| CTRI Number |
CTRI/2025/08/092431 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Testing the Accuracy of the Angulus App to Measure Joint Movements in Orthopedic Patients |
|
Scientific Title of Study
|
Validity and Reliability of an Angulus Smartphone Application for Measuring Different Joint Motions in Orthotics Cases. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swagatika Mishra |
| Designation |
PROFESSOR |
| Affiliation |
MGM INSTITUTE OF HEALTH SCIENCES |
| Address |
Department of Prosthetics and Orthotics, MGM INSTITUTE OF HEALTH SCIENCES SEC-01, KAMOTHE , NAVI MUMBAI
Department of Prosthetics and Orthotics, MGM INSTITUTE OF HEALTH SCIENCES SEC-01, KAMOTHE , NAVI MUMBAI
Raigarh
MAHARASHTRA
410209
India |
| Phone |
08691880410 |
| Fax |
|
| Email |
drswagatikamishra@mgmudpo.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swagatika Mishra |
| Designation |
PROFESSOR |
| Affiliation |
MGM INSTITUTE OF HEALTH SCIENCES |
| Address |
Department of Prosthetics and Orthotics, MGM INSTITUTE OF HEALTH SCIENCES SEC-01, KAMOTHE , NAVI MUMBAI
Department of Prosthetics and Orthotics, MGM INSTITUTE OF HEALTH SCIENCES SEC-01, KAMOTHE , NAVI MUMBAI
Raigarh
MAHARASHTRA
410209
India |
| Phone |
08691880410 |
| Fax |
|
| Email |
drswagatikamishra@mgmudpo.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swagatika Mishra |
| Designation |
PROFESSOR |
| Affiliation |
MGM INSTITUTE OF HEALTH SCIENCES |
| Address |
Department of Prosthetics and Orthotics, MGM INSTITUTE OF HEALTH SCIENCES SEC-01, KAMOTHE , NAVI MUMBAI
Department of Prosthetics and Orthotics, MGM INSTITUTE OF HEALTH SCIENCES SEC-01, KAMOTHE , NAVI MUMBAI
Raigarh
MAHARASHTRA
410209
India |
| Phone |
08691880410 |
| Fax |
|
| Email |
drswagatikamishra@mgmudpo.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Health Sciences, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Swagatika Mishra |
| Address |
MGM INSTITUTE OF HEALTH SCIENCES SEC-01, KAMOTHE , NAVI MUMBAI |
| 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 Swagatika Mishra |
MGM Institute of Health Sciences |
Department of Prosthetics & Orthotics, MGM INSTITUTE OF HEALTH SCIENCES SEC-01, KAMOTHE , NAVI MUMBAI
410209
Raigarh
MAHARASHTRA |
08691880410
drswagatikamishra@mgmudpo.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Research on Human Subjects of MGM Institute of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M411||Juvenile and adolescent idiopathicscoliosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Fifty participants, ranging from 18 to 60 Years, will be chosen from an orthotic rehabilitation facility. Participants will witness musculoskeletal conditions that bear orthotic support |
|
| ExclusionCriteria |
| Details |
Individuals with severe pain, recent surgical procedures, or neurological problems affecting ROM would be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Screening of Adolescent girls for flexible Scoliosis, so that conservative treatment can suffice |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Angulus can be further extended for Telerehabilitation for rural areas |
one year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
13/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is pivotal for validating the Angulus smartphone operation as a clinically feasible tool for common ROM assessment in orthotic care. Accurate ROM dimension is foundational in formulating effective recuperation protocols, individualized treatment, and achieving optimal functional issues.
Although goniometry is the standard system, it demands clinical training and structure, making it less accessible for individuals in pastoral or underserved areas. By attesting to the trustworthiness of the Angulus app, this exploration promotes the advancement of digital health results that complement traditional clinical practices.
Smartphone-grounded ROM assessment may reduce reliance on in-person visits, lower healthcare costs, and enhance patient engagement, especially within remote and home-based recuperation programs.
|