| CTRI Number |
CTRI/2026/01/100040 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| 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 Hip and Knee Exercises with Balance Training on Pain, Balance, and Daily Function in People with Knee Cap Pain |
|
Scientific Title of Study
|
Effect of Hip and Knee Strengthening and Proprioceptive Training on Pain, Balance and Functional Outcome in Patients with Patellofemoral Pain Syndrome. A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjali Ambre |
| Designation |
PG Student |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College Of Physiotherapy, Third Floor, Department of Musculoskeletal Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14,Near Raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9082776097 |
| Fax |
|
| Email |
sanjaliambre456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Rathod |
| Designation |
Associate Professor |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College Of Physiotherapy, Third Floor, Department of Musculoskeletal Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14,Near Raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9082390287 |
| Fax |
|
| Email |
dr.deepali.pankaj.rathod@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Rathod |
| Designation |
Associate Professor |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College Of Physiotherapy, Third Floor, Department of Musculoskeletal Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14,Near Raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9082390287 |
| Fax |
|
| Email |
dr.deepali.pankaj.rathod@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs Lokmanya Tilak College Of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College Of Physiotherapy, Third Floor, Department of Musculoskeletal Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14,Near Raghunath Vihar, Kharghar, Navi Mumbai, Maharashtra |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College Of Physiotherapy, Third Floor, Department of Musculoskeletal Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14,Near Raghunath Vihar, Kharghar, Navi Mumbai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjali Ambre |
TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College Of Physiotherapy, Third Floor, Department of Musculoskeletal Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14,Near Raghunath Vihar, Kharghar, Navi Mumbai , Maharashtra
Raigarh
MAHARASHTRA |
9082390287
sanjaliambre456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs Lokmanya Tilak College of Physiotherapy Institutional ethics committee (Academics) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M222||Patellofemoral disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hip and Knee Strengthening Exercises Combined with Proprioceptive Training and standard care |
The training intensity was set at 70% of each individuals one-repetition maximum, which was defined as the heaviest load a person could manage for a single repetition without experiencing pain. This maximum capacity was determined during the initial session and reassessed on a weekly basis to make any necessary modifications.
Clamshells (Hip External Rotation)- Side-lying, knees bent, open top knee against resistance band 2–3 sets × 15 reps
Side-lying Hip Abduction- Lift top leg straight upward, toes slightly pointed down 2–3 sets × 12–15 reps
Prone Hip Extension- Lift leg straight up while lying on stomach 2 sets × 15 reps
Standing Hip Abduction (Resistance Band)- Lift leg sideways while standing upright 2 sets × 12–15 reps
Glute Bridges (with Band Around Knees)- Supine position, lift pelvis, engage glutes 2–3 sets × 12 reps
Straight Leg Raises (SLR)- Supine, lift leg with knee straight 2–3 sets × 12–15 reps
Terminal Knee Extensions (TKE- Extend knee against a resistance band 2 sets × 12 reps
Mini Squats (0–45°)- Standing, feet shoulder-width apart, slow descent 2-3 sets × 10 reps
Wall Sits (Isometric Hold)- Back against wall, knees flexed 30–45 Hold for 30–60 sec × 3 reps
Proprioceptive exercises
Weeks 1–2 Proprioceptive Training on Stable Surface
Weeks 3–4 on Unstable Surface
Dosage and Duration
Frequency: 3 sessions per week
Session duration: 30–45 minutes
Total intervention period:4 weeks
All exercises will be supervised initially and progressed as per patient tolerance. |
| Comparator Agent |
Standard care for Patellofemoral Pain Syndrome |
Duration: 4 weeks
Frequency: 3 sessions per week
Session Duration: 15 – 20 minutes
Patient Education, Counselling and Ergonomic advice-
Participants will be provided with basic knowledge about:
The nature and causes of PFPS, including malalignment, overuse, muscular imbalance, and patellar mal tracking.
Postural awareness and ergonomic advice for reducing joint stress.
Importance of avoiding activities that exacerbate symptoms (e.g., deep squatting, stair climbing, running).
Guidance on pacing activities, the importance of consistent exercise, and adherence to therapy.
Postural and Ergonomic advice is given which included-
Sitting: Use of cushions under thighs to reduce knee pressure, limit prolonged sitting with knees flexed 90°.
Stair Use: Minimized; if necessary, ascend one step at a time, leading with the unaffected leg.
Work Activities: If participant is employed in a job requiring squatting or kneeling, modification strategies will be discussed.
Participants will be informed that:
The pain is not due to structural damage but can improve with gradual exercise.
Compliance with the exercise program is crucial to recovery.
Stretching and Flexibility Exercises-
Performed under supervision with gentle guidance to avoid strain. Each stretch is held for 30 seconds and repeated 3 times
Quadriceps - Standing quad stretch
Hamstrings- Supine or seated stretch
Calf (Gastrocnemius and Soleus)- Wall stretch with one foot behind and heel down
Iliotibial Band (ITB)- Cross-leg standing lean or side-leaning stretch against a wall
Cryotherapy
Ice pack applied to the anterior knee for 10 minutes post-session if:
Participant reports post-exercise soreness
Signs of inflammation or swelling. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Pain intensity 3 to 7 on vas score
Peri and retropatellar non traumatic pain
Pain to reproduce at least 2 task in squatting kneeling prolonged sitting stair ascending and descending hopping and running.
Positive patellar tilt test |
|
| ExclusionCriteria |
| Details |
History of recurrent patellar subluxation or dislocation, History of surgery to the knee joint
Patients with recent lower limb fractures or dislocations
Signs, symptoms, or radiological findings of intra-articular pathologies, such as effusion, ligamentous or meniscal involvement, were excluded from the study.
Those with referred pain from the hip, back, or sacroiliac joint, acute knee strain or sprain
Degenerative and infectious arthritis were also excluded.
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain- Numerical pain rating scale (NPRS)
Balance –Star excursion balance test
Functional outcome-Kujala Anterior Knee Pain Scale
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
22/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomised control trial to study the effect of hip and knee strengthening and proprioceptive training on Pain, Balance and Functional outcome in Patients with Patellofemoral Pain Syndrome.This study included 62 patients diagnosed with patello femoral pain syndrome with in the age group of 18 to 45 years. The outcome measures used are Numerical pain rating scale (NPRS) ,Balance –Star excursion balance test,Kujala Anterior Knee Pain Scale.Although strengthening and proprioceptive training have shown individual benefits, there is a critical lack of well- designed studies investigating their combined effect, particularly in diverse population. Existing research is often limited to small sample size, lack of control groups and narrow participants demographics. Most current studies focus on one intervention at a time, making it difficult to assess the potential synergistic effects of combining strengthening exercises with proprioceptive training, which could lead to more holistic and effective treatment approaches for PFPS. Unlike previous studies that may have focused on a homogeneous sample, this research will include participants from diverse backgrounds in terms of age, gender, and severity of symptoms, ensuring that the results are applicable to a broader and more representative PFPS population.
|