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CTRI Number  CTRI/2025/01/079646 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 26/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Lateral Trunk Lean walking in 7 days, on Knee Pain and Function in Individuals Having Degenerative Knee Pain.  
Scientific Title of Study   Added Short Term Effect of Lateral Trunk Lean Gait on Pain of Knee Joint and Physical Function in Patients with Osteoarthritis of Knee- An Experimental Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kunal balasaheb bhujbal 
Designation  MPT 
Affiliation  MAEERS Physiotherapy College Talegaon Dabhade 
Address  MAEERS physiotherapy college near railway station 2nd floor Musculoskeletal physiotherapy department cabin number A-207 talegaon dabhade, pune.

Pune
MAHARASHTRA
410507
India 
Phone  7775932298  
Fax    
Email  kunalbhujbal0@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Snehal Ghodey 
Designation  Principal 
Affiliation  MAEERS physiotherapy college Talegaon dabhade 
Address  MAEERS physiotherapy college near railway station 2nd floor Musculoskeletal physiotherapy department cabin number A-207 talegaon dabhade, pune.

Pune
MAHARASHTRA
410507
India 
Phone  9422326959  
Fax    
Email  gsnehavi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Snehal Ghodey 
Designation  Principal 
Affiliation  MAEERS physiotherapy college Talegaon dabhade 
Address  MAEERS physiotherapy college near railway station 2nd floor Musculoskeletal physiotherapy department cabin number A-207 talegaon dabhade, pune.

Pune
MAHARASHTRA
410507
India 
Phone  9422326959  
Fax    
Email  gsnehavi@gmail.com  
 
Source of Monetary or Material Support  
MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Cabin number A 207 talegaon dabhade, Pune India, 410507 
 
Primary Sponsor  
Name  MAEERS Physiotherapy College 
Address  MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Cabin number A 207 talegaon dabhade, Pune India, 410507 
Type of Sponsor  Private medical college 
 
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 Snehal Ghodey  MAEERS physiotherapy college talegaon dabhade pune  MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department cabin number A-207 Talegaon Dabhade, Pune India 410507.
Pune
MAHARASHTRA 
9422326959

gsnehavi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAEERSphysiotherapy college ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  convectional physiotherapy treatment  Muscle strengthening exercises to knee flexors, knee extensors, and hip abductors will be given with 60% to 80% of 1 repetition maximum (1RM) and 50% to 60% of 1 RM for people not accustomed to strength training, 2 to 4 sets of 8 to 15 repetitions with 30- to 60-second breaks between sets. Muscle stretching to the hamstring, gastrocnemius, and quadricep if required Manual stretching 30-second hold 3 times. 
Intervention  lateral trunk lean gait  In lateral trunk lean gait, the patient leans laterally from the spine on the side where the knee is more painful compared to the contralateral knee. this training will be given to the patient using visual and audible feedback in front of mirror. After getting trained patient will do lateral lean with heel strike on the more pain full limb and will be erect with flat foot phase of gait. This reduces medial compartment contact force. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Clinically diagnosed cases of knee osteoarthritis.
Clinical diagnosing ACR criteria
The American College of Rheumatology lists six clinical criteria, three of which must be met, in addition to pain in the knee. 
 
ExclusionCriteria 
Details  Patients with a waddling gait.
Recent soft tissue injuries of the lower limb.
Patient with lower limb fracture.
Patients with spine conditions.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain (visual analog scale)  pre and post-intervention 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
time up and go test  pre and post-intervention 1 week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/02/2025 
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  

Osteoarthritis is a chronic degenerative disorder in which there is a loss of articular cartilage, bone hypertrophy, subdural sclerosis synovial membrane, and joint capsule involvement. In the late stages of OA ulceration softening and focal degeneration of articular cartilage are seen.

During normal ambulation in healthy knees, the medial compartment experiences 60%-80% of the weight-bearing load. This much load is present on degenerative cartilage in osteoarthritis.

These alterations cause biomechanical alterations like increased internal tibiofemoral rotation and peak knee adduction moment (KAM) contribute to the onset and progression of osteoarthritis.

Lateral trunk lean gait is a modification for OA knee patients to reduce knee adduction moment on the knee joint and reduce contact force on the medial compartment.

This study will be done to check whether the lateral trunk lean gait modification has a short-term effect on the pain of the knee joint and physical function in patients with knee osteoarthritis.

Patients with clinically diagnosed knee osteoarthritis using clinical diagnosing ACR criteria will be included. Consent will be taken from all the patients.

Patients will be assessed using the TUG test for knee function, the pain will be assessed using the VAS scale after including them in the study based on inclusion criteria. Then the patient will be assigned to one of the groups, the intervention group or control group by using the lottery method.

In the control group, convectional physiotherapy treatment will be given.

In the experimental group along with conventional physiotherapy treatment, the patient will be doing trunk lateral lean gait modification while walking for 7 days.

Trunk lateral lean gait is defined as a walking pattern characterized by a noticeable tilt or shift of the upper body to one side during the stance phase of gait. This lateral lean typically involves a deviation of the trunk away from the midline of the body.

For this patient will be trained. The patient will be standing in front of a mirror.

Then, the patient will be asked to lean lateral through the torso by 100. 100 lateral lean will be measured with a universal goniometer.

The patient will be trained to lean 100 with visual, verbal, and tactile biofeedback.

This training will be included in the gait pattern. The patient will be asked to “At heel strike, lean sideways with the torso towards the foot on the most affected leg and return back slowly during stance phase.”

After completing the intervention for 7 days patient pain will be assessed using the VAS scale and knee function will be assessed using the TUG test. The scores will be recorded and the pre- and post-intervention scores will be analyzed statistically to get the result.

 
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