| CTRI Number |
CTRI/2022/06/043313 [Registered on: 16/06/2022] Trial Registered Prospectively |
| Last Modified On: |
11/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Decreased muscle power and hand function in patients with diabetes. |
|
Scientific Title of Study
|
Prevalence of Decreased Muscle Activity and Manual Dexterity in Patients with Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaspreet kaur |
| Designation |
Associate professor |
| Affiliation |
Department of physiotherapy, Guru Jambheshwar university of science and technology, hisar |
| Address |
Room no.8 Department of physiotherapy Health center,Guru Jambheshwar university of science and technology, Hisar
Department of physiotherapy, Guru Jambheshwar university of 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 |
Associate professor |
| Affiliation |
Department of physiotherapy, Guru Jambheshwar university of science and technology, hisar |
| Address |
Room no.8 Department of physiotherapy Health center,Guru Jambheshwar university of science and technology, Hisar
Department of physiotherapy, Guru Jambheshwar university of science and technology, Hisar
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
Jaspreet248103@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaspreet kaur |
| Designation |
Associate professor |
| Affiliation |
Department of physiotherapy, Guru Jambheshwar university of science and technology, hisar |
| Address |
Room no.8 Department of physiotherapy Health center,Guru Jambheshwar university of science and technology, Hisar
Department of physiotherapy, Guru Jambheshwar university of science and technology, Hisar
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kavita Rani (self) Department of Physiotherapy Guru Jambheshwar university, hisar, haryana |
|
|
Primary Sponsor
|
| Name |
Guru Jambheshwar university |
| Address |
Department of physiotherapy Guru Jambheshwar university 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 |
| Kavita Rani |
Guru Jambheshwar university, department of physiotherapy |
Room no 8,ground floor, health center , Guru Jambheshwar university of science and technology
Hisar
HARYANA |
7056523151
ravindergodara29080@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: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetes mellitus patients,
Healthy participants. |
|
| ExclusionCriteria |
| Details |
Below 35 year and above 60 year were excluded, neuropathy, autoimmune disease, rheumatoid arthritis, history of stroke and other neurological diseases. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Amplitude |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| RMS |
One time |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
23/06/2022 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
.This study is used to estimating the muscle activity and manual function in diabetes mellitus patients and compare with healthy participants, .A total 110 participants included, 55 diabetic and 55 healthy . .The muscle activity is checked by using surface EMG, and manual function is checked by using box and block test. . Study takes 2 month of period of time. |