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
|
|
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
|
|
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. |