| CTRI Number |
CTRI/2019/05/019384 [Registered on: 27/05/2019] Trial Registered Prospectively |
| Last Modified On: |
27/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Handgrip strength in diabetic patients and in normal individuals |
|
Scientific Title of Study
|
Correlation of handgrip strength and handgrip endurance in diabetes mellitus patient and normal population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| - |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaspreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University Science and Technology |
| Address |
Room number 8, Ground Floor,
Department of Physiotherapy,
Health Center,
Guru Jambheshwar University Science and Technology, Hisar
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaspreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University Science and Technology |
| Address |
Room number 8, Ground Floor,
Department of Physiotherapy,
Health Center,
Guru Jambheshwar University Science and Technology, Hisar
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meenakshi |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University Science and Technology, Hisar |
| Address |
Room no.101, First floor, Department of Physiotherapy,
Guru Jambheshwar University Science and Technology, Hisar
-
Hisar
HARYANA
125001
India |
| Phone |
8199088840 |
| Fax |
- |
| Email |
meenakshi.physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self(Vandana Sharma)
Room no. 39, Girls Hostel 1, Guru Jambheshwar University Science and Technology, Hisar, Haryana, India
Pin Code 125001 |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Guru Jambheshwar University of Science and Technology, NH 10,
New Delhi- Rohtak- Fazil ka National Highway, Hisar, Haryana |
| Type of Sponsor |
Research institution |
|
|
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 |
| Vandana Sharma |
Department Of Physiotherapy |
Room No 4, Ground Floor, Health Centre, Guru Jambheshwar University of Science and Technology,Hisar
Hisar
HARYANA
Hisar
HARYANA |
9896426707
physiovandana0511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Handgrip strength and Handgrip Endurance |
Handgrip Dynamometer for measurement of Handgrip strength and endurance |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diabetes Mellitus |
|
| ExclusionCriteria |
| Details |
1. Mental Retardation
2. Cardiopulmonary diseases
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Handgrip Strength and Endurance
|
Single Time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Body Mass Index |
Single time |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
27/05/2019 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NILL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes mellitus is a global disorder in which cause High blood sugar level over a prolonged period affecting every age group. 40.9 million people in India suffering from diabetes and it is estimated by the 2030 diabetes is likely to be the 7th leading cause of death. The aim of the study is to find the correlation between hand grip strength and hand grip endurance in patient suffering form Diabetes mellitus and normal population. And it is measured by using the Hand grip Dynamometer. |