| CTRI Number |
CTRI/2024/10/075750 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Reproducibility of Single Leg Hop Test in Athletes with Flat Foot. |
|
Scientific Title of Study
|
Test-retest and Inter-rater Reliability of Single Leg Hop Test in Recreational Athletes with Flat Foot. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/A |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anandita Dhingra |
| Designation |
Intern |
| Affiliation |
Department of Physiotherapy, Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9820314485 |
| Fax |
|
| Email |
anandita.dhingra@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anupama Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy, Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986451010 |
| Fax |
|
| Email |
anupama.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anandita Dhingra |
| Designation |
Intern at Department of Physiotherapy |
| Affiliation |
Department of Physiotherapy, Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9820314485 |
| Fax |
|
| Email |
anandita.dhingra@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
Anandita Dhingra |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India 576104 |
| Type of Sponsor |
Other [self] |
|
|
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 Anandita Dhingra |
Manipal College of Health Professions |
Second floor, Department of Physiotherapy, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA |
9820314485
anandita.dhingra@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital, Institutional Ethics Committee-2 (Student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Recreational athletes with 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 |
Students between 18-25 years old, both male and female. Recreational athletes with flat foot who have a practice schedule of 2-3 hours per day, 3-4 days a week, active practice/training in the past 6 months. |
|
| ExclusionCriteria |
| Details |
Any history of Ankle sprain less than 6 months, knee
injuries less than 6 months, and acute pain in the foot, knee, or hip less than 6 months. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Single leg hop test |
Baseline
5 to 7 days post-baseline measurement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Navicular drop test, Foot Posture Index-6 |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
03/11/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is being conducted to find the reproducibility of the single leg hop test in recreational athletes with flat foot. The test-retest reliability and the inter-rater reliability of this test will be tested in flat footed recreational athletes. Screening of the flat foot will be done using the navicular drop test and foot posture index-6. At the end, the data collected will be statistically analyzed and published. |