| CTRI Number |
CTRI/2025/07/091327 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Measuring How Quickly Children Of age 6-14 years Go Up And Down The Stairs |
|
Scientific Title of Study
|
Establishing The Reference Value For Timed Up and Down Stairs Test In Children Aged 6-14 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 |
Ahana Sah |
| Designation |
PG student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room number B 34,Ground Floor, Department of Physiotherapy
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar(Deemed To Be University) Mullana Ambala Haryana pincode-133207
Ambala
HARYANA
133207
India |
| Phone |
7782816897 |
| Fax |
|
| Email |
ahanasah77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar PT |
| Designation |
Assitant Profeesor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room number B 34,Ground Floor, Department of Physiotherapy
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar(Deemed To Be University) Mullana Ambala Haryana pincode-133207
Ambala
HARYANA
133207
India |
| Phone |
8572098743 |
| Fax |
|
| Email |
narwalamit336@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Kumar PT |
| Designation |
Assitant Profeesor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room number B 34,Ground Floor, Department of Physiotherapy
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar(Deemed To Be University) Mullana Ambala Haryana pincode-133207
Ambala
HARYANA
133207
India |
| Phone |
8572098743 |
| Fax |
|
| Email |
narwalamit336@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ahana Sah PT |
| Address |
Room number B 34 Ground Floor Department of Physiotherapy Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar(Deemed To Be University) Mullana Ambala Haryana pincode 133207 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Ahana Sah |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room number B 34 Ground Floor Department of Physiotherapy Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar(Deemed To Be University) Mullana Ambala Haryana
Ambala
HARYANA |
7782816897
ahanasah77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE MAHARISHI MARKANDESHWAR INSTITUTEOF MEDICAL SCIENCES AND RESEARCH MULLANA, AMBALA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic school going children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
School going children aged 6 to 14 years.
Both male and female.
All the children willing to perform TUDS.
Children able to understand and follow verbal commands. |
|
| ExclusionCriteria |
| Details |
1 Children on any medication
2 Any sensory impairments (Eg: vision and/or hearing loss)
3 Children with any or had acute or chronic diseases, cardiac, respiratory, neurological disorders and had intellectual or learning disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Timed Up and Down Stairs test |
Baseline, 3 times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Height, Weight and Body Mass Index |
Baseline, 3 times |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| 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 Yet Recruiting |
| 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
|
This study aims to establish normative reference values for the Timed Up and Down Stairs TUDS test among healthy Indian children aged 6 to 14 years addressing the current lack of data for this demographic. In a cross-sectional design 400 children from diverse socioeconomic backgrounds will participate, with anthropometric and physiological data heart rate and SpO2 collected before and after the test. Each child will perform three TUDS trials and the fastest time will be analyzed using SPSS software. The findings will provide crucial benchmarks for clinicians to assess and monitor functional mobility and identify potential developmental issues in Indian school-aged children. |