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CTRI Number  CTRI/2020/03/024117 [Registered on: 20/03/2020] Trial Registered Prospectively
Last Modified On: 25/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Hindrance while running, training and change of direction in athletes with multiple episodes of ankle sprain  
Scientific Title of Study   Functional performance deficits in athletes with chronic ankle instability 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhura S Jamsandekar 
Designation  Post Graduate 
Affiliation  Kasturba Medical College  
Address  Department of physiotherapy, centre for basic sciences, Kasturba medical college, Bejai, Mangalore 575004

Dakshina Kannada
KARNATAKA
575004
India 
Phone    
Fax    
Email  madhurajams11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Charu Eapen 
Designation  Professor and Head  
Affiliation  Kasturba Medical College 
Address  Department of physiotherapy, centre for basic sciences, Kasturba Medical College, Bejai, Mangalore 575004

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9986024551  
Fax    
Email  charu.eapen@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Charu Eapen 
Designation  Professor and Head  
Affiliation  Kasturba Medical College 
Address  Department of physiotherapy, centre for basic sciences, Kasturba Medical College, Bejai, Mangalore 575004

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9986024551  
Fax    
Email  charu.eapen@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of higher education Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 
 
Primary Sponsor  
Name  Manipal academy of higher education 
Address  department of physiotherapy, centre for basic sciences, Kasturba medical college, Bejai, Mangalore 575003 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Madhura S Jamsandekar  Kasturba Medical College  Department of physiotherapy, centre for basic sciences, Bejai, Mangalore 575004
Dakshina Kannada
KARNATAKA 		 7795469938

madhurajams11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Ankle Sprain 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Both genders with age 18 years to 30 years.

2. History of at least 1 acute ankle sprain that resulted in inflammation and impaired physical activity. Initial ankle sprain which occurred ≥12 months prior to testing.

3. The most recent sprain should be ≥3 months.

4. ≥2 episodes of “giving way” and/or recurrent ankle sprain and/or feelings of instability at the ankle 6 months prior to the study enrollment that does not result in an ankle sprain.

5. For athletes with bilateral ankle sprain the ankle with lowest CAIT score will be selected.

6. Cumberland Ankle Instability Tool (CAIT) score of 24 or less

7. Member of a sports team and participating in competitive matches at University level, district level, state level or National level
 
 
ExclusionCriteria 
Details  1. Individuals with history of previous surgeries of lower extremity musculoskeletal structures including bone, ligaments and/or nerve injury affecting the performance in agility test.

2. History of any ankle fracture in either lower limb requiring realignment.

3. Acute injury to musculoskeletal structures of lower limb (sprain, strain or fracture) in the 3 months prior to testing. (especially ACL injuries)

4. Individuals with any upper extremity injury/surgery affecting the performance of tests.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Speed, agility and change of direction test score calculated in seconds.

Agility calculated using Illinois agility test in seconds.


 		 Illinois agility scores Excellent if score for males less than 15.2
females less than 17.0
Above Average males 15.2 - 16.1
females 17.0 - 17.9
Average males 16.2 - 18.1 females 18.0 - 21.7
Below Average males 18.2 - 19.3
females 21.8 - 23.0
Poor males 19.3
females more than 23.0 
 
Secondary Outcome  
Outcome  TimePoints 
Cumberland ankle instability scale   score less than 24  
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/03/2020 
Date of Study Completion (India) 27/02/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="28" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Studies have shown that individuals with chronic ankle instability demonstrate increased variability of ankle kinematics at high running velocity as compared to individuals without ankle instability which may best reflect the sensorimotor deficits in athletes with chronic ankle instability. Change of direction, agility and speed play an important role for athletes.Therefore the purpose of this study is to assess speed and change of direction of athletes with chronic ankle instability so that it helps to design a rehab protocol in future which will address these components of functional performance which may be reduced in these athletes. Thus, if the speed and change of direction time is reduced in athletes with chronic ankle instability it would be beneficial to address the deficits in the rehab protocol in future.  
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