| CTRI Number |
CTRI/2025/12/099582 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding How Leg Muscle Activation and Ankle Flexibility Affect the Chances of Ankle Injuries |
|
Scientific Title of Study
|
Association Between Lower Extremity Muscle Recruitment Patterns and Ankle Range of Motion as a Predictor of Ankle Injury Risk |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Athul Krishna K R |
| Designation |
PG student |
| Affiliation |
Tejasvini Physiotherapy College |
| Address |
Department of Neurological Sciences
Tejasvini Physiotherapy College
opp Anantha Padmanabha Temple
Kudupu, Mangalore
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
7306104338 |
| Fax |
|
| Email |
athulkrishna709@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Athul Krishna K R |
| Designation |
PG student |
| Affiliation |
Tejasvini Physiotherapy College |
| Address |
Department of Neurological Sciences
Tejasvini Physiotherapy College
opp Anantha Padmanabha Temple
Kudupu, Mangalore
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
7306104338 |
| Fax |
|
| Email |
athulkrishna709@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Athul Krishna K R |
| Designation |
PG student |
| Affiliation |
Tejasvini Physiotherapy College |
| Address |
Department of Neurological Sciences
Tejasvini Physiotherapy College
opp Anantha Padmanabha Temple
Kudupu, Mangalore
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
7306104338 |
| Fax |
|
| Email |
athulkrishna709@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Athul Krishna K R |
| Address |
Tejasvini Physiotherapy college, opp Anantha Padmanabha Temple, Kudupu Mangalore, 575028 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Riyas Basheer K B |
Tejasvini Physiotherapy college, opp Anantha Padmanabha Temple, Kudupu Mangalore, 575028 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Athul Krishna K R |
Tejasvini Physiotherapy College |
Department of Neurological Sciences
Tejasvini Physiotherapy College opp Anantha Padmanabha Temple kudupu Mangalore 575028
Dakshina Kannada
KARNATAKA |
7306104338
athulkrishna709@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
participate with and without history of ankle injuries |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
undergraduate or postgraduate college students between 18 to 25 years
individuals willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
history of any lower extremity injury, including ankle sprains, within last 6 weeks
any lower extremity surgery
neuropathies or balance disorders
history of any musculoskeletal conditions that may affect outcomes
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
EMG activation profile
|
20-30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of Motion of Ankle |
5-10min |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/01/2026 |
| 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="6"
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
|
This study aims to evaluate how neuromuscular activation of the tibialis anterior peroneus, and soleus muscles along with ankle joint range of motion ROM can predict ankle injury risk in physically active individuals A total of 50 participants aged 18 to 25 from Tejasvini Hospital Group of Institutions will be selected through simple random sampling It is a comparative cross sectional study conducted over 7to 8 months Data will be collected using a goniometer for ankle ROM dorsiflexion plantarflexion inversion and eversion and surface electromyography for muscle activation assessment following SENIAM guidelines Screening tools include the International Physical Activity Questionnaire Pittsburgh Sleep Quality Index and Cumberland Ankle Instability Tool Statistical analysis will include descriptive statistics normality tests Shapiro Wilk or Kolmogorov Smirnov and between group comparisons using independent t tests or Mann Whitney U tests with significance set at p lessthan 0.05 The study hypothesizes that altered muscle activation and limited ankle ROM are significant predictors of increased ankle injury risk aiding in the development of targeted prevention strategies |