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CTRI Number  CTRI/2025/03/083000 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 14/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Link between lower back strength and balance on movement in mountain trekkers 
Scientific Title of Study   Correlation Between Lumbar Core Muscle Strength and Dynamic Balance in Mountain Trekkers 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya Pradeep Khichkar 
Designation  PG Student 
Affiliation  Maeers physiotherapy college Talegaon Dabhade 
Address  Maeers physiotherapy college near railway station 2nd floor muscloskeletal physiotherapy Department Cabin no A 207 Talegaon dabhade

Pune
MAHARASHTRA
410507
India 
Phone  9309510872  
Fax    
Email  khichkarpriya05@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neetu Mahapatra 
Designation  Professor 
Affiliation  maeers physiotherapy college Talegaon dabhade  
Address  Maeers physiotherapy college near railway station 2nd floor muscloskeletal physiotherapy Department Cabin no A 221 Talegaon dabhade

Pune
MAHARASHTRA
410507
India 
Phone  9823236752  
Fax    
Email  neetu@mitmimer.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neetu Mahapatra 
Designation  Professor 
Affiliation  maeers physiotherapy college Talegaon dabhade  
Address  Maeers physiotherapy college near railway station 2nd floor muscloskeletal physiotherapy Department Cabin no A 221 Talegaon dabhade

Pune
MAHARASHTRA
410507
India 
Phone  9823236752  
Fax    
Email  neetu@mitmimer.com  
 
Source of Monetary or Material Support  
MAEERs Physiotherapy college Talegaon Dabhade , MAHARASHTRA, 410507 , India  
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable  
Type of Sponsor  Other [] 
 
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 Neetu Mahapatra   MAEERS Physiotherapy College   MAEERS Physiotherapy College 2nd floor musculoskeletal Physiotherapy Department Cabin no A 207
Pune
MAHARASHTRA 
9823236752

neetu@mitmimer.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maeers colleg of physiotherapy Ethics commiteee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Mountain trekkers 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Individual who is actively engage in mountain trekking have experienced traversing diverse mountain terrains, ascending to high elevation, and walking with heavy backpacks
2.Mountain trekkers with all the grades of difficulty level
 
 
ExclusionCriteria 
Details  1. Individuals with Muscloskeletal injury .
2 . Individuals with neurological,vestibular or balance disorders .
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation between lumbar core muscle strength and dynamic balance in mountain trekkers   pre assessment  
 
Secondary Outcome  
Outcome  TimePoints 
1. lumbar core muscle strength by using pressure biofeedback unit
2. dynamic balance by using
Y balance test  
Pre assessment  
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   25/03/2025 
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 Yet Recruiting 
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  

Mountain trekking involves extended periods of low intensity exercises ranging from a single day hike up multi day or even week expeditions .  It has found to be beneficial for cardiovascular and muscle fitness . However the risk of fall which second most common cause of mountain trekking injuries counteracts these benefits .  Participants have navigate uneven terrain , ascend and descend hills and mountains and maintain balance on rough paths , these changing elevation and irregular surfaces demands strong dynamic balance skills to avoid musculoskeletal injuries. Participants need a strong core to maintain balance while transitioning between dynamic and static states and carrying a heavy backpack. Core muscle activation occurs before limb movement, providing proximal stability and a solid foundation for the limbs to engage and mobilize effectively. Walking long distances with external loads places increased strain on the spine and lower limb joints, often leading to musculoskeletal injuries such as stress fractures, joint sprains, shin splints, and muscle strains. Those with weak core strength are likely to adopt poor posture, further compromising balance and stability. Insufficient core strength often results in overuse of the lower back and hip muscles, which can lead to early fatigue and a higher risk of injury.  Aim of these study is to find out correlation between lumbar core muscle strength and dynamic balance in mountain trekkers. 62 participants , Mountain trekkers will selected on the basis of inclusion and exclusion criteria . There lumbar core strength will be assessed by pressure biofeedback unit and dynamic balance will be assessed by Y balance test .  Correlation  between  lumbar core muscle strength and dynamic balance will be measured by using Pearson correlation coefficient .

 
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