| CTRI Number |
CTRI/2023/09/057382 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
08/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out if there is any connection between the muscles at the back of the thigh and the position of the foot in adults. |
|
Scientific Title of Study
|
Correlation of hamstring strength and foot posture in adults -a cross sectional 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 |
Ms Mascarenhas Ninoshka Salvita |
| Designation |
MPT |
| Affiliation |
Father Muller Medical College |
| Address |
Father Muller Medical College,
Department of Physiotherapy,
kankanady, Mangalore- 575002
Opposite SBI bank, Surban Wado,
Pernem Town, North Goa, 403512
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9075758378 |
| Fax |
|
| Email |
salvita6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Leah Mohandas |
| Designation |
Associate professor |
| Affiliation |
Father Muller Medical College |
| Address |
Father Muller Medical College,
Department of Physiotherapy,
kankanady, Mangalore- 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9739863768 |
| Fax |
|
| Email |
leahdas86@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Leah Mohandas |
| Designation |
Associate professor |
| Affiliation |
Father Muller Medical College |
| Address |
Father Muller Medical College,
Department of Physiotherapy,
kankanady, Mangalore- 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9739863768 |
| Fax |
|
| Email |
leahdas86@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical college, Kankanady,Mangalore, Dakshin K Kannada, Karnataka,- 575002 |
|
|
Primary Sponsor
|
| Name |
Father muller Medical College |
| Address |
Father muller Medical College, Kankanady, Mangalore - 575002 |
| Type of Sponsor |
Private medical 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 |
| Ms Mascarenhas Ninoshka |
Father Muller Medical College |
Department of Physiotherapy, OPD
Dakshina kannada
Karnataka
Dakshina Kannada
KARNATAKA |
9075758378
salvita6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics committee (FMIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Foot abnormalities |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All healthy adults |
|
| ExclusionCriteria |
| Details |
Individuals with; Past h/o injury to lower limb within 1yr, Lower limb surgeries within 1 year, Congenital foot deformities, Limb length discrepancy, Significant neurological conditions, directly and indirectly, affecting the lower limb, Low back pain with neurological signs, Wounds/ ulcers on foot, heel pain, People with psychiatric conditions/ not co-operative |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| hand held dynamometer |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="103"
Sample Size from India="103"
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)
|
18/09/2023 |
| 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="1"
Months="0"
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
|
Foot pain is an important challenge faced clinically and in public health as it negatively affects the quality of life and physical functioning of people. Causes of foot pain can be as trivial as choosing the wrong footwear. Studies have shown clinical and epidemiological interdependence between the foot and proximal joints. Not only intrinsic foot muscles but the proximal hip muscles have an effect on the foot. The foot and hamstring are a part of the same anatomy train ie, the superficial backline. The foot is an important component in three other anatomy trains as well. The superficial backline is directly involved in maintaining the longitudinal arch of the foot hence any abnormality in the foot is likely to be transmitted to the proximal parts of the fascia. The proximal parts can also have an effect on the foot. Since foot pronation is impacted by valgus movements and foot varus is affected by foot supination is affected by varus movement at the knee, there can be an increased stress on the plantar fascia which in turn may increase forefoot and hindfoot pressure. A study was conducted to check the lower extremity muscle performance and foot pressure in patients who have plantar fasciitis (PF) with and without flat foot posture, and found that there is a significant difference in the performance of the muscle in patients with PF with various foot postureThis study aims to assess if the strength of the hamstring muscle complex has any effect on foot posture.
RESEARCH QUESTION Is there a correlation between hamstring muscle strength and foot posture in healthy adults?
ALTERNATIVE HYPOTHESIS (H1): A correlation exists between hamstring strength and foot posture in healthy adults.
NULL HYPOTHESIS (H0): There is no correlation between hamstring strength and foot posture in healthy adults. |