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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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