| CTRI Number |
CTRI/2024/07/070674 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Normative value of TUDS for age between 3-5years. |
|
Scientific Title of Study
|
Normative Data for The Timed Up and Down Stairs (TUDS) Test for Aged 3-5 Years: An Observational 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 |
POONAM MEHER |
| Designation |
PG STUDY |
| Affiliation |
Department of physiotherapy ,Srinivas University ,Pandeshwar, Mangaluru |
| Address |
Department of physiotherapy ground floor
Srinivas University Pandeshwar
Mangaluru
Dakshina kannada
Department of physiotherapy ground floor
Srinivas University
Pandeshwar
Mangaluru
Dakshina kannada
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6370715193 |
| Fax |
- |
| Email |
meherpoonam012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Radhika S Gopal |
| Designation |
Assistant professor |
| Affiliation |
Depertment of physiotherapy ,Srinivas University ,Pandeshwar, Mangaluru |
| Address |
Department of physiotherapy ground floor
Srinivas University
Pandeshwar
Mangaluru
Dakshina kannada
Department of physiotherapy ground floor
Srinivas University
Pandeshwar
Mangaluru
Dakshina kannada
KARNATAKA
575001
India |
| Phone |
9995507379 |
| Fax |
- |
| Email |
radhikaradhu1590@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
POONAM MEHER |
| Designation |
PG Thesis |
| Affiliation |
Department of physiotherapy ,Srinivas University ,Pandeshwar, Mangaluru |
| Address |
Department of physiotherapy ground floor
Srinivas University
Mangalore Karnataka
Department of physiotherapy ground floor
Srinivas University
Mangaluru Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
6370715193 |
| Fax |
- |
| Email |
meherpoonam012@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DRllll Poonam meher |
| Address |
Department of physiotherapy ground floor
Srinivas University
Mangaluru Karnataka |
| Type of Sponsor |
Research institution |
|
|
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 |
| POONAM MEHER |
SRINIVAS UNIVERSITY |
Departmeny of physiotherapy Srinivas University
ground floor Pandeshwar
Mangaluru
Dakshina Kannada
KARNATAKA |
6370715193
-
meherpoonam012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRINIVAS UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.Both gender
2.3 to 5 years children
3.At least 180 minutes should be spent on various physical activities.
4.No longer than one hour at a time be isolated.
5.Have 10–13 hours of good-quality sleep.
|
|
| ExclusionCriteria |
| Details |
1.Children who are on medication for allergies asthma etc
2.Children with acute or chronic illness, cardiovascular pulmonary and neuromuscular issues that impact their ability to walk (fractures recent surgery trauma or injury Pelvic pain lower limb pain Back pain)
3.Children with cognitive and developmental challenges or any other neurobehavioral problems
4.Children with profound sensory defects, such as visual or auditory impairment, may have difficulty doing or administering tests
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Nil
|
Base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Bade line |
|
|
Target Sample Size
|
Total Sample Size="188"
Sample Size from India="188"
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)
|
25/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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 TUDS test is important for measuring how well children can move and balance, but not many studies have given typical scores on the TUDS test among preschool-aged children. This lack of normative values may reflect in identifying whether the functional activity of a child is within the expected ranges or according to the growth parameters in a peer population. Thus, there is a need to establish the normative data among preschool children. TUDS test is standard for assessment and is a simple and easy tool that can be used in various settings to evaluate children’s mobility and balance functionality and to compare their performance with typically developing children. However, there is a lack of research on the normative value, and is yet to be established among children between 3 to 5years old.
|