic spine , rib cage , shoulder girdle or cervical spine
7.Leg length discrepancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The newly developed device can measure translatory movements in mm and rotatory movements in angle . to check the validity on healthy individuals . the translatory movements and rotatory movements was compared with gold standard devices. Intra rater reliability was checked on the same individuals with a gap og 24 hours and inter rater reliability was checked with 2 qualified physiotherapists |
validity checking 15 days and reliability 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the bilateral translatory and rotatory movement of scapula among badminton players |
1 week for assessment |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
17/11/2025 |
| 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="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
|
The current research seeks to design and develop BHIMS, an innovative non-invasive medical device for the precise measurement of scapular translatory and rotatory movements. The multiphasic study encompasses the conceptualization, hardware-software integration, calibration, and validation of the device, succeeded by clinical testing on healthy individuals and targeted sports populations. BHIMS uses sensor-based technology to accurately and consistently record the parameters of scapular motion. The goal of the project is to show that the device is reliable, valid, and useful for physiotherapists and researchers who want to measure scapular kinematics in both static and dynamic situations. |