| CTRI Number |
CTRI/2025/08/092530 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Reliability Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating a New Motion Analysis Tool for Children with Cerebral Palsy |
|
Scientific Title of Study
|
Evaluating the Reliability of the GaitON® Motion Analysis System: A Study on Gait and Posture Analysis in Children with Cerebral Palsy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushi Sharma |
| Designation |
Post Graduate student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Research lab,3rd floor, Amar Jyoti Institute of Physiotherapy
East
DELHI
110092
India |
| Phone |
9953697494 |
| Fax |
|
| Email |
khushisa0802@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manjusha Dobhal (PT) |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Research lab, 3rd floor, Amar Jyoti Institute of Physiotherapy
East
DELHI
110092
India |
| Phone |
9810631299 |
| Fax |
|
| Email |
manjushadobhal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Khushi Sharma |
| Designation |
Post Graduate student |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Research Lab, 3rd floor, Amar Jyoti Institute of Physiotherapy
East
DELHI
110092
India |
| Phone |
9953697494 |
| Fax |
|
| Email |
khushisa0802@gmail.com |
|
|
Source of Monetary or Material Support
|
| Auptimo Technologies LLP, 892B/8, Near Jahaz Mahal, Mehrauli -110030, Delhi India |
|
|
Primary Sponsor
|
| Name |
Khushi Sharma |
| Address |
Amar Jyoti Institute of Physiotherapy, Vikas Marg, Karkardooma, Delhi, 110092 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Khushi Sharma PT |
Amar Jyoti Institute of Physiotherapy |
Physiotherapy Research lab, 3rd floor
East
DELHI |
9953697494
khushisa0802@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amar Jyoti Institute of Physiotherapy Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with Cerebral Palsy aged 7 to 17 years.
The GMFCS score (Gross Motor Function Classification System) ranged from Level I to III, indicating the ability to walk independently, with or without assistive devices like rollators or crutches.
Capable of understanding and following instructions.
|
|
| ExclusionCriteria |
| Details |
Any visual or perceptual deficits.
Any recent (last 6 months) surgical or Botox procedure.
Any recent (within 2 weeks) muscular injury.
Children with severe cognitive impairments or behavioral conditions preventing cooperation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intraclass Correlation Coefficient (ICC) for test-retest reliability
Standard Error of Measurement (SEM)
Smallest Detectable Difference (SDD)
|
At baseline, then again after 48 hours.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of practical challenges or limitations in using GaitON® for children with CP |
2 time points |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
03/10/2025 |
| 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="0"
Days="7" |
|
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
|
This is an observational reliability study that aims to evaluate how consistent the GaitON 2D Motion Analysis System is in measuring gait and posture in children aged 7 to 17 with cerebral palsy. Each child will take part in two gait and two posture assessments with a 48 hour gap between each. Participants will be recruited through convenience sampling from a pediatric rehab setting. The study uses tools like the GaitON system, video cameras, and posture grids, with markers placed on specific body points. Assessments involve walking on a marked path and standing for posture recording, both analyzed by the software. Results will focus on reliability using intraclass correlation, standard error of measurement, and smallest detectable difference. Data will be coded and analyzed using SPSS software. |