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CTRI Number  CTRI/2020/01/022926 [Registered on: 23/01/2020] Trial Registered Prospectively
Last Modified On: 22/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Balance training on Ankle stability in Wrestlers to improve performance 
Scientific Title of Study   Effectiveness of 6 weeks balance training on balance and disabilities in Wrestling 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  Jyoti Aggarwal 
Designation  Post-graduate Student 
Affiliation  Guru Jambheshwar University of Science and Technology 
Address  Dept. of Physiotherapy, Guru Jambheshwar University of Science and Technology, NH-10, New Delhi-Rohtak-Sirsa National Highway

Hisar
HARYANA
125001
India 
Phone  9711926133  
Fax    
Email  jyotiaggarwal875@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kulandaivelan S 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology 
Address  Assistant Professor, Dept of Physiotherapy, Guru Jambheshwar University of Science and Technology, NH-10,New Delhi-Rohtak-Sirsa Highway,

Hisar
HARYANA
125001
India 
Phone  09996003995  
Fax    
Email  tryhard2024@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Kulandaivelan S 
Designation  Assistant Professor 
Affiliation  Guru Jambheshwar University of Science and Technology 
Address  Assistant Professor, Dept of Physiotherapy, Guru Jambheshwar University of Science and Technology, NH-10,New Delhi-Rohtak-Sirsa Highway,

Hisar
HARYANA
125001
India 
Phone  09996003995  
Fax    
Email  tryhard2024@yahoo.co.in  
 
Source of Monetary or Material Support  
Jyoti Aggarwal, MPT (Sports), Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar-125001. 
 
Primary Sponsor  
Name  Self Student 
Address  Dept. of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar-125001. 
Type of Sponsor  Other [Student herself] 
 
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 
Jyoti Aggarwal  Wrestling hall  Ground Floor, Sports Authority of India, Giri Center, Haryana Agriculture University, Hisar-125001.
Hisar
HARYANA 		 9711926133

jyotiaggarwal875@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active control group  Normal Physiotherapy interventions Strengthening exercises Standing balances Duration 6 weeks 
Intervention  Balance training  progressive balance training as per Hale et al., 2007 Frequency 5 days per week Duration 6 week Stages 3 (Progression at every second week) 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  1. History of at least 1 substantial ankle sprain or balance impairment .
2. Multiple episodes of the ankle ‘‘giving way,’’ recurrent sprain, and ‘‘feelings of instability’’ in the 6 months before the study.
3. If both ankles will be having CAI, the ankle with the highest score (ie, the most severely affected ankle) will be considered as the involved limb.
 
 
ExclusionCriteria 
Details  1. Volunteers will be excluded if they have sustain an acute lower extremity injury in the last 6 months .
2. Not taken any formal rehabilitation in the last 6 months .
3. History of lower extremity surgery or fracture that required alignment in the involved limb.
4. Any diagnosed neurologic dysfunction, such as multiple sclerosis, Parkinson disease, or head injury.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Star Excursion Balance Test
Foot and Ankle ability measures of ADLs and Sports 		 0 week (pre)
6th week (post) 
 
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)   27/01/2020 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Ankle sprain is very common in wrestling. Wrestlers started to play active games once pain goes off and/or strength gained. They and coaches gives little emphasis to proprioceptive training or balance training. This leads to ankle instability which is very common in wrestling. Players with ankle instability find difficult to stand on one leg and reach on one leg excetra. Ankle instability may impair the performance hence it is important to measure it and properly rehabilitate it. The objective of this trial is to see the 6 week balance training on balance and disability. 
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