| CTRI Number |
CTRI/2024/07/070468 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing The Strength Of Gluteus Maximus Muscle And Alignment Of Foot Position In Patients With Plantar Fasciitis |
|
Scientific Title of Study
|
Effect Of Gluteus Maximus Strength On Foot Posture In Patients With Plantar Fasciitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jecika Dsouza |
| Designation |
1st Year MPT student |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller Medical College
Department of Physiotherapy
Basement 3rd Room
Kankanady
Mangalore-575002
Karnataka, INDIA
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9591115029 |
| Fax |
|
| Email |
jecikadsouza622@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ms Leah Mohandas |
| Designation |
Professor |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller Medical College
Department of Physiotherapy
Basement 3rd Room
Kankanady
Mangalore-575002
Karnataka, INDIA
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9739863768 |
| Fax |
|
| Email |
leahdas86@fathermuller.in |
|
Details of Contact Person Public Query
|
| Name |
Jecika Dsouza |
| Designation |
1st Year MPT student |
| Affiliation |
Father Muller College of Physiotherapy |
| Address |
Father Muller Medical College
Department of Physiotherapy
Basement 3rd Room
Kankanady
Mangalore-575002
Karnataka, India
Dakshina Kannada KARNATAKA 575002 India |
| Phone |
9591115029 |
| Fax |
|
| Email |
jecikadsouza622@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jecika Dsouza
Father Muller Medical College
Department of Physiotherapy
Basement 3rd Room
Kankanady
Mangalore-575002
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Jecika Dsouza |
| Address |
Father Muller Medical College
Father Muller Road,
kankanady,
Mangalore-575002
Karnataka, INDIA |
| 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 Leah Mohandas |
Father Muller College of Physiotherapy |
Father Muller Medical College
Department of Physiotherapy
Basement 3rd Room
Kankanady,
Mangalore-575002
Karnataka, India Dakshina Kannada KARNATAKA |
9739863768
leahdas86@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of plantar fasciitis
Unilateral plantar fasciitis patients |
|
| ExclusionCriteria |
| Details |
History of any surgery in lower extremity (past 6 months)
Lower extremity pathologies-painful conditions affecting hip, knee, ankle and low back pain
Patients with neurological disorder
Pregnancy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Isometric muscle strength of the gluteus maximus muscle using Hand-held dynamometer |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Foot posture using foot posture index |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
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)
|
25/07/2024 |
| 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="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
|
Plantar fasciitis is a painful
condition that occurs when the tissue connecting the heel to toes becomes
irritated and inflamed. This is often caused by strain on the tissue usually
from repetitive activities like running, but it can also happen due to injury. This
condition accounts for about 10% of runner-related injuries, 11% to 15% of all
foot symptoms, 10% of the general population with 83% of these patients being
active working adults between the ages of 25 and 65 years old. Two
main factors that contribute to plantar fasciitis are flat feet that is feet
that roll inward too much or high arches, which can put extra stress on the
tissue. There is a connection between the hip and the foot through myofascial
tracks. If the gluteus maximus muscle (in the buttocks) is weak, it can change
the alignment of the hip joint, which may contribute to foot problems. Hence,
the need of the study is to identify the association between plantar fasciitis
and gluteus maximus muscle strength. |