| CTRI Number |
CTRI/2025/02/080209 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of balance among Type 2 Diabetes Mellitus patients |
|
Scientific Title of Study
|
Evaluation of Balance among patients with Type 2 Diabetes Mellitus A Cross Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishnavi Singh |
| Designation |
MPT Student |
| Affiliation |
School of Health Sciences/Chhatrapati Shahuji Maharaj University |
| Address |
Department of Physiotherapy, School of Health Sciences, CSJMU Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
7523081424 |
| Fax |
|
| Email |
vaishuabpt1207@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apoorva Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Paramedical Sciences, Rama University |
| Address |
Dept. of Physiotherapy, Faculty of Paramedical Sciences, Rama University, Mandhana- Kanpur
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
8953634686 |
| Fax |
|
| Email |
apoorvasrivastava.rips@ramauniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apoorva Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Paramedical Sciences, Rama University |
| Address |
Dept. of Physiotherapy, Faculty of Paramedical Sciences, Rama University, Mandhana- Kanpur
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
8953634686 |
| Fax |
|
| Email |
apoorvasrivastava.rips@ramauniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Health Sciences, Department of Physiotherapy SHS 106 CSJMU Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 |
| Dr Apoorva Srivastava |
SCHOOL OF HEALTH SCIENCES PHYSIOTHERAPY OPD |
Department of Physiotherapy
Physiotherapy OPD
SHS 106 CSJMU
Kanpur Nagar
UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH |
8953634686
apoorvasrivastava.rips@ramauniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethical Committee, CSJMU, Kanpur |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Type 2 Diabetes Mellitus, Both male and female, Having Type 2 Diabetes Mellitus at least from 5 years |
|
| ExclusionCriteria |
| Details |
Patients with Diabetic Neuropathy, Impaired mobility, Patients having any other type of sensory loss in lower limb, Patient involved in any type of physical activity for more than 2 hours, Lower limb amputation or fracture |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mini Balance Evaluation System Test
|
at baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Clinical Test for Sensory Interaction on Balance |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="163"
Sample Size from India="163"
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)
|
20/02/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background of the Study - Type 2 Diabetes Mellitus is among one of the most common global heath problems. There are several evidences available that says there are development of neuropathic symptoms overtime in Type 2 Diabetes Mellitus Patient that creates challenges to maintain proper balance.
Aim of the Study - The aim of this study is to evaluate whether there is any balance impairment in patients With Type 2 Diabetes Mellitus without Neuropathy.
Method - It will be a cross sectional study with 163 participants. Samples will be collected by using purposive sampling method based on inclusion and exclusion criteria. Then the participants will be provided with an informed consent form to ensure their voluntary participation. Demographic details of the patients will be done using the screening tool Michigan Neuropathy Screening Instrument for ruling out the symptoms of neuropathy. After that balance will be assessed using Mini Balance Evaluation System Test and Modified Clinical Test for Sensory Interaction on Balances.
Proposed Results - Lastly the details obtained will be analyzed using SPSS software. The results might show a balance impairment in patients with Type 2 Diabetes Mellitus without Neuropathy. Finally the results will be published.
Keywords - Type 2 Diabetes Mellitus, Balance, Neuropathy |