| CTRI Number |
CTRI/2024/02/063172 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
CORRELATION STUDY |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relationship of strength of muscles of core, flexibility of the Iliopsoas(group of muscles of hip) and measure of arch height in the feet in young adults with flat feet on both sides. |
|
Scientific Title of Study
|
Assessment and relationship of core endurance, Iliopsoas flexibility with navicular drop test
in young adults with bilateral flexible flat feet |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SWATI KUBAL |
| Designation |
ASSISTANT PROFESSOR(PT) |
| Affiliation |
Topiwala National Medical College and B. Y. L. Nair Charitable Hospital |
| Address |
OPD 24,PT School and Centre, Topiwala National Medical College and Dr B.Y.L Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra
Mumbai
MAHARASHTRA 400008
India
Mumbai MAHARASHTRA 400008 India |
| Phone |
8691948255 |
| Fax |
|
| Email |
swatikubal@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SWATI KUBAL |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Topiwala National Medical College and B. Y. L. Nair Charitable Hospital |
| Address |
OPD 24, PT School and Centre, Topiwala National Medical College and Dr B.Y.L. Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra
Mumbai
MAHARASHTRA 400008
India
Mumbai MAHARASHTRA 400008 India |
| Phone |
8691948255 |
| Fax |
|
| Email |
swatikubal@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
AHILYA TRIMUKHE |
| Designation |
POST GRADUATE STUDENT(PHYSIOTHERAPIST) |
| Affiliation |
Topiwala National Medical College and B. Y. L. Nair Charitable Hospital |
| Address |
OPD 24, PT School and Centre, Topiwala National Medical College and Dr B.Y.L. Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra
Mumbai
MAHARASHTRA 400008
India
Mumbai MAHARASHTRA 400008 India |
| Phone |
8850138350 |
| Fax |
|
| Email |
ahilya.trimukhe411@gnail.com |
|
|
Source of Monetary or Material Support
|
| P.T SCHOOL AND CENTRE, TOPIWALA NATIONAL MEDICAL COLLEGE AND BYL NAIR CHARITABLE HOSPITAL |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 SWATI KUBAL |
PT School and Centre, Topiwala National Medical College and B. Y. L. Nair Charitable Hospital |
OPD 24, PT School and Centre, Topiwala National Medical College and Dr B.Y.L.Nair Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra
Mumbai
MAHARASHTRA 400008
India Mumbai MAHARASHTRA |
08691948255
swatikubal@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR ACADEMIC RESEARCH PROJECTS(ECARP) PG ACADEMIC COMMITTEE TNMC AND BYL NAIR CH HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
young adults with bilateral flat feet |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1) Individuals in the age group of 18 to 25 years
2) Individuals with bilateral flexible flat feet
(navicular drop test more than 10mm)
3) Individuals willing to participate |
|
| ExclusionCriteria |
| Details |
1) Individuals having rigid flat foot
2) Individuals having congenital deformities
3) Individuals who underwent surgery around lower
limb or trunk
4) Individuals having recent injuries around lower
limb or trunk |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| navicular drop test |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
mc gill core endurance test
bubble inclinometer |
6 months |
|
|
Target Sample Size
|
Total Sample Size="47" Sample Size from India="47"
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)
|
26/02/2024 |
| 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
|
Collapse of medial longitudinal arch is known as flat foot. If the arch collapses in weight bearing position it is called and flexible flat feet. In weight bearing activities, excessive foot pronation can occur. Iliopsoas is positioned anteriorly to the hip which is a flexor of hip which pulls femur towards pelvis or pelvis towards femur. when latter movement, iliopsoas can cause anterior tilt resulting in increased lordosis. in weight bearing position in flexible flat feet, subtalar hyper pronation occurs which leads to internal rotation of tibia and femur which contributes to anterior pelvic tilt which is associated with tightness of iliopsoas muscle. Bilateral flat feet also results in more proximal lower limb dysfunctions which affects core stability. Therefore, weakness or imbalance in these muscles may contribute to collapse of medial longitudinal arch of foot and development of flexible flat feet. It is crucial to understand the relationship between core endurance, iliopsoas flexibility and navicular drop test in individuals with bilateral flat feet to develop effective preventive and therapeutic interventions. The aim is the study evaluation and relationship of core endurance, iliopsoas flexibility, and the navicular drop test in young adults with bilateral flat feet. The objectives of the study are to: 1) To assess navicular drop in
young adults with bilateral flexible flat feet using navicular drop test. 2) To
assess iliopsoas flexibility in young adults with bilateral flexible flat feet
using Thomas test. 3) To assess core endurance in young adults with bilateral
flexible flat feet using Mc gill core endurance test. 4) To compare iliopsoas
flexibility and core endurance in young adults with bilateral flexible flat
feet using Mc gill core endurance test. 5) Determine the relationship between
core endurance, iliopsoas flexibility, and the navicular drop test in young
adults with bilateral flexible flat feet. Outcome measures used will be Navicular
drop test for assessing flexible flat feet, Iliopsoas tightness using Thomas test and muscle length using
bubble inclinometer, Core endurance will be measured using Mc gill core endurance test.
All the data obtained from the participants will be kept confidential. The data
will be stored in excel sheets for analysis. Graph pad or SPSS software will be
used for analysis. If data passes normality, parametric (spearman correlation)
test will be used. If data does not pass normality, non-parametric (Pearson
correlation coefficient) test will be used. |