| CTRI Number |
CTRI/2024/09/073910 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Normal values of timed up and downstair test and its relation with body mass index and waist hip ratio |
|
Scientific Title of Study
|
Normative value of timed up and downstair test and its correlation with body mass index and waist hip ratio
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 |
Vashnavi Arora |
| Designation |
Student |
| Affiliation |
Maharishi markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar University, Department of Orthopaedics, Physiotherapy OPD, Room number-510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7876639852 |
| Fax |
|
| Email |
vashnaviarora01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pooja Mehra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar University, Department of Orthopaedics, Physiotherapy OPD, Room number-510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9896644741 |
| Fax |
|
| Email |
mehra.drpooja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pooja Mehra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar University, Department of Orthopaedics, Physiotherapy OPD, Room number-510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9896644741 |
| Fax |
|
| Email |
mehra.drpooja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan, 173229 |
|
|
Primary Sponsor
|
| Name |
Vashnavi Arora |
| Address |
Maharishi Markandeshwar University, Department of Orthopaedics, Physiotherapy OPD, Room number-510, Kumarhatti, Solan |
| 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 |
| Dr Pooja Mehra |
Maharishi Markandeshwar University |
Maharishi Markandeshwar University, Department of Orthopaedics, Physiotherapy OPD, Room number-510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH |
9896644741
vashnaviarora01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE MM MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NORMAL INDIVIDUALS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
TIMED UP AND DOWN STAIRS TEST |
The time required to ascend and descend a flight of stairs will be measured. A stopwatch will be used to record the time in seconds to complete each trial. Subject will be instructed to Quickly, but safely go up the stairs, turn around on the top step and come all the way down until both feet land on the bottom step. There were two handrails available on the stairs. The subjects were given the cues “ready†and “go†The TUDS score was the time in seconds from the “go†cue until the second foot returned to the bottom landing. Shorter times indicated better functional ability. Observe the individual’s consistency, use of handrails, balance and any signs of difficulty or distress. Consider the test results in the context of the individual’s overall health, physical condition and specific clinical condition |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
1. Asymptomatic individuals
2. Male and Female
3. Age between 18-26 years
4. Able to climb stairs without assistance
|
|
| ExclusionCriteria |
| Details |
1. Any balance or coordination related issue
2. Injury to lower limb, cardiac, respiratory, neurological or musculoskeletal disorder
3. Sensory impairment
4. Leaning disability
5. Hearing problem
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Timed up and downstair test |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="234"
Sample Size from India="234"
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)
|
20/09/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Stair negotiation is a complex motor task that involves significant
lower limb strength, coordination and balance. The ability to navigate stairs is critical
component of daily living activities and is often a determinant of an individual’s
independence. The TUDS test is simple to administer and requires minimal equipment.
The TUDS test used to provide a standardized, objective measure of stair-climbing
activity. Performance on stairs is required since it is the only component connected with
domestic extrinsic activity and the best predictor of independent activity in people
living in communities. The primary objective of the study is to generate normative data on
healthy individuals aged 18-26years. Secondary objective of the study is to find out
correlation between Timed up and down stairs test with body mass index and waist hip
ratio. |