| CTRI Number |
CTRI/2026/03/106242 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on foot arch shape and walking balance in children aged 7 to 9 years |
|
Scientific Title of Study
|
Association Between Foot Arches And Dynamic Balance In Typically Developing Children Aged 7-9 Years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Noor Mohamed |
| Designation |
Post Graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Door no. 1.5, First Floor, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu - 600116
Chennai
TAMIL NADU
628204
India |
| Phone |
06383648184 |
| Fax |
|
| Email |
noor100.js@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Rajeswari |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Door no. 4.1, Fourth Floor, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841417473 |
| Fax |
|
| Email |
rajeswarim@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Rajeswari |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Door no. 4.1, Fourth Floor, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841417473 |
| Fax |
|
| Email |
rajeswarim@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1 Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu - 600116 |
| 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 |
| Noor Mohamed |
St. Annal Matriculation School |
St. Annal Matriculation School, Das Main Rd, Parasnath Nagar, Iyyappanthangal, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU |
6383648184
noor100.js@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Students Projects,Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research [Deemed to be University], Porur, Chennai-600116, Tamil Nadu, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pes planus and Pes Cavus |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 7-9 yrs at the time of enrollment.
2.Both genders
3.Ability to follow simple verbal commands or demonstrated instructions |
|
| ExclusionCriteria |
| Details |
1.Children who underwent any recent surgeries in lower limb
2.Any musculoskeletal injuries in lower limb
3.Any Neurological or developmental disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Toe Grip Strength
Staheli Index
Y-Balance Test |
At Baseline (Single assessment session) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
25/03/2026 |
| 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="3"
Days="15" |
|
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
|
This observational study aims to investigate the association between foot arch morphology, toe grip strength (TGS), and dynamic balance in a healthy pediatric population aged 7 to 9 years. As the human foot matures, the development of the medial longitudinal arch (MLA) and the strengthening of intrinsic foot muscles (IFM) are critical for shock absorption, force distribution, and postural stability. The study will be conducted at a matriculation school in Chennai with a calculated sample size of 85 participants. To move beyond subjective visual observations, the research utilizes three objective, quantifiable assessment tools: Staheli Arch Index (SAI) evaluates longitudinal arch height using static weight-bearing footprints. Novel IFM Dynamometer provides reliable measurements of toe grip strength, serving as a proxy for intrinsic foot muscle activation. Y-Balance Test (YBT) assesses dynamic postural control and functional stability through normalized reach distances in three directions. Establishing these relationships in typically developing children is essential for identifying "red flags" in motor development. Given the rise in sedentary behavior among children, these findings will assist neurophysiotherapists and pediatricians in creating early intervention protocols and prevention programs to promote lifelong musculoskeletal health.
|