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CTRI Number  CTRI/2024/06/069404 [Registered on: 24/06/2024] Trial Registered Prospectively
Last Modified On: 10/05/2024
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   In our study we will be including who are having lumbopelvic hip complex dysfunction. We will be giving corrective exercise continuum to see the effect on throwing velocity and upper extremity performance  
Scientific Title of Study   Effectiveness of corrective exercise continuum on throwing velocity and upper extremity performance in cricket bowlers with Lumbopelvic hip complex dysfunction: A Randomized controlled trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhanashree Satish Maral 
Designation  Postgraduate Student 
Affiliation  MGM Institute of Physiotherapy  
Address  Department of Sports Physiotherapy, no.3, MGM Institute Of Physiotherapy, N-6,CIDCO,Aurangabad

Aurangabad
MAHARASHTRA
431003
India 
Phone  7498788679  
Fax    
Email  dhanashreemaral@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarath Babu 
Designation  Professor 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Sports Physiotherapy, no.3, MGM Institute Of Physiotherapy, N-6,CIDCO,Aurangabad

Aurangabad
MAHARASHTRA
431003
India 
Phone  9545079173  
Fax    
Email  sharathcrisp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dhanashree Satish Maral 
Designation  Postgraduate Student 
Affiliation  MGM Institute of Physiotherapy  
Address  Department of Sports Physiotherapy, no.3, MGM Institute Of Physiotherapy, N-6,CIDCO,Aurangabad

Aurangabad
MAHARASHTRA
431003
India 
Phone  7498788679  
Fax    
Email  dhanashreemaral@gmail.com  
 
Source of Monetary or Material Support  
Department of Sports Physiotherapy, no.3, MGM Institute of Physiotherapy ,N-6,CIDCO,Aurangabad 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy 
Address  N-6,CIDCO, Aurangabad, Maharashtra 431003, India 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Dhanashree Maral  MGM Institute of Physiotherapy  Sports Physiotherapy Department, C Building, MGM, N-6,CIDCO,Aurangabad
Aurangabad
MAHARASHTRA 		 7498788679

dhanashreemaral@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM IOP Institutional Ethics Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cricket Bowlers With lumbopelvic Hip complex dysfunction 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Corrective exercise continuum  After randomization, participants in this particular group will be provided with corrective exercises aimed at addressing excessive forward lean and low back arch during their training sessions. The corrective exercise regimen comprises of four techniques. The first technique involves inhibit exercises, which include self myofascial release. The second technique is lengthen exercises, which consist of static stretching and are to be performed for a duration of 1-2 weeks. The third technique is activation exercises, which involve isolated strengthening exercises and should be carried out for a period of 3-5 weeks. Lastly, the fourth technique is integrate exercises, which encompass integrated dynamic movement and are to be performed for a duration of 6-8 weeks. The total duration : 8 weeks 
Comparator Agent  Regular fitness training  This group will perform regular fitness training . Total duration : 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Male 
Details  1.Age between 18-24 years
2.Sex- Male cricket bowlers(fast and medium)
3.Individual practicing more than 1 year at least 3 days/week
4. LPHC dysfunction -Overhead squat assessment(OHSA)
(Excessive forward lean and Low back arch)  
 
ExclusionCriteria 
Details  1.History of any musculoskeletal injury or surgery in last 6 months
2.Excessive forward lean and low back arch due to LLD on modified squat test
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Throwing velocity using Radar gun (Bushnell Speedster ɪɪɪ)  Pre and post intervention period (8 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
Upper extremity performance using Medicine Ball Throw Test (MBTT) and Throwing accuracy test  Pre and post intervention period (8 weeks) 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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   Phase 2 
Date of First Enrollment (India)   01/07/2024 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dhanashreemaral@gmail.com].

  6. For how long will this data be available start date provided 01-07-2024 and end date provided 01-07-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized, single blinded ,two arm parallel group trial. The consult forms will be taken for participating in the study and for photographic assessment. Male cricket bowlers aged between 18-24 years be selected for screening process. For including the participants in the study overhead squat assessment will be performed and photography will be taken by therapist and analyzed using Kinovea software (for excessive forward lean and Low back arch) For confirming the findings participants will asked to performed modified squat test . After screening the participants are allocated into 2 group i.e. experimental and control group .The experimental group will receive corrective exercises to address excessive forward lean and low back arch along with regular fitness training for 8 weeks and control group will carry out regular fitness training .Outcome measures will be assessed pre and post intervention for throwing velocity and upper extremity performance. Statistical analysis of the collected data will be done. Conclusion will be established based on the obtained results of the study. 
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