| CTRI Number |
CTRI/2024/05/067529 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Reference value of 360º turn test in children with different body composition |
|
Scientific Title of Study
|
Reference value of 360º turn test in children with different body composition |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suraya Niyaz |
| Designation |
MPT STUDENT |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9596403219 |
| Fax |
|
| Email |
bhatsuraya66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KANU GOYAL |
| Designation |
ASSISTANT PROFFESOR |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of pediatric physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
7015143108 |
| Fax |
|
| Email |
kanu.goyal@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
KANU GOYAL |
| Designation |
ASSISTANT PROFFESOR |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of pediatric physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
7015143108 |
| Fax |
|
| Email |
kanu.goyal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Pediatrics Physiotherapy research lab, Markandeshwar Institute of Physiotherapy, Maharishi Markandeshwar Deemed to be University, Ambala, Haryana, India. 133207 |
|
|
Primary Sponsor
|
| Name |
Suraya Niyaz |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar deemed to be university,
Ambala |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kanu Goyal |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar deemed to be university, Mullana
Ambala |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suraya Niyaz |
Maharishi Markandeshwar Institute of Physiotherapy And Rehabilitaton |
Department Of Physiotherapy
Room no.203,Block B
Mullana University Campus
Mullana
Ambala
Haryana,133207
India
Ambala
HARYANA |
9596403219
bhatsuraya66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, Maharishi Markandeshwar of Medical Science and Research mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
School Going Children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged between 5 to 15 years
2. Both males and females
3.BMI for 5 to 15 years old children
Normal:5th percentile to less than the 85th percentile
Overweight:85th to less than the 95th percentile.
Obese:Equal to or greater than the 95th percentile
4.Able to follow verbal commands
|
|
| ExclusionCriteria |
| Details |
1. Reluctance to execute the assigned tasks.
2. Non-cooperative children.
3. Presence of a neurodevelopmental or neuromotor disorder.
4. Significant visual impairment.
5. Afflicted with any health condition that might affect balance.
6. Taking medications known to influence balance.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 360º turn test |
Three time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
27/05/2024 |
| 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="1"
Months="6"
Days="0" |
|
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
|
The concept of
balance refers to the body’s capacity to maintain its center of gravity
directly above its supporting base. Balance is a
fundamental requirement for regular functioning across all age groups. Balancing skills start developing from when a baby is born. Most babies can stand and
then walk on their own between 10 to 18 months. As kids grow a little older,
like in preschool, they keep getting better at moving around and using their
bodies. They get good at balancing, staying steady, and controlling their posture.
Around the age of 6 to 7 years, children begin to develop adult-like balance.For a child to do
well, they need to be able to do age-appropriate activities on their own and
without getting hurt. Research has demonstrated that a child’s body composition
can affect their development and skills.Thia study is intended to find out the reference of 360-degree turn tes |