| CTRI Number |
CTRI/2025/09/094458 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exercises for hip knee and foot to reduce knee pain and improve balance in people with patellofemoral pain |
|
Scientific Title of Study
|
Effectiveness Of Short Foot Exercises along With Hip and Knee Muscle Strengthening on pain Dynamic balance and functional status in Patellofemoral Pain Syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parth Daga |
| Designation |
Under Graduate Student |
| Affiliation |
Pravara Institute of Medical Science |
| Address |
Pravara Institute of Medical Sciences Dr APJ Abdul Kalam College of Physiotherapy department of sports physiotherapy room no 405 Tal:Rahata Dist:Ahmednagar 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9637630875 |
| Fax |
|
| Email |
dagaparth18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Borkar |
| Designation |
HOD Sports Department |
| Affiliation |
Pravara Institute of Medical Science |
| Address |
Pravara Institute of Medical Sciences Dr APJ Abdul Kalam College of Physiotherapy department of sports physiotherapy room no 405 Tal:Rahata Dist:Ahmednagar 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9168572881 |
| Fax |
|
| Email |
pnb2609@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Borkar |
| Designation |
HOD Sports Department |
| Affiliation |
Pravara Institute of Medical Science |
| Address |
Pravara Institute of Medical Sciences Dr APJ Abdul Kalam College of Physiotherapy department of sports physiotherapy room no 405 Tal:Rahata Dist:Ahmednagar 413736
MAHARASHTRA
413736
India |
| Phone |
9168572881 |
| Fax |
|
| Email |
pnb2609@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pravara Institute of Medical Sciences Dr APJ Abdul Kalam College of Physiotherapy department of sports physiotherapy room no 405 Tal:Rahata Dist:Ahmednagar 413736 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Parth Daga |
Dr APJ Abdul Kalam College of Physiotherapy PIMS DU |
Pravara Institute of Medical Sciences Dr APJ Abdul Kalam College of Physiotherapy department of sports physiotherapy room no 405 Tal:Rahata Dist:Ahmednagar 413736
Ahmadnagar
MAHARASHTRA |
9637630875
dagaparth18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicalCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M705||Other bursitis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Controlled Group |
Cryotherapy8mins
Ultrasound 5to8mins
Static quads and hams
SLR in 3 planes
Quads and Hams stretch
|
| Intervention |
Short Foot Exercises |
Exercise program for 1to3 weeks
1.Short foot exercises
A. Short Foot Walking
Walk barefoot or in socks keeping the short foot activation.
Perform for 1to2 minutes repeat 2to3 times.
B. Single Leg Balance with Short Foot
Stand on one foot while maintaining the arch lift.
Hold for 30to60 seconds repeat 2to3 sets per foot.
C. Spread toes apart then lift them while keeping the arch engaged.
Hold for 5 seconds repeat 10 reps 23 sets
2.Knee quadriceps and hamstring muscle strengthening
A. walking lunge 5reps and 3sets
B. single leg dips 5reps and 3sets
C. plyometric exercises with resistance band 5reps and 3 sets
D. Quads and Hams stretch
3.Hip abductor and adductor muscle strengthening
A. single leg squats 5reps and 3sets
B. Bulgarian split squat 5reps and 3sets
C. Hip thrusts 5reps and 3sets
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Visual analog score rating of pain minimum of 3 to6.
2. Pain in the anterior knee associated with at least 3 of the
following
a. During or after activity
b. Prolonged sitting
c. Stair ascent or descent
d. Squatting
3. Insidious onset of symptoms unrelated to trauma and persistent for at least 4 week
4.Pain elicited at least three of the following four tests
a. Isometric muscle contraction with slightly bent knee
b. Palpation of patellofemoral line
c. Active resisted knee
d. Patellar compression against the femoral bone
5.Participnats with kujala patellofemoral scoring system score 50 or less than 50
|
|
| ExclusionCriteria |
| Details |
1.Any soft tissue injury
2. Positive patellar apprehension sign
3. Osgood-Schlatter or Sinding Larsen Johansson syndrome
4. Evidence of effusion
5. Hip or lumbar referred pain
6.Any History of recurrent patellar subluxation or dislocation
7.Any History of surgery of lower limb affecting the knee joint
8. Any medications
9. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Visual Analog Scale validity:0.60 to 0.90 and reliability 0.71 to 0.99
2. The Kujala Patellofemoral Scoring System validity:0.63 to 0.92 and reliability 0.79 to 0.98
3. MFT Balance Analyzer validity:0.62 to 0.89 & reliability 0.70 to 0.95
|
Week 0 and Week 6
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/09/2025 |
| 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 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
|
Protocol is prepared and ethical clearance will be obtained from the IEC. The Participants will be selected based on the eligibility criteria. Informed consent will be obtained from the participants and demographic data will be recorded. Participants will be randomly allocated to 2 groups that is experimental group n15 and control group n15. Prior assessment of the participants will be done. Experimental group will be administered with the Short Foot Exercises along With Hip and Knee Muscle Strengthening with normal daily training protocol and control group receive daily training program. INTERVATION GROUP PROTOCOL Exercise program for 1to3 weeks 1.Short foot exercises A. Short Foot Walking Walk barefoot or in socks keeping the short foot activation. Perform for 1to2 minutes repeat 2to3 times. B. Single Leg Balance with Short Foot Stand on one foot while maintaining the arch lift. Hold for 30to60 seconds repeat 2to3 sets per foot. C. Spread toes apart then lift them while keeping the arch engaged. Hold for 5 seconds repeat 10 reps 23 sets 2.Knee quadriceps and hamstring muscle strengthening A. walking lunge 5reps and 3sets B. single leg dips 5reps and 3sets C. plyometric exercises with resistance band 5reps and 3 sets D. Quads and Hams stretch 3.Hip abductor and adductor muscle strengthening A. single leg squats 5reps and 3sets B. Bulgarian split squat 5reps and 3sets C. Hip thrusts 5reps and 3sets CONTROLLED GROUP PROTOCOL Cryotherapy8mins Ultrasound 5to8mins Static quads and hams SLR in 3 planes Quads and Hams stretch All the instructions will be given verbally provided demonstration and guided through a single practice trial of SFE. The participants will be given exercise regimen and administered to perform for 20to25 mins per day for 4 days in a week for 6 weeks. The Dynamic balance is measured with MFT Balance Analyzer, The pain is measured with Visual Analog Scale and functional status is measured with The Kujala Patellofemoral Scoring System Statistical analysis will be done and result will be calculated |