| CTRI Number |
CTRI/2025/07/091674 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Reliability Study |
| Study Design |
Other |
|
Public Title of Study
|
How Accurate is the GaitON Motion Tracking System for posture analysis. |
|
Scientific Title of Study
|
Evaluating the Reliability of the GaitON Motion Analysis System for Postural Assessment in Healthy and Chronic Low Back Pain (CLBP) Collegiate Population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Shahiduz Zafar |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
B-312, Third Floor, B Block, Galgotias University, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9811701345 |
| Fax |
|
| Email |
shahiduz.zafar@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumbul Ansari |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
B-312, Third Floor, B Block, Galgotias University, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9315918826 |
| Fax |
|
| Email |
sumbulansari@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mahima Trivedi |
| Designation |
MPT Student |
| Affiliation |
Galgotias University |
| Address |
B-312, Third Floor, B Block, Galgotias University, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7307245858 |
| Fax |
|
| Email |
mahimatrivedi1807@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| Type of Sponsor |
Other [Private University] |
|
|
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 |
| Prof Dr Shahiduz Zafar |
Galgotias University |
Biomechanics Lab (Room number 302), Block D, Glagotias University, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
9811701345
shahiduz.zafar@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
The study will recruit collegiate students aged 18 to 25 across both genders. Participants selected for the chronic low back pain (CLBP) group will need to meet additional criteria. They will be required to have a confirmed diagnosis of CLBP - defined as lower back pain persisting for three months or more – verified by a physical therapist. They will also need to report mild to moderate pain levels on the Numeric Pain Rating Scale (NPRS) and score between 20% to 40% on the Oswestry Disability Index (ODI). Based on these criteria, 12 healthy collegiate with CLBP will be enrolled. A group of 12 healthy collegiate, matched for age and gender and free from any health conditions, will also be included. |
|
| ExclusionCriteria |
| Details |
Any other orthopedic or medical condition aside from CLBP and any symptoms suggestive of inflammation, such as fever, infection, or swelling. Used nonsteroidal anti-inflammatory drugs or received steroid injection in the past year, or have undergone and spinal surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Posture |
Baseline and re-test after 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
Target Sample Size
Modification(s)
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/08/2025 |
| 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="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
|
Although GaitON® offers a promising tool for posture and gait evaluation, limited evidence exists on its reliability across population, especially in those suffering from CLBP. Establishing its intra-rater and inter-rater reliability in both healthy and symptomatic individuals will help clinicians and researchers adopt this technology confidently for postural assessment and treatment planning. |