FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/074751 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 04/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [different load intervention , unilaterally and bilaterally at metronomical speed 85 BPM. ]  
Study Design  Other 
Public Title of Study   A study to investigate Biomechanical and Physiological responses of walking pattern among health adults while carrying Loads in hand held unilaterally and bilaterally.  
Scientific Title of Study   Biomechanical and Physiological Responses of Gait While Carrying Hand-Held Unilateral or Bilateral Load among Healthy Adults . 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anilendu Pramanik  
Designation  Assistant Professor 
Affiliation  MYAS-GNDU Department of Sports Sciences and Medicine, Guru Nanak Dev University  
Address  MYAS-GNDU Department of Sports Sciences and Medicine, Guru Nanak Dev University, G.T. road Amritsar, Punjab India Amritsar PUNJAB 143005 India

Amritsar
PUNJAB
143005
India 
Phone  8527886622  
Fax    
Email  anilendu.myas@gndu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Anilendu Pramanik  
Designation  Assistant Professor 
Affiliation  MYAS-GNDU Department of Sports Sciences and Medicine, Guru Nanak Dev University  
Address  MYAS-GNDU Department of Sports Sciences and Medicine, Guru Nanak Dev University, G.T. road Amritsar, Punjab India Amritsar PUNJAB 143005 India

Amritsar
PUNJAB
143005
India 
Phone  8527886622  
Fax    
Email  anilendu.myas@gndu.ac.in  
 
Details of Contact Person
Public Query  
Name  Mayank Bindoriya 
Designation  Post Grad Student 
Affiliation  MYAS- GNDU, Department of Sports Sciences and Medicine, Guru Nanak Dev University  
Address  Sports Biomechanics Research Lab, MYAS-GNDU Department of Sports Sciences and Medicine, Guru Nanak Dev University, G.T. road Amritsar, Punjab India

Amritsar
PUNJAB
143005
India 
Phone  7503446300  
Fax    
Email  bindoriyamayank26@gmail.com  
 
Source of Monetary or Material Support  
MYAS-GNDU Department of Sports Sciences and Medicine, Guru Nanak Dev University, Amritsar Punjab - 143001 , India 
 
Primary Sponsor  
Name  Ministry of Youth Affairs and Sports Govt of India 
Address  Shastri Bhavan, New Delhi- 110001, India 
Type of Sponsor  Government funding agency 
 
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 Anilendu Pramanik  Guru Nanak Dev University  Sports Biomechanics Lab,MYAS-GNDU Department of Sports Sciences and Medicine , Guru Nanak Dev University, G.T. road, Amritsar Amritsar PUNJAB
Amritsar
PUNJAB 		 8527886622

anilendu.myas@gndu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Guru Nanak Dev University, Amritsar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adults participants within age group between 18-25 years. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No Load (NL)  No Load (NL) comprised of 0kg, that means subject will be walking with hands-free loading conditions. 
Intervention  Very Light Weight(VLW) Light Weight(LW) Moderate Weight(MW)  Very Light weight (VLW) comprised of 5kg, Light Weight(LW) comprised of 7.5kg, Moderate Weight(MW) comprised of 10kg. Each intervention will be applied on participants for 3 minutes duration in which participants will get accustomed with the intervention and the gait data will be collected at the last minute of the intervention. A 1.5 minutes of rest paused will be provided to each participants after each intervention to ensure the baseline resting condition before start of the next intervention. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Individual healthy adults with moderate physical activity level.
2. Individual with age of range between 18-25 yrs.
3. Individuals should have hand-held load carriage experiences 
 
ExclusionCriteria 
Details  1. Individual with any medical condition
2. Individual having beyond the age range category i.e., before 18 and more than 25 of age
3. Individual with assistive Devices (Who use crutches ,walkers and orthopedic braces )
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Gait parameters (spatial parameters and kinematic parameters), physiological variables like heart rate, body temp, energy expenditure etc.  Baseline (i.e., first 30 sec of data recording)
Mid-Cycle (i.e., 30 sec between middle of 1st & 2nd minute)
Final-Cycle (i.e., last 30 sec of data recording) 
 
Secondary Outcome  
Outcome  TimePoints 
Perceptual variables like RPE (Rating of perceived exertion) & videographic few biomechanical parameters will be done.  Baseline (i.e., first 30 sec of data recording)
Mid-Cycle (i.e., 30 sec between middle of 1st & 2nd minute)
Final-Cycle (i.e., last 30 sec of data recording) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   15/10/2024 
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)   Open to Recruitment 
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   The current study will evaluate the biomechanical and physiological responses of unilateral and bilateral hand-held moderate intensity load carriage among healthy adults. From the data we could postulate the maximum weight bearing capacity and hence it will  provide a general safety measures in the society. 
Close