| CTRI Number |
CTRI/2025/07/090825 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of ankle muscle strength and movement in both the legs of KSRTC bus drivers: A cross-sectional study |
|
Scientific Title of Study
|
Comparison of ankle dorsiflexor strength and dorsiflexion range in bilateral lower limb among KSRTC bus drivers: 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 |
Silvita Nazlin Crasta |
| Designation |
PG Student |
| Affiliation |
Father Muller college of physiotherapy |
| Address |
Father Muller College Of Physiotherapy. Dept of physiotherapy OPD No: 10
Udupi
KARNATAKA
576235
India |
| Phone |
7619241221 |
| Fax |
|
| Email |
silvitacrasta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms P Chaitra Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller college of physiotherapy |
| Address |
Father Muller college of physiotherapy, Dept of Musculoskeletal R Ward kankanady Mangaluru,
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8904760245 |
| Fax |
|
| Email |
chaitraphysio07@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms P Chaitra Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller college of physiotherapy |
| Address |
Father Muller college of physiotherapy Dept of Musculoskeletal R Ward kankanady Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8904760245 |
| Fax |
|
| Email |
chaitraphysio07@fathermuller.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Silvita Nazlin Crasta |
| Address |
Gods Grace Villa, Near Annappayya Sabha Bhavan, Trasi post, Kundapur, Udupi Karnataka, India 576235 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Silvita Nazlin Crasta |
KSRTC Bus Stand Mangaluru |
VRPR+736 Bus Stand (KSRTC OFFICE), Bejai Main Rd, Mallikatte, Bejai, Mangaluru
Dakshina Kannada
KARNATAKA |
7619241221
silvitacrasta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee (FMIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
KSRTC Bus Drivers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
Professional drivers (Manual transmission) only for 5 years or more
Drive for a minimum of 5hrs per day for 5 days in a week |
|
| ExclusionCriteria |
| Details |
Neurological disorders
Disorders of the ankle or injuries/surgeries in the previous six months
Acute and chronic swelling in the bilateral ankle
Individuals not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dorsiflexor strength :
Dorsiflexor strength in bilateral lower limb will be assessed using mechanical
dynamometer
Dorsiflexion range:
Dorsiflexion range in bilateral lower limb will be assessed using universal
goniometer |
20 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
25/07/2025 |
| 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 Applicable |
| 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
|
According to the International Labour Organisation (ILO) and earlier studies,
occupational drivers have a higher prevalence of MSDs (Musculoskeletal Disorders)
than other worker types because of their line of work. One of the main causes of early
retirements among professional drivers is work-related MSDs [1]. Professional drivers
frequently deal with bad road conditions and have significant drawbacks, including
bad posture, time constraints, extended sitting, vibrations from the vehicle-road
interface, excessive physical strain, and twisting motions while driving, all of which
can be harmful to their health and result in a WMSD (Work-related musculoskeletal
disorders) [2]. A study by Sheth A et al revealed that the prevalence of musculoskeletal
disorders among bus drivers in India was 49.2% [3]. Lower extremities are at danger
from repetitive tasks because of the increased force transfer through the legs and spine
when using the brake, clutch, and accelerator [4].
The tibialis anterior (TA) is the predominant muscle in the anterior compartment
of the lower leg, comprising about 60% of the total volume of ankle dorsiflexor
muscles, and it shares functions with extensor hallucis longus and the extensor
digitorum longus [5]. Due to the prolonged static contraction of the TA muscle, Y
Jammes et al. observed EMG indications of muscular fatigue in many of the
individuals [6].
Long-term sitting in one place can cause bad posture, restricted movement, and
repetitive strain on ankles. Although there is involvement of bilateral ankle movement
during manual transmission, the number of repetitive movements in each ankle is not
the same, and the amount of activation in tibialis anterior is different. There is a need
for comparing the muscle strength and ankle range in both ankles to check for muscle
imbalance. |