| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mountain trekkers |
|
|
Intervention / Comparator Agent
|
|
|
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 . |