| CTRI Number |
CTRI/2023/11/060161 [Registered on: 22/11/2023] Trial Registered Prospectively |
| Last Modified On: |
21/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation between knee Cap position and Foot Arch in Adults |
|
Scientific Title of Study
|
Association Between Patellar Malalignment and Flatfoot in Adults |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ganesh Balthillaya M |
| Designation |
Assistant Professor (Selection Grade) |
| Affiliation |
Manipal college of Health Professions, MAHE, Manipal |
| Address |
Department Of Physiotherapy,MCHP,MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh Balthillaya M |
| Designation |
Assistant Professor (Selection Grade) |
| Affiliation |
Manipal college of Health Professions, MAHE, Manipal |
| Address |
Department Of Physiotherapy,MCHP,MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh Balthillaya M |
| Designation |
Assistant Professor (Selection Grade) |
| Affiliation |
Manipal college of Health Professions, MAHE, Manipal |
| Address |
Department Of Physiotherapy,MCHP,MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal college of health professions, Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, MAHE, Manipal |
| Type of Sponsor |
Other [Private Health Profession College] |
|
|
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 |
| Ganesh Balthillaya M |
Kasturbha Hospital |
Department of Physiotherapy,
Room no 4
Udupi
KARNATAKA |
9448263631
ganesh.bm@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Inistitutional 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 |
| Intervention |
Nill |
nill |
| Comparator Agent |
nill |
nill |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults with and without flat feet
2. Age group of 18-60 years
3. Male and female
|
|
| ExclusionCriteria |
| Details |
1. Any structural lower limb deformities.
2. Symptomatic musculoskeletal conditions of the Lower limb
3. Recent surgery or injury to the ankle or knee joint
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Navicular drop test in mm
-Presence and absence of flatfoot
2. Patella mediolateral malposition in mm
3. Presence of medial or lateral tilt
4. Presence of patella rotation in angle
5. Presence/ absence of Posterior tilt of the patella
|
At base line
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nill |
nill |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
01/12/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Flatfoot is one of the common deformity of foot. Flat foot can alter the biomechanics of lower limb and can cause deviation in tibial rotation, varus of knee, altration in patellar position,tracking related deviations. current study is aimed to find the association between flatfoot and patellar mal-alignment. 124 healthy individuals will be screened for flatfoot and presence of different patellar mal-alignment including lateral shift, lateral tilt, lateral rotation and posterior tilt of patella using McConial assesment method.Chi square test will be used to find the association between patellar position and flatfoot.
|