| CTRI Number |
CTRI/2019/09/021238 [Registered on: 13/09/2019] Trial Registered Prospectively |
| Last Modified On: |
12/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare intrinsic foot muscles exercises and extrinsic foot muscles exercises on foot posture of patients with outward feet. |
|
Scientific Title of Study
|
Effect of intrinsic foot muscle exercises versus extrinsic foot muscle exercises on foot posture of patients with pronated feet: Comparative Study.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalpana Bamaniya |
| Designation |
Post graduate Scholar |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Room no-3,
Musculoskeletal and Sports Department,
First Floor,
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway,
Rajkot, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
8320121653 |
| Fax |
|
| Email |
kbamaniya819@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krupa Raithatha |
| Designation |
Assistant Professor |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Staff Room no:1,
Ground Floor,
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway,
Rajkot, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9898141466 |
| Fax |
|
| Email |
krupa.raithatha@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kalpana Bamaniya |
| Designation |
Postgraduate Scholar |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Room No-3
Musculoskeletal and Sports Department,
First Floor,
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway,
Rajkot, Gujrat, India
Rajkot
GUJARAT
360020
India |
| Phone |
8320121653 |
| Fax |
|
| Email |
kbamaniya819@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| RK Physiotherapy Rehabilitation and Research Center |
| School of Physiotherapy, RK University |
|
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Primary Sponsor
|
| Name |
Kalpana Bamaniya |
| Address |
Room No-3,
Musculoskeletal and Sports Department,
First Floor,
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway,
Rajkot, Gujrat, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kalpana Bamaniya |
RK Physiotherapy Rehabilitation and Research Center |
Room no:2,Physiotherapy department, Ground floor,
80 feet Road,opp.Meghani Rang Bhavan,
Bhakti Nagar,
Rajkot.
Rajkot
GUJARAT |
8320121653
kbamaniya819@rku.ac.in |
| Kalpana Bamaniya |
Shree putliba udhyog mandir trust |
Bhaktinagar circle, oppositeto geeta mandir, bhaktinagar society,Bhaktinagar,Rajkot
Rajkot
GUJARAT |
8320121653
kbamaniya819@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, SPT, RKU. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M99-M99||Biomechanical lesions, not elsewhere classified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Foot posture index,
Navicular drop test,
Arch index
|
Foot posture index,
Navicular drop test,
Arch index
|
| Intervention |
Intrinsic Foot Muscles exercises and
Extrinsic Foot Muscles exercises |
Intrinsic Foot Muscles exercises
and
Extrinsic Foot Muscles exercises for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Score of Foot Posture Index > 6.
Normal BMI: 18.5 to 24.9 Kg/m2 |
|
| ExclusionCriteria |
| Details |
Individuals who have presentation of any traumatic injuries like fractures.
Individuals with associated congenital abnormality. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
Foot posture index,
Navicular drop test
|
Day 1 And After 4 weeks
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Arch index |
Day 1 And After 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
14/09/2019 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
BACKGROUND: Pronated feet is defined as a excessive subtalar joint pronation. The medial longitudinal arch (MLA) plays an important role in shock absorbance and energy transfer during walking. Arch function depends on the shape of the foot, bony structure, ligamentous stability, and muscular fatigue. The foot posture index (FPI-6) is used for multidimensional and comprehensive evaluation of the feet. The total FPI-6 result allows to classify the foot into the neutral, supination and pronation. AIM: To Check The Effect of Intrinsic Foot Muscle Exercise Verses Extrinsic Foot Muscle Exercise In Patients With Pronated Foot. OBJECTIVE: Objective of the study is to check the effect of intrinsic foot muscle exercises and extrinsic foot muscle exercises on foot posture and on height of medial longitudinal arch in patients with pronated foot. METHODOLOGY:- Total 30 Subjects will be Included in Study according to Selection Criteria. They will be divided into 2 Groups, 15 Subjects in each group. In Group 1 Intrinsic Foot Muscles exercises will be given. In Group 2, Extrinsic Foot muscle exercises will be given for 4 weeks. Outcome Measures for the study are Foot posture index, Arch index and Navicular drop test, which will be taken on day 1 and after 4 weeks. |