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CTRI Number  CTRI/2021/03/032447 [Registered on: 31/03/2021] Trial Registered Prospectively
Last Modified On: 29/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association of knee movement, seat height and cycling performance  
Scientific Title of Study   Relationship among knee range of motion, saddle height and performance of elite cyclists 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  LANKIPALLI NIRANJAN 
Designation  Post Graduate Student 
Affiliation  Manipal Academy of Higher Eduacation 
Address  Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore Bangalore KARNATAKA 560017 India Bangalore KARNATAKA 560017 India
98, Rustam Bagh, Old Airport Road,
Bangalore
KARNATAKA
560017
India 
Phone  09052222687  
Fax    
Email  lankipalliniranjan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Karvannan H  
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore Bangalore KARNATAKA 560017 India Bangalore KARNATAKA 560017 India
98, Rustam Bagh, Old Airport Road,
Bangalore
KARNATAKA
560017
India 
Phone  9986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr V Prem 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore Bangalore KARNATAKA 560017 India Bangalore KARNATAKA 560017 India
98, Rustam Bagh, Old Airport Road,
Bangalore
KARNATAKA
560017
India 
Phone  9886647732  
Fax    
Email  prem.v@manipal.edu  
 
Source of Monetary or Material Support  
No 98, Rustam Bagh, Old Airport road, Department of physiotherapy, School of allied health sciences, Manipal Academy Of Higher Education, Bangalore- 560017 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education  
Address  Department of physiotherapy, School of allied health sciences, MAHE, Manipal 576104 
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 
Lankipalli Niranjan  Manipal Hospital  Upper Basement, Department of Physiotherapy, Manipal Hospital, #98 Rustam bagh Layout , old airport road, Bangalore, KARNATAKA 560017
Bangalore
KARNATAKA 		 9052222687

lankipalliniranjan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Elite cyclists 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Elite level cyclists will be included
Both the male and female cyclists will be included
 
 
ExclusionCriteria 
Details  Recent fractures in upper and lower limbs will be excluded
Cyclists with any overuse injuries related to cycling in the past 12 months will be excluded
Individuals with neurological (peripheral nerve lesions) or musculoskeletal (recent ligament tears) conditions will be excluded
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Critical power test  Immediate observation only at Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Knee ROM  Immediate observation only at baseline 
Saddle height using inseam length  Immediate observation only at baseline 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   05/04/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Suspended 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Need of the study

Previous studies identified the relationship between the performance and various factors like crank length, physiological and psychological factors which can influence the performance of the cyclist. However there is paucity of studies focusing on relationship of knee range of motion, saddle height and performance.

Aim of the study

The aim of the current study is to find the relationship among knee range of motion, saddle height and performance of elite cyclists.

cycling performance can’t be evaluated by single factor, so in depth study on interrelation of performance with different variables had became obligatory.

Total of three saddle heights will be assessed, of which two saddle heights will be based on the knee angle i.e., 250 and 350 with crank at  bottom dead center irrespective of the anthropometric measures and third saddle height at 109% inseam is applied. After assessing how the performance, saddle height are related, knee range of motion will be assessed.

 
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