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CTRI Number  CTRI/2019/08/020499 [Registered on: 01/08/2019] Trial Registered Prospectively
Last Modified On: 04/08/2021
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   To study the effect of exercise program in Novice archers on sport performance 
Scientific Title of Study   Comparative Analysis of Performance Variables, Performance Predictors, Shoulder Risk Factors in Elite and Novice Archers and Impact of Intervention in Novice Archers  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranita Dattatraya Ganjave  
Designation  Assistant Professor 
Affiliation  D Y Patil Deemed to be university, School of Physiotherapy 
Address  D Y Patil Deemed to be university, School of Physiotherapy ,Department of Sport Physiotherapy, 6th floor medical college building ,sector- 7 Nerul ,Navi Mumbai-400706

Thane
MAHARASHTRA
400706
India 
Phone  8779123854  
Fax    
Email  pranita.ganjave@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  DrAjit Dabholkar PhD 
Designation  Professor & HOD Department of Sport Physiotherapy 
Affiliation  D Y Patil Deemed to be university, School of Physiotherapy 
Address  D Y Patil Deemed to be university, School of Physiotherapy ,Department of Sport Physiotherapy, 6th floor medical college building ,sector- 7 Nerul ,Navi Mumbai-400706

Thane
MAHARASHTRA
400706
India 
Phone  9892502160  
Fax    
Email  ajit.dabholkar@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Pranita Dattatraya Ganjave  
Designation  Assistant Professor 
Affiliation  D Y Patil Deemed to be university, School of Physiotherapy 
Address  D Y Patil Deemed to be university, School of Physiotherapy ,Department of Sport Physiotherapy, 6th floor medical college building ,sector- 7 Nerul ,Navi Mumbai-400706

Thane
MAHARASHTRA
400706
India 
Phone  8779123854  
Fax    
Email  pranita.ganjave@dypatil.edu  
 
Source of Monetary or Material Support  
D Y Patil Deemed to be university, School of Physiotherapy ,Department of Sport Physiotherapy, 6th floor medical college building ,sector- 7 Nerul ,Navi Mumbai-400706 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pranita Ganjave  Drona Archery Academy   Drona Archery Academy Karnala Sports Academy Plot No.7,Sector 16, Behind, HOC C, Panvel, Maharashtra 410206
Thane
MAHARASHTRA 		 9664821336

pranita.ganjave@dypatil.edu 
Pranita Ganjave  Swatantraveer Savarkar Archery Academy   Swatantraveer Savarkar Archery Academy , Veer Savarakar Rashtriya Smarak, 252, SVS Rd, Dadar West, Shivaji Park, Mumbai, Maharashtra 400028
Mumbai
MAHARASHTRA 		 9664821336

pranita.ganjave@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Drona Archery Academy, Karnala Sports Academy Panvel  Approved 
Institutional Ethics Committee Padmashree Dr D Y Patil Medical college , Hospital and research Centre,Nerul Navi mumbai  Approved 
Swatantraveer Savarkar Archery Academy Dadar permission letter  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Before the recruitment ,Novice archers from various archery academies will be screened for any musculoskeletal problems, any previous history of injury , any known medical condition. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active control group  Warm up exercises -General mobility exercises for upper and lower extremity -Spot marching Upper, lower limb and back muscle flexibility exercises  
Intervention  Exercise protocol group   EXERCISE 0-3weeks Forward flexion in sidelying , Side lying shoulder external rotation at zero degree abduction, Prone horizontal abduction with External rotation, Low rows orprone extensions at zero degree ,Serratus punch 120 degree , Push up plus ,Wrist curls& Reverse wrist curls ,Grip strengthening with finger exerciser, Single leg stance firm surface -Eyes opened & Eyes closed ,Single leg multidirectional reaches Foam surface- front ,back, sideways, diagonal. EXERCISE 4-6 weeks Side planks with shoulder External rotation, Three point plank with shoulder horizontal abduction with external rotation, Three point plank with shoulder extension ,Three point plank with shoulder row, Three point plank with shoulder diagonal arm raise ,Foam roller wall slides ,Wrist Strengthening with blue and black Theraband ,Archery draw position with blue and black Theraband ,Single leg stance foam surface - Eyes opened & Eyes closed ,Single leg multidirectional reach Foam surface -front ,back, sideways, diagonal. Strengthening exercises 15 repetitions, 3 sets and Balance exercises 30sec holds, 3 sets  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1.Archers between age of 15 years to 25 years
2.Archers playing target archery
3.Novice archer - Archers playing archery for at least one year
4.Archers without any neurological problem/condition
5.Archers who are willing to participate in study
 
 
ExclusionCriteria 
Details  1.Archers below age of 15 years and above 25 years
2.Archers playing other than target archery
3.Archers playing archery for less than one year
4.Archers with any neurological problem/condition
5.Archers who are not willing to participate in study
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Target archery score   Target archery score out of 720 pre and post 6 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Postural stability by Balance error scoring system i.e BESS, Fine motor skill by Purdue peg board , Hand grip strength by Hand dynamometer and Scapular stability by Scapular dyskinesis test i.e SDT 
comparison of mentioned variables will be made pre and post 6 weeks of intervention
Total time point-6weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="49" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/08/2019 
Date of Study Completion (India) 30/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
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  

This study is a randomized, participant blinded parallel group trial aiming to find out efficacy of 6 weeks of exercise program in Novice Archers on sport performance and performance variables. The study will be conducted in three archery academies in Mumbai and Navi Mumbai. The primary outcome measure will be target archery score, scored on target face out of 720.The secondary outcomes will be postural stability measured by Balance error scoring system(BESS) (by number of errors), fine motor skill by Purdue peg board (co-ordination-number of pegs inserted),Hand grip strength by Hand dynamometer ( kg) and Scapular stability by scapular dyskinesis test (SDT). Both primary and secondary outcomes will be assessed pre intervention and post 6 weeks of intervention in both the groups.

List of sites of the study

1.Drona Archery Academy, Karnala Sports Academy Plot No.7,Sector 16, Behind, HOC C, Panvel, Maharashtra 410206
Pranita Ganjave
Phone-9664821336

 

Principal investigator

Name: Pranita Dattatraya Ganjave ,

pranita.ganjave@dypatil.edu

8779123854


 
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