| CTRI Number |
CTRI/2023/11/060250 [Registered on: 24/11/2023] Trial Registered Prospectively |
| Last Modified On: |
23/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Change in foot arch with respect to core stability exercise and intrinsic foot muscles training- a comparative study |
|
Scientific Title of Study
|
Efficacy of Core Stability exercise and Intrinsic foot training on patients with flat foot-A Comparative 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 |
Dr Saloni Sawant |
| Designation |
Post graduate student |
| Affiliation |
College of physiotherapy, sumandeep vidyapeeth deemed to be university |
| Address |
201, 2nd Floor PG classroom, College of Physiotherapy, Sumandeep Vidyapeeth deemed to be university, Waghodia, vadodara-
201, 2nd Floor PG classroom, College of Physiotherapy, Sumandeep Vidyapeeth deemed to be university, Waghodia, vadodara-
Vadodara
GUJARAT
391760
India |
| Phone |
8850729509 |
| Fax |
|
| Email |
sawantsaloni6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJaykumar Soni |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyappeth |
| Address |
101,Ground Staff room, College of Physiotherapy, Sumandeep Vidyapeeth deemed to be university, Waghodia, vadodara
101,Ground Staff room, College of Physiotherapy, Sumandeep Vidyapeeth deemed to be university, Waghodia, vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8866864021 |
| Fax |
|
| Email |
jds_1soni@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJaykumar Soni |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyappeth |
| Address |
101,Ground Staff room, College of Physiotherapy, Sumandeep Vidyapeeth deemed to be university, Waghodia, vadodara
101,Ground Staff room, College of Physiotherapy, Sumandeep Vidyapeeth deemed to be university, Waghodia, vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8866864021 |
| Fax |
|
| Email |
jds_1soni@yahoo.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Sumandeep Vidyapeeth deemed to be university, Waghodia, vadodara |
|
|
Primary Sponsor
|
| Name |
Saloni Sawant |
| Address |
College of Physiotherapy,Sumandeep Vidyapeeth Deemed to be university, Pipariya,Waghodia,Vadodara,391760 |
| 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 Sawant |
Constituent Institutes of Sumandeep vidyapeeth |
College of
Physiotherapy,
Sumandeep Vidyapeeth
deemed to be
University Piparia,
Waghodia, Vadodara
391760
Vadodara
GUJARAT
Vadodara
GUJARAT |
8850729509
sawantsaloni6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Flat foot |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To compare the effects of core stability exercise and intrinsic foot exercise in patients with flat foot |
Core stability exercises and
Intrinsic foot muscle exercise Dosage 3 days/week 10 secs hold with 10 reps |
| Intervention |
To see the effects of core stability exercise on foot arch |
exercises focuses on Core strengthening - 3 days/week for 10 secs hold 10 reps |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with flatfoot,
Patients with age group of 18-45 years,
Both genders (male and female),
Individuals understanding and knowing English language. |
|
| ExclusionCriteria |
| Details |
Subjects with history of lower limb soft tissue injury / fracture in the past one year,
Any history of surgery,
Any sign of pain in the lower limbs,
Any neurological conditions related to foot for e.g. diabetic neuropathy,
Any deformity in ankle and foot,
History of Spinal surgery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Normalized Truncated Navicular Height (NTNH)
|
outcome measures will be taken two times that is baseline data and at the end of 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Foot function index questionnaire (FFIQ) |
outcome measures will be taken two times that is baseline data & at the end of 4 weeks
|
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2023 |
| Date of Study Completion (India) |
02/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a comparative study, after CTRI registration the individuals with flat feet will be included according to the inclusion and the exclusion criteria and will be explained about the study the voluntary consent will also be taken.They will be screened pre and post by using the two outcome measures which are the normalized truncated navicular drop test and other is the foot function index questionnaire. Then they will be divided randomly into two groups by i.e one of the core stability exercise and other is the intrinsic foot training by the lottery method.Further the data will be recorded statistically |