| CTRI Number |
CTRI/2024/05/067439 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To compare immediate effect of Kinesio taping and Rigid taping on Dynamic Balance in individuals having Flexible Flat Feet |
|
Scientific Title of Study
|
Immediate effect of Kinesio taping and Rigid taping on Dynamic Balance in individuals with Flexible Flat Feet: A Crossover 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 |
Vaishnavi Chandratre |
| Designation |
PG Student |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
DES Brijlal Jindal College of Physiotherapy, Musculoskeletal sciences department, Fergusson College Campus, Shivajinagar, Pune
Pune
MAHARASHTRA
411012
India |
| Phone |
9021937264 |
| Fax |
|
| Email |
vaishnavi141099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Apoorva Pavnaskar |
| Designation |
Assistant Professor |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
DES Brijlal Jindal College of Physiotherapy, Musculoskeletal sciences department, Fergusson College Campus, Shivajinagar, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9552631804 |
| Fax |
|
| Email |
apoorva.likhite@despune.org |
|
Details of Contact Person
Public Query
|
| Name |
Apoorva Pavnaskar |
| Designation |
Assistant Professor |
| Affiliation |
DES Brijlal Jindal College of Physiotherapy |
| Address |
DES Brijlal Jindal College of Physiotherapy, Musculoskeletal sciences department, Fergusson College Campus, Shivajinagar, Pune
MAHARASHTRA
411004
India |
| Phone |
9552631804 |
| Fax |
|
| Email |
apoorva.likhite@despune.org |
|
|
Source of Monetary or Material Support
|
| DES Brijlal Jindal College of Physiotherapy , Musculoskeletal sciences department, Fergusson College campus , Shivajinagar, 411004 |
|
|
Primary Sponsor
|
| Name |
Vaishnavi Chandratre |
| Address |
Avalon City,C3 301, In front of CME, Dapodi, Pune city 411012, Maharashtra , India |
| 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 |
| Vaishnavi Chandratre |
DES Brijlal Jindal College of Physiotherapy |
Musculoskeletal sciences department, division 1, room no. 2, Pune 411004
Pune
MAHARASHTRA |
9021937264
vaishnavi141099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DES Brijlal Jindal College of Physiotherapy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Flexible Flat Feet |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesio Taping |
Navicular sling technique to lift the medial arch of the foot
frequency- One time technique
duration- 72 hrs |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Rigid taping |
Low dye taping technique to lift the medial arch of the foot
frequency- 1 time technique
duration- 72 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age-18-40 years
Gender- Males and Females
Individuals having flexible flat feet(Navicular drop of 10 mm or more) |
|
| ExclusionCriteria |
| Details |
Rigid flat feet
lower limb deformities
history of recent foot fracture
obese individuals (BMI more than 29.9) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Y Balance Test |
Baseline, Post taping |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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)
|
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
|
in this study, immediate of of Kinesio taping and Rigid taping will be seen on individuals of age 18-40 years with flexible flat feet. 17 individuals with flexible flat feet having a navicular drop of 10mm or more will be selected and one group will be formed. Y balance test will be performed (pre taping) and the result will be calculated. participants will be randomly divided by the chit method to decide the sequence of the intervention (Kinesio/ Rigid tape) and the first intervention will be delivered. Immediately after the first intervention, y balance test will be redone. This will be followed by the second intervention, after the washout period of 72 hours. Immediately after the second intervention , Y balance test will be readministered and the results will be calculated. For doing the statistical analysis parametric tests used within the group will be paired t test and between the groups will be unpaired t test. |