| CTRI Number |
CTRI/2024/11/077280 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Battery of Balance Tests Assessing Diurnal Variation in Balance. |
|
Scientific Title of Study
|
Battery of Static and Dynamic Balance Tests for Assessing Diurnal Variation in Balance among Young Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naseela |
| Designation |
Master of Physiotherapy |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College, University road, Deralakatte, Mangaluru, 575018
Yenepoya Department of Physiotherapy and occupational therapy, 7th floor, main block (emergency department block)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9902679866 |
| Fax |
|
| Email |
naseelanas66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Naseela |
| Designation |
Master of Physiotherapy |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College, University road, Deralakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9902679866 |
| Fax |
|
| Email |
naseelanas66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naseela |
| Designation |
Master of Physiotherapy |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College, University road, Deralakatte, Mangaluru, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9902679866 |
| Fax |
|
| Email |
naseelanas66@gmail.com |
|
|
Source of Monetary or Material Support
|
| assessing balance among young adults, conducted at Yenepoya Physiotherapy College, Mangaluuru |
|
|
Primary Sponsor
|
| Name |
Naseela |
| Address |
Yenepoya Physiotherapy College, University road, Deralakatte, Mangaluru, 575018 |
| Type of Sponsor |
Other [Self funding type] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Naseela |
S.M.MANZIL
D. No. 5-T-1/2 Priyadarshini road, Angaragundi, Baikampady, 575011 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Naseela |
Yenepoya Physiotherapy College |
Department of Physiotherapy
Dakshina Kannada
KARNATAKA |
9902679866
naseelanas66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Young Adults |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
a. Young adults of both Genders aged between 18- 30 years.
b. Able to stand unaided. |
|
| ExclusionCriteria |
| Details |
a. Vestibular disorders.
b. Acute and Chronic Ankle instability.
c. Recent illness or injury.
d. Chronic sleep disorders.
e. Visual impairments. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Unipedal Stance Test for assessing static balance,
Stork Stance Balance Test for assessing static balance, Sharpened Romberg Test for assessing static balance.
Dynamic Leap Balance Test for assessing dynamic balance, Star Excursion Balance Test for assessing dynamic balance, Four Square step test for assessing dynamic balance |
Unipedal Stance Test,
Stork Stance Balance Test, Sharpened Romberg Test.
Dynamic Leap Balance Test, Star Excursion Balance Test, Four Square step test will be assessed in the morning at 09:30 am and 02:30 pm in the afternoon. The tests will be repeated for the same participants on the next day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
17/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
112 Young adults are included in the study to assess static and dynamic balance using Unipedal stance test, Sharpened Romberg test, Stork stance test, Four square step test, Star excursion balance test, Dynamic leap balance test will be assessed in the morning and afternoon for two consecutive days. This study aims to assess the diurnal variation in balance. |