| CTRI Number |
CTRI/2024/12/077919 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess Ankle Strength, Endurance, Flexibility and Range of motion in Bus Drivers with and Without Diabetes Mellitus |
|
Scientific Title of Study
|
Evaluation of Ankle Strength, Endurance, Flexibility and Range of motion in Bus Drivers with and without Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mehnaz Fatima Abdul Nasir |
| Designation |
MPT SCHOLAR |
| Affiliation |
MGM School of Physiotherapy, MGM Institutes of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, Room No. 115, 2nd Floor, MGM Hospital, Sector 1, Plot 1 & 2, Kamothe, Navi Mumbai, Taluka Panvel, Raigad, Maharashtra, 410209, India.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
09224789416 |
| Fax |
|
| Email |
mehnazfatima@mgmsopnm.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Shetty PT |
| Designation |
Associate Professor |
| Affiliation |
MGM School of Physiotherapy, MGM Institutes of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, Room No. 115, 2nd Floor, MGM Hospital, Sector 1, Plot 1 & 2, Kamothe, Navi Mumbai, Taluka Panvel, Raigad, Maharashtra, 410209, India.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
mshetty@mgmsopnm.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Shetty PT |
| Designation |
Associate Professor |
| Affiliation |
MGM School of Physiotherapy, MGM Institutes of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, Room No. 115, 2nd Floor, MGM Hospital, Sector 1, Plot 1 & 2, Kamothe, Navi Mumbai, Taluka Panvel, Raigad, Maharashtra, 410209, India.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
mshetty@mgmsopnm.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy, MGM Institute of Health Sciences, Room No. 115, 2nd Floor, MGM Hospital, Sector 1, Plot 1 & 2, Kamothe, Navi Mumbai, Taluka Panvel, Raigad, Maharashtra, 410209, India.
|
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy, MGM Institute of Health Sciences |
| Address |
MGM School of Physiotherapy, MGM Institute of Health Sciences, MGM Educational Campus Sector 1, Plot no. 1 and 2, Kamothe, Navi Mumbai-410209 Taluka Panvel District Raigad |
| Type of Sponsor |
Private medical college |
|
|
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 Mamta Shetty PT |
MGM School of Physiotherapy, MGM Institute of Health Sciences |
Department of physiotherapy Room No. 115, 2nd Floor, MGM Hospital, Sector 1, Plot 1 & 2, Kamothe, Navi Mumbai, Taluka Panvel, Raigad, Maharashtra, 410209, India.
Raigarh
MAHARASHTRA |
02227437866
mshetty@mgmsopnm.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Mahatma Gandhi Mission Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications, (2) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
The study will include male bus drivers aged between 18 and 65 years who are actively employed and have been driving for the Brihanmumbai Electricity Supply and Transport (BEST) or Navi Mumbai Transport for 12 hours daily. Participants will be categorized into two groups based on their diabetes mellitus status:
Those clinically diagnosed with type 2 diabetes mellitus, confirmed by standard diagnostic criteria such as HbA1c levels and fasting blood sugar levels and Healthy controls. |
|
| ExclusionCriteria |
| Details |
The study will exclude bus drivers who are actively driving for the following services: Navi Mumbai Municipal Transport (NMMT), Kalyan Dombivli Municipal Transport (KDMT), Thane Municipal Transport (TMT), and Maharashtra State Transport (MSRTC). Additionally, bus drivers operating exclusively in South Mumbai or Thane regions will not be included. Participants will also be excluded if they have a history of ankle fractures, recent accidents, or any deformities of the foot and ankle. Other exclusion factors include the presence of systemic conditions such as anemia, thyroid disease, or other autoimmune disorders. Furthermore, bus drivers diagnosed with diabetes mellitus who drive for less than 12 hours per day will not be eligible for participation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Ankle Strength- Hand held Dynamometer
2.Ankle Endurance- Single leg heel raise test
3.Ankle Flexibility- Dorsiflexion Lunge Test
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ankle Range of motion- Universal Goniometer |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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)
|
28/01/2025 |
| 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="1"
Months="0"
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
|
Diabetes mellitus is found to be more prevalent in India and the India ranks second in higher number people with diabetes mellitus, Prevalence of diabetes mellitus in India is expected to be rose by 2030 India will have 79.4 million and found to be more in urban areas than in rural area. Diabetes mellitus is found to be more common among population if persists for longer period of time can lead to motor dysfunction in the form of muscular atrophy, muscle weakness, reduced strength of muscles and even affect joint mobility, flexibility and range of motion of a particular joint and muscle size too, limitations in flexibility of joints, and range of motion, due to the reduced in muscle size it also limits muscle endurance and these starts manifest from distal part of body, most commonly affected parts are ankle and knee joint rather than proximal joint, hence more focus has to be n distal part of body. Driving vehicle specially driving the buses not only require the sufficient strength but also sufficient mobility, flexibility and driving it for prolonged period of time will require sufficient endurance of ankle complex and due to prolonged complications of diabetes mellitus these get hampered. Population in India without diabetes mellitus or population pre-diabetes mellitus may or may not have symptoms of diabetes mellitus, it can range from mild to moderate symptoms and sometimes and can remain unnoticed. There is limited research which focuses on ankle strength, endurance and flexibility in bus drivers with and without diabetes mellitus and studies which evaluate and focuses on the ankle strength, endurance, flexibility and range of motion in the bus drivers with diabetes mellitus and without diabetes mellitus. This study will make comprehensive analysis of ankle endurance, strength, flexibility and range of motion and will provide with the interventional strategies needed |