| 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
|
|
|
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
|
|
|
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.â€
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. |