| CTRI Number |
CTRI/2025/07/091122 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Joint Position Sense and It’s Association with Deviations in Gait Parameters Among Children of Different Weight Categories |
|
Scientific Title of Study
|
Relationship Between Proprioception and Deviations of Gait Parameters in Normal, Overweight and Obese Children- A Cross-Sectional 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 Naveena A J |
| Designation |
Postgraduate Student |
| Affiliation |
Nitte Institute Of Physiotherapy |
| Address |
Department of Physiotherapy, Room no.60, Second base division ,
Nitte Institute of Physiotherapy, NITTE Deemed to be University,
Deralakatte, Mangaluru.
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9207122462 |
| Fax |
|
| Email |
naveenaaj2000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rakesh Krishna Kovela |
| Designation |
Associate Professor |
| Affiliation |
Nitte Institute Of Physiotherapy |
| Address |
Department of Physiotherapy, Room no.60, Second base division ,
Nitte Institute of Physiotherapy, NITTE Deemed to be University,
Deralakatte, Mangaluru.
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7204346274 |
| Fax |
|
| Email |
rakesh.krishna@nitte.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Rakesh Krishna Kovela |
| Designation |
Associate Professor |
| Affiliation |
Nitte Institute Of Physiotherapy |
| Address |
Department of Physiotherapy, Room no.60, Second base division ,
Nitte Institute of Physiotherapy, NITTE Deemed to be University,
Deralakatte, Mangaluru.
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7204346274 |
| Fax |
|
| Email |
rakesh.krishna@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Institute Of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Nitte Institute Of Physiotherapy (NITTE Deemed to be University) |
| Address |
Nitte Institute of Physiotherapy (Deemed to be University), Medical Science complex, Post Nithyananda Nagar, Deralakatte - Mangaluru- 575018, Karnataka, India. |
| Type of Sponsor |
Private medical college |
|
|
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 Naveena A J |
Nitte Institute Of Physiotherapy |
Department of Physiotherapy, Room no.60, Second base division ,
Nitte Institute of Physiotherapy, NITTE Deemed to be University,
Deralakatte, Mangaluru. Dakshina Kannada KARNATAKA |
9207122462
naveenaaj2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Nitte Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Deviations in gait parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of age group 7-12 years.
2.Both boys and girls are included.
3.Children whose BMI falls in normal weight, overweight and obese category and are assessed on the basis of WHO growth standards. |
|
| ExclusionCriteria |
| Details |
1.Children who underwent any recent surgery to the spine or the lower limb.
2.Children who have any fixed spinal deformity.
3.Children who have any established medical diagnosis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knee Proprioception |
Once at the time of Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gait Parameters including Stride length, Walking velocity and Cadence |
Once at the time of Assessment |
|
|
Target Sample Size
|
Total Sample Size="114" Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
02/01/2026 |
| 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 Applicable |
| 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
|
Proprioception plays a key role in maintaining postural control and coordinating efficient gait patterns. In children, especially those with increased BMI, deficits in proprioception is noted which could potentially contribute to gait deviations such as altered stride length, cadence, and velocity. Childhood obesity is rising globally, yet the relationship between proprioception and gait abnormalities in different BMI categories remains underexplored. This study aims to see if there is any association between proprioception and deviations in gait parameters among normal weight, overweight, and obese children aged 7 to 12 years. Children will be assessed for proprioception using a knee joint repositioning test and gait parameters including stride length, cadence, and walking velocity using the paper and ink method. The findings may help distinguish whether gait alterations are primarily a result of proprioceptive dysfunction or just high body mass itself. The results could support early identification and targeted physiotherapy strategies to improve motor function in children across weight categories. |