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CTRI Number  CTRI/2024/11/076664 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of single task task versus dual task training on football players in ankle instability  
Scientific Title of Study   Efficacy of single task versus dual task training on balance and functional performance in football players with functional ankle instability  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karthika P 
Designation  PhD scholar  
Affiliation  SAVEETHA COLLEGE OF PHYSIOTHERAPY 
Address  C5 room 5th floor, Health Sciences Block, Saveetha college of physiotherapy, Saveetha Institute of Medical and Technical Science, Thandalam

Chennai
TAMIL NADU
602105
India 
Phone  7871273813  
Fax    
Email  karthikapachiyappan30@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Vinodhkumar Ramalingam  
Designation  Professor 
Affiliation  Saveetha College of Physiotherapy  
Address  A5,5th Floor, Health sciences block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Science, Thandalam

Chennai
TAMIL NADU
602105
India 
Phone  8760563032  
Fax    
Email  vinodhkumar.scpt@saveetha.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Prathap Suganthirababu  
Designation  Professor and Principal  
Affiliation  Saveetha College of Physiotherapy  
Address  Office of the principal, 4th floor, Health Science Block, Saveetha College of Physiotherapy, Saveetha Institute o Medical and Technical Sciences, Thandalam

Chennai
TAMIL NADU
602105
India 
Phone  9840340195  
Fax    
Email  research.scpt@saveetha.com  
 
Source of Monetary or Material Support  
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical sciences, Thandalam, Chennai, Tamil Nadu, India, Pincode-602105 
 
Primary Sponsor  
Name  Dr Karthika P 
Address  Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical sciences, Thandalam, Chennai, Tamil Nadu, India, Pincode-602105  
Type of Sponsor  Other [self] 
 
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 
E SIVAKUMAR  Soccer Lions Football Club  Department of sport, ground floor, NO.5/289 Drr Nagar, Play Ground, Senneerkuppam, Poonamallee, Chennai- 600056
Thiruvallur
TAMIL NADU 		 8015418817

sangeethajoe93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
SMCH-INSTITUTIONAL ETHICS COMMITTEE  Approved 
soccer lions football club  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  FUNCTIONAL ANKLE INSTABILITY IN FOOTBALL PLAYERS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Functional Ankle Instability in Football Players  The 82 participants will be recruited with complaints of functional ankle instability and provided with CAIT Cumberland ankle instability tool questionnaire and included for this study. Informed consent and an information sheet will be obtained from all participants. Included participants will be undergoing pretest such as Figure of 8 hop test and square hop test for functional performance. Balance Error Scoring System BESS and Y balance test for balance. CAIT questionnaire for functional ankle instability. Surface EMG for muscles. Ultrasonogram to find out the Ligaments injury in ankle. After completion of the pre test, Participants will be allocated into two groups by random methods as Group A and Group B. Group A will be receiving Single task training and Group B will be receiving dual task training program for 3 months 4 weeks 5 days per weeks. Experimental Group A Single Task Trainings Week 1, Unstable surface, Stands on two legs on the to 3 Sets, 10 rep 30 sec hold. Week 2, Unstable surface, stands on two legs on the toe and left and Right weight shift 3 sets, 10 rep 30sec hold. Week 3, Unstable surface, Single leg stance, Single leg T stance 3 Sets, 10 rep 30 sec hold. Week 4, Floor(ground), Cone agility zigzag 63 3 Sach cones were placed parallel to each other at 3 meters and the subject were made to run zigzag and bounced away the thrown football 3Sets, 10 rep 30 sec hold. Treatment parameters 5 sessions/week, 10 rep of 3sets, rest time 1min per each exercise variation. Experimental Group B Dual Task Trainings Week 1, Unstable surface, stands on two legs on the toe and catch the thrown red ball on right hand, yellow ball on left hand and white ball on both hands 3 sets, 10 rep, 30 sec hold. Week 2, Unstable surface, stands on two legs on the toe and left and right weight shift and hit the thrown Football with head 3 Sets, 10 rep, 30 sec hold. Week 3, Unstable surface, During Single leg stance the subject has done 1 touch bounce or 2 touch away of the thrown football. During Single Leg T stance, the subject has placed the given balls from hand to the floor 3 Sets, 10 rep, 30 sec hold. Week 4, Floor(ground), Along with Cone agility (zigzag), the subject has bounced the thrown ball and said the color of the Sach cones showed at the left side of the subject 3 Sets, 10 rep, 30 sec hold. Treatment parameters 5 sessions/week, 10 rep of 3sets, rest time 1min per each exercise variation. At the end of the 4 weeks, data will be tabulated for both experimental groups. Study duration: -A 3months, 4 -weeks program, performed 5 days per week, 1 hour per session 
Comparator Agent  SINGLE TASK TRANING   Single Task Trainings Week 1, Unstable surface, Stands on two legs on the to 3 Sets, 10 rep 30 sec hold. Week 2, Unstable surface, stands on two legs on the toe and left and Right weight shift 3 sets, 10 rep 30sec hold. Week 3, Unstable surface, Single leg stance, Single leg T stance 3 Sets, 10 rep 30 sec hold. Week 4, Floor(ground), Cone agility zigzag 63 3 Sach cones were placed parallel to each other at 3 meters and the subject were made to run zigzag and bounced away the thrown football 3Sets, 10 rep 30 sec hold. Treatment parameters 5 sessions/week, 10 rep of 3sets, rest time 1min per each exercise variation. Study duration: -A 3months, 4 -weeks program, performed 5 days per week, 1 hour per session 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  17.00 Year(s)
Gender  Male 
Details  Age 12-17 years (an epidemiological study revealed that most ankle sprains occurred in the 12 to17-year-olds)
Sex-only male subject
Subjects with post injury of ankle sprain with duration of 2-3 months.
Grade II ankle sprain
CUMBERLAND ANKLE INSTABILITY TOOL (CAIT)
The purpose of this questionnaire is to assess for functional ankle instability without requiring
comparison to the contralateral ankle as well as for allowing for grading of the
severity of the instability. The 9-question survey has scores ranging from 0 to 30,
with higher scores indicating higher stability.
The subjects who scored less than 25 out of 30 in CAIT QUESTIONNAIRE were
selected and divided into 2 groups and explained about the study.
SONOGRAPHY
The use of diagnostic sonography for detecting ligamentous lesions of
the ankle is growing as technology has become more affordable and available. Diagnostic sonography provides an inexpensive imaging
option that is versatile due to its portability and appealing to many patients because
it does not expose them to radiation or enclosures. Also, it can be used during the
acute phase of an ankle sprain with little patient setup and without stressing the
joint. The evidence suggests that diagnostic sonography offers moderate to strong
confirmation of lateral ligamentous injury in patients with suspected ankle sprain.
Reported sensitivities for identifying ATF in patients with acute ankle sprain using
ultrasound ranged from 94% to 100% and specificities ranged from 50% to 100%
 
 
ExclusionCriteria 
Details  Recent surgery and Recent fracture
Bone tumors
Football players with grade 3 ankle sprain
Neurological conditions like cerebellar ataxia.
Previous history of foot drop.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
BALANCE ERROR SCORING SYSTEM(BESS)  Baseline to 4 weeks of Post-Intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Y-BALANCE  Baseline to 4 weeks 
SURFACE EMG
 		 Baseline to 4 weeks  
FIGURE OF 8 HOP TEST  Baseline to 4 weeks  
SQUARE HOP TEST  Baseline to 4 weeks  
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   20/11/2024 
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="3"
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   This experimental study will recruit participants from soccer football club. 82 male subjects with functional ankle instability will be randomly divided into two groups. Subjects with the age group of 12 to 17 years, grade 2 ankle sprain, post injury of ankle sprain for the duration 2 to 3 months will be included for the study. Recent surgery and Recent fracture, bone tumors, Football players with grade 3 ankle sprain, Neurological conditions like cerebellar ataxia, Previous history of foot drop will be excluded. Balance Error Scoring System (BESS) and Y- balance for balance, Figure-of eight hop test & Square hop test for functional performance and surface EMG for muscle will be used as an outcome measurement. The subjects will trained for 4weeks (5days per week). After 4 weeks data will be tabulated, and statistical analysis will be done.  
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