| CTRI Number |
CTRI/2021/12/038355 [Registered on: 01/12/2021] Trial Registered Prospectively |
| Last Modified On: |
29/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effects of two taping techniques and exercises on functional flat foot in adult |
|
Scientific Title of Study
|
Effects of two taping techniques and exercises on foot arch in adults with functional flat foot-A COMPARATIVE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saloni Vyas |
| Designation |
PG student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
E303,Empire estate phase 1 near ranka jewellers chinchwad pune
Dr D y Patil college of physiotherapy 3rd floor orthopedic department pimpri, pune 411018
Pune
MAHARASHTRA
411019
India |
| Phone |
9824358546 |
| Fax |
|
| Email |
vyassaloni98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Dr. D. Y. Patil College of Physiotherapy
Sant Tukaram Nagar
Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7767947939 |
| Fax |
|
| Email |
neha.kulkarni@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Dr. D. Y. Patil College of Physiotherapy
Sant Tukaram Nagar
Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7767947939 |
| Fax |
|
| Email |
neha.kulkarni@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
saloni vyas |
| Address |
E303 empire estate phase 1 near Ranka jewellers chichwad 411019 |
| Type of Sponsor |
Other [Self Funded ] |
|
|
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 |
| Saloni Vyas |
Dr. D. Y. Patil College of Physiotherapy |
Dr. D. Y. Patil College of Physiotherapy 3rd floor orthopedic department
Sant Tukaram Nagar
Pimpri, Pune - 411018
Pune
MAHARASHTRA |
9824358546
vyassaloni98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
18-30 years individuals with Functional Flat Foot |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise with APSS Taping technique |
Kinetic control and conventional exercise with APSS Taping technique 3 times in a week for 4 weeks |
| Comparator Agent |
Exercise with Navicular Taping technique |
Kinetic control and conventional exercise with Navicular Taping technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Younger individuals between the age group of 18 to 30 years.
Individuals with longitudinal arch angle less than 131 degree is low arch foot.
Individuals with Navicular Drop Test more than 10mm of drop.
Individuals with normal BMI (18.5-24.9) |
|
| ExclusionCriteria |
| Details |
Individuals with history of recent lower limb surgeries
Individuals with history of lower limb injuries
Adults having congenital flat foot
Adults having any foot or lower limb deformity
Any Neuromuscular injuries (nerve rupture, neuropathy) in the past 1 year
Adults having allergy to taping
Adults having Hypermobility of joint |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Medial Longitudinal arch |
pre and post 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Navicular Drop Test |
pre and post 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2021 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this study will provide when to treat and which taping technique would be the best and conservative treatment for adults with functional flat foot |