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CTRI Number  CTRI/2025/01/079514 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
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 Knee Alignment Exercises vs. Standard Treatment on Pain, Strength, and Mobility in People with Knee Pain 
Scientific Title of Study   Effect of valgus control instruction exercises versus conventional treatment on pain, strength and function in patients with patellofemoral pain syndrome -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  Rasika Sawarkar 
Designation  MPT 
Affiliation  MAEERS Physiotherapy College Talegaon Dabhade  
Address  MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department Cabin no A 207 Talegaon Dabhade

Pune
MAHARASHTRA
410507
India 
Phone  09422326959  
Fax    
Email  rasikaps24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Snehal Ghodey  
Designation  Professor  
Affiliation  MAEERS Physiotherapy College Talegaon Dabhade  
Address  MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department Cabin no A 207 Talegaon Dabhade

Pune
MAHARASHTRA
Dr Snehal Ghodey
India 
Phone  09422326959  
Fax    
Email  gsnehavi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Snehal Ghodey  
Designation  Professor  
Affiliation  MAEERS Physiotherapy College Talegaon Dabhade  
Address  MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department Cabin no A 207 Talegaon Dabhade

Pune
MAHARASHTRA
Dr Snehal Ghodey
India 
Phone  09422326959  
Fax    
Email  gsnehavi@gmail.com  
 
Source of Monetary or Material Support  
MAEERS Physiotherapy College Talegaon Dabhade MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department Cabin no A 207 Talegaon Dabhade Pune India 410507  
 
Primary Sponsor  
Name  MAEERs Physiotherapy College 
Address  MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department Cabin no 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   MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Department Cabin no 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 
MAEERS College of Physiotherapy ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional tretament  The conventional protocol given will be stretching of hamstrings, iliotibial band, hip flexors and calf muscles 30 sec hold 3 repetitions each, strengthening of quadriceps, hip abductors and external rotators and core muscles by calculating 10 repetition maximum and balance training which includes tandem walking, narrow base of support with eyes open and then closed and single leg standing. 
Intervention  Valgus control instruction exercises  Valgus control instruction exercises are a set of exercises formulated to manage patients with patellofemoral pain syndrome. Is is a set of 16 exercises. The duration of exercises is 6 weeks. These exercises mainly focus on the alignment of the knee while performing exercises. Internal focus instructions like keep the knee over toe, land with flexed knee and external focus like try to land on the floor markers are used to draw patients attention. External Focus instructions employ unconscious or instinctive processes to more efficiently support motor learning. VCI exercises can correct knee valgus angle through reeducation of motor controls. Exercises performed in first week are Squat in front of mirror 0°-60° of knee flexion 10 repetitions with 5 sec hold 2 sets of 10 repetitions with 5 second hold, Squat 0°-60° of knee flexion 2 sets of 20 repetitions with 5 sec hold, Lateral walk with elastic resistance around the forefoot 2 sets of 20 repetitions with 5 sec hold. Exercises performed in 2nd week are Pelvic drop while standing 3 sets of 12 repetitions, Squat with elastic resistance 0°-60° of knee flexion 3 sets of 12 repetitions with 10 second hold, Squat on BOSU ball 2 sets of 20 repetitions 5 sec hold, Forward lunge in front of mirror 3 sets of 12 repetitions, Forward lunge, Balance exercise on BOSU Ball 3 sets of 20 seconds, Exercises performed in 3rd week are Single-leg balance at 30° of knee flexion 3 sets of 12 repetitions, Squat with elastic resistance around the knees 3 sets of 12 repetitions, Unipedal squat on BOSU ball 3 sets of 12 repetitions, Modified forward lunge with elastic around the knee 3 sets of 12 repetitions, Romanian deadlift 3 sets of 12 repetitions, Lateral sliding without jumping 3 sets of 12 repetitions, Hip lateral rotation 3 sets of 12 repetitions.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Anterior knee pain patients diagnosed by Orthopedic
The clinical practice guideline for PFPS by The American Physical Therapy Association diagnostic criteria:
Presence of retro patellar or peripatellar pain
Reproduction of retro patellar or peripatellar pain during squatting, or other functional activities loading the PFJ in a flexed position
 
 
ExclusionCriteria 
Details  Previous surgery in lower limb
Any other diagnosed knee and hip conditions
Patellar instability/ subluxation
Low back pain referring pain to knee
 
 
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 analogue scale), strength (hand held dynamometer)  pre and post intervention 6 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
function (anterior knee pain scale)  pre and post intervention 6 weeks 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   01/02/2025 
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  

Patellofemoral pain syndrome (PFPS) is a prevalent knee condition characterized by pain around or behind the patella, typically worsened by activities like squatting, running, or stair climbing that place stress on the knee. It affects a broad range of people, especially young, active individuals and athletes, with a higher prevalence in females due to factors such as greater quadriceps angle (Q angle) and dynamic valgus. PFPS is often caused by a misalignment in patellar tracking during knee movement, with biomechanical issues like weak lower extremity muscles, tightness in structures around the knee, and foot overpronation contributing to the condition.

Recent studies explore the impact of valgus control instruction (VCI) exercises, which aim to correct knee valgus by re-educating motor control. Exercise instructions can be categorized into internal focus (IF), which directs attention to body movements, and external focus (EF), which focuses on movement outcomes. EF instructions are thought to better facilitate motor learning by encouraging instinctive responses. VCI exercises show promise in improving knee alignment, particularly in comparison to conventional treatments, offering a potential benefit in managing PFPS.

A visual analog scale will be used to evaluate anterior knee pain in participants who meet the inclusion criteria. A dynamometer will be used to measure quadriceps, hip abductors, and external rotators strength, and an anterior knee pain scale will be used to evaluate function. Using the simple random sampling technique, the participants who meet the inclusion requirements will be divided into two groups. For six weeks, one group will receive traditional treatment three times a week, while the other group will receive exercises involving valgus control teaching three times a week.

All the three outcomes will be assessed after 6 weeks of intervention. Data will be collected and analyzed 
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