| CTRI Number |
CTRI/2022/09/045369 [Registered on: 09/09/2022] Trial Registered Prospectively |
| Last Modified On: |
08/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Decreased upper body strength in diabetic mellitus |
|
Scientific Title of Study
|
Relationship of reduced upper extrimity muscle strength in type 2 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 |
DrJaspreet kaur |
| Designation |
Associate professor |
| Affiliation |
,GJUST Hisar-125001 |
| Address |
Room no.8 Department of physiotherapy health center, Guru Jambheshwar university of science and technology,Hisar
Department of physiotherapy, GJUST, Hisar- 125001
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
Jaspreet248103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJaspreet kaur |
| Designation |
Associate professor |
| Affiliation |
,GJUST Hisar-125001 |
| Address |
Room no.8 Department of physiotherapy health center, Guru Jambheshwar university of science and technology,Hisar
Department of physiotherapy, GJUST, Hisar- 125001
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
Jaspreet248103@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJaspreet kaur |
| Designation |
Associate professor |
| Affiliation |
,GJUST Hisar-125001 |
| Address |
Room no.8 Department of physiotherapy health center, Guru Jambheshwar university of science and technology,Hisar
Department of physiotherapy, GJUST, Hisar- 125001
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
Jaspreet248103@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self(Kusum) MPT student room no.1 girls hostle 4 guru jambeshwar university science & technology, hisar |
|
|
Primary Sponsor
|
| Name |
Department of physiotherapy |
| Address |
Department of physiotherapy university science & technology NH-10 New Delhi road- Rohtak-Sirsa-Fazil ka National highway, 125001 |
| 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 |
| Kusum |
Department of physiotherapy, health center guru jambeshwar university science& technology, hisar |
Room no. 8,ground floor; Department of physuotherapy, health center
Hisar
HARYANA |
8930953655
kusum19ladwal96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department ethics 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 |
| Intervention |
Nill |
Nill |
| Comparator Agent |
Nill |
Nill |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age grouo 35 to 60years.
2.Both male and females.
3.Duration of diabetes mellitus more than 3 years. |
|
| ExclusionCriteria |
| Details |
1.Age more than 60
2.Nerve injury
3. Alcoholic & smokers
4. Heart disease
5. Presence of thyroid autoimmune disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Upperlimb muscle strength
2.Grip strength |
Single time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shoulder pain & disability index |
Single time |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/09/2022 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To determine the severity of , and relationship of , upper extermity impairments, pain & disability in patients with diabetes mellitus type 2 , and to comapare upper extremity impairment in patients with diabetes with non - diabetic participants. |