- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07703072
Effect of Short Foot Exercise Combined With Focused Hip and Knee Exercises on Pain, Q Angle and Functional Outcomes in Female Patients With Patellofemoral Pain Syndrome
Study Overview
Status
Conditions
Detailed Description
Patellofemoral Pain Syndrome (PFPS) is a common musculoskeletal condition characterized by anterior knee pain, particularly prevalent among females due to anatomical and biomechanical factors. Although conventional rehabilitation focuses on hip and quadriceps strengthening, persistent symptoms suggest the involvement of distal biomechanical contributors such as foot pronation and intrinsic foot muscle weakness.
Short Foot Exercise (SFE) targets intrinsic foot musculature, improves medial longitudinal arch stability, and enhances neuromuscular control. This study investigates whether combining SFE with hip and knee strengthening provides superior outcomes compared to conventional rehabilitation alone.
This study is a two-arm parallel randomized controlled trial including 38 female participants aged 18-45 years diagnosed with PFPS. Participants will be randomly allocated into experimental and control groups using a computer-generated sequence with allocation concealment. The intervention will be conducted over 6 weeks, with three supervised sessions per week.
The experimental group will receive short foot exercises along with hip and knee strengthening, while the control group will receive hip and knee strengthening only. Outcome measures including pain (VAS), functional status (Kujala AKPS), and Q-angle will be assessed at baseline and post-intervention.
The study aims to determine whether a combined proximal-distal rehabilitation approach leads to better improvements in pain, alignment, and functional outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Afifa Khizar, MSPT
- Phone Number: +923359077922
- Email: afifa.khizar15@gmail.com
Study Contact Backup
- Name: Aroona Sattar
- Phone Number: +923054630138
- Email: aroona.sattar@ubas.edu.pk
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- NUR FMH System
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Contact:
- Muhammad Shahzad, MSPT
- Phone Number: +923028350237
- Email: muhammad.shahzad.qadree@niu.edu.pk
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Contact:
- Hira Nadeem, MSPT
- Phone Number: +923094229283
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Diagnosed cases of patellofemoral pain syndrome confirmed by this protocol.
- Females aged 18-45 years
- Anterior or retro patellar knee pain lasting ≥ 6 weeks
Pain provoked by at least one PFJ-loading task, including:
- squatting,
- stair climbing/descending,
- running,
- prolonged sitting with knees flexed
Pain elicited by at least two of four clinical tests;
- Pain during isometric quadriceps contraction at 20-30° knee flexion
- Pain on palpation of the patellofemoral joint line
- Pain during patellar compression
- Pain during active resisted knee extension
Exclusion Criteria:
History of patellar instability, including subluxation or dislocation 2. Evidence of tibiofemoral pathology, such as: Ligamentous injuries, meniscal tears, and symptomatic knee effusion.
3. Previous knee surgery within the last 12 months 4. Radiographic or clinical knee osteoarthritis. 5. Neurological disorders or systemic inflammatory diseases that may influence gait or pain perception.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: (Short Foot + Hip and Knee Exercises)
Participants in this group will receive a combined rehabilitation program consisting of short foot exercises (SFE) along with focused hip and knee strengthening exercises.
The intervention aims to address both distal (foot) and proximal (hip and knee) biomechanical factors contributing to patellofemoral pain syndrome.
The program will be supervised, conducted three times per week for 6 weeks, with progressive advancement from non-weight-bearing to functional weight-bearing activities.
|
Short Foot Exercises (SFE) Structured intrinsic foot muscle training involving medial longitudinal arch elevation without toe flexion, progressing from seated to standing and functional positions. Hip and Knee Strengthening Exercises Progressive strengthening program targeting hip abductors, external rotators, and quadriceps muscles through functional and resistance-based exercises. |
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Active Comparator: (Hip and Knee Exercises Only)
Participants in this group will receive a conventional rehabilitation program consisting of focused hip and knee strengthening exercises only.
This program targets proximal muscle groups responsible for patellofemoral joint stability and function.
The intervention will be supervised, conducted three times per week for 6 weeks, and matched in duration and intensity to the experimental group.
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Hip and Knee Strengthening Exercises alone Progressive strengthening program focusing on hip abductors, external rotators, and quadriceps muscles, including both non-weight-bearing and functional weight-bearing exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kujala Anterior knee pain scale (AKPS)
Time Frame: Baseline measurement and after 6 weeks intervention
|
The Kujala AKPS is a 13-item questionnaire specifically designed to evaluate symptoms and functional limitations associated with patellofemoral disorders.
It assesses domains such as limping, walking, running, stair climbing, squatting, sitting, swelling, and pain.
Total scores range from 0 to 100.
Scores ranging 90-100 indicating better knee function while score range from 0-50 shows significant pain and functional impairment.
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Baseline measurement and after 6 weeks intervention
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Visual Analogue Scale
Time Frame: Baseline measurement and after 6 weeks intervention
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The Visual Analogue Scale is a 10-cm line used to assess the intensity of pain.
Participants mark a point on the line that represents their current level of pain, ranging from 0 = no pain to 10 = worst possible pain.
The distance in centimeters is measured to quantify pain severity.
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Baseline measurement and after 6 weeks intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Q angle
Time Frame: Baseline measurement and after 6 weeks intervention
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The Q-angle represents the quadriceps pull angle, measured using a universal goniometer by aligning landmarks at the anterior superior iliac spine (ASIS), center of patella, and tibial tuberosity.
Patient lies in a supine relaxed position with knee extended.
Fulcrum of goniometer is placed directly over the center of patella and stationary arm is aligned with the line connecting ASIS to midpoint of patella while the moving arm is aligned with the line connecting tibial tuberosity to the midpoint of patella.
It provides insight into lower-limb alignment and patellar tracking mechanics.
Normal Q angle measurement in females ranges from 13-19 degrees.
Altered or increased Q-angles have been associated with PFPS and patellar maltracking.
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Baseline measurement and after 6 weeks intervention
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Collaborators and Investigators
Investigators
- Study Chair: Shoaib Waqas, PHD PT, Lahore University of Biological and Applied Sciences
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBAS/ERB/26/04/032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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