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CTRI Number  CTRI/2019/09/021277 [Registered on: 17/09/2019] Trial Registered Prospectively
Last Modified On: 17/09/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   effect of intrinsic foot exercise on foot posture in diabetic patient 
Scientific Title of Study   the effect of foot posture exercises on foot dysfunction in diabetic patient 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jaspreet Kaur 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar

Hisar
HARYANA
125001
India 
Phone  9466092657  
Fax  0  
Email  jaspreet248103@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jaspreet Kaur 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar

Hisar
HARYANA
125001
India 
Phone  9466092657  
Fax  0  
Email  jaspreet248103@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jaspreet Kaur 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology Hisar 
Address  Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar

Hisar
HARYANA
125001
India 
Phone  9466092657  
Fax  0  
Email  jaspreet248103@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF PHYSIOTHERAPY GURU JAMBHESHWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY HISAR 
 
Primary Sponsor  
Name  Department of Physiotherapy 
Address  Guru Jambheshwar University of Science and Technology Hisar 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sarita Panghal  Department of Physiotherapy  Department of physiotherapy room no 4 Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA 
8168050895

SaritaPanghal141@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental ethical committee of Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E08-E13||Diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  foot posture exercises  intrinsic foot exercises aerobic exercises balance exercises 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  42.00 Year(s)
Age To  73.00 Year(s)
Gender  Both 
Details  type 1 and type 2 diabetes mellitus
42 to 73 year 
 
ExclusionCriteria 
Details  neurological deficit
gangrene
skin infections
glucoma
diabetic complication neuropathy nephropathy retinopathy
myocardial infartion
hypertension
musculoskeletal disorders that may affect the collection of data 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
navicular height  navicular height 
 
Secondary Outcome  
Outcome  TimePoints 
foot posture index  pre and post foot posture index 
arch index  pre and post arch index 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   30/09/2019 
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="1"
Days="20" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Diabetes Mellitus is the chronic metabolic disorder which causes increase in blood sugar level due to insulin deficiency. There are several Diabetic complication which causes foot posture alterations consequently postural defects in patients suffering from Diabetes Mellitus. There are several exercises which are used to correct abnormalities. The clinical implication of this study is to reduce these negative impact on foot and maintain normal foot postures. 
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