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CTRI Number  CTRI/2023/09/057532 [Registered on: 13/09/2023] Trial Registered Prospectively
Last Modified On: 16/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A clinical study to see the effect of lateral thigh muscles strength on foot pressure in knee pain patients. 
Scientific Title of Study   Relationship between hip abductor muscle strength on pelvic angle and plantar pressure distribution in patients with knee osteoarthritis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nuka Deeksha Nagesh Reddy 
Designation  Post Graduate Student 
Affiliation  Manipal College of Health Professions 
Address  Upper Basement,# 98,HAL,Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital,Bangalore.

Bangalore
KARNATAKA
560017
India 
Phone  8097115125  
Fax    
Email  nuka.mhsblr2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Karvannan H 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Upper Basement, #98,HAL,Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital,Bangalore.

Bangalore
KARNATAKA
560017
India 
Phone  9986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Karvannan H 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Upper Basement, #98,HAL,Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital,Bangalore.

Bangalore
KARNATAKA
560017
India 
Phone  9986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital,Bangalore. 
 
Primary Sponsor  
Name  Manipal College of Health Professions 
Address  Upper Basement, # 98,HAL, Old Airport Road, Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital,Bangalore. 
Type of Sponsor  Research institution and hospital 
 
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 
Deeksha Nuka  Manipal Hospital  Department of Physiotherapy, Upper Basement,#98,HAL,Manipal Hospital,Old airport road, Bangalore
Bangalore
KARNATAKA 		 8097115125

nuka.mhsblr2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Of Manipal Hospital Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Participants with Unilateral OA 
 
ExclusionCriteria 
Details  Any musculoskeletal impairments involving the spine and lower extremities, neurological, vestibular impairments.
No known foot problems or other ailments such as Type 2 diabetes or neuropathy.
Patients having difficulty in understanding.
Any surgical history especially of the spine and lower limb will be excluded.
Participants having permanent visual and auditory impairments.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Plantar pressure distribution in unilateral knee Osteoarthritis
Hip abductor Strength & Pelvic angle 		 Immediate observation only at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Hip strength assessment
Pelvic angle assessment 		 Immediate observation only at Baseline 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/04/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 is a cross-sectional study to analyze the relationship between hip abductor muscle strength on pelvic angle and plantar pressure distribution in patients with knee osteoarthritis who visit the Out Patient Department of Orthopaedics and Physiotherapy. The study will target a sample of 82 individuals and will be conducted in Manipal Hospital, Old Airport Road, HAL, Bangalore. Osteoarthritis is characterized as a chronic degenerative illness that causes articular cartilage loss, bone enlargement around the joint, subchondral sclerosis and many biochemical and morphological alterations to the synovial membrane and joint capsule. The primary outcome is to assess the plantar pressure distribution in Unilateral Knee Osteoarthritis patients. The secondary outcome is to check the effect of hip abductor muscle strength and pelvic angle in patients with knee osteoarthritis. 
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