- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465380
Stabilization vs Corrective Exercise in PFP
Functional Stabilization Training VS Comprehensive Corrective Exercises on Lower Limb Kinematics in Patellofemoral Pain and Dynamic Knee Valgus
Study Overview
Status
Conditions
Detailed Description
PF pain impairs performance and quality of life and can predispose individuals to early PF osteoarthritis and Dynamic knee valgus has been identified as a modifiable risk factor for PF pain and serious knee injury .
Current rehabilitation strategies show mixed results. Solo hip strengthening programs may not correct Dynamic knee valgus. While both Functional Stabilization training (FST) and comprehensive corrective programs (CCEP) show potential benefits, direct comparisons are lacking. The FST suggested superior outcomes with functional training, but it did not specifically target DKV. Conversely, the CCEP demonstrated kinematic improvements, but included asymptomatic participants and lacked patient reported outcomes.
By directly comparing Functional Stabilization training (FST) with the CCEP, this study aims to provide clinicians with evidence based guidance on the most effective exercise strategy for improving lower limb kinematics and reducing pain. The findings could inform best practice guidelines and enhance outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Alshab, PhD Cand
- Phone Number: +201008816911
- Email: ahmed.s.alshabb@gmail.com
Study Contact Backup
- Name: Enas Fawzy, PhD
- Email: enas.fawzy@pt.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patellofemoral pain lasting > 6 weeks
- Demonstrates dynamic knee valgus during single-leg squat (FPPA ≥ 10°).
- Arabic Kujala Patellofemoral Scale (KPS) score < 80.
- Age 18-35 years
Exclusion Criteria:
- Previous knee surgery; ligament/meniscus injury; or lower-limb fractures
- Neurologic disorders.
- Systemic inflammatory disease
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Care (SC)
Standard care exercise program for patellofemoral pain.
Participants receive 24 supervised sessions (3 sessions/week for 8 weeks), ~45-60 minutes/session."
(If you want 1 extra line: "Exercises follow a conventional PFP program based on Baldon et al.")
|
Supervised standard care exercise therapy for patellofemoral pain, delivered 3 sessions/week for 8 weeks (24 sessions), ~45-60 minutes/session.
|
|
Experimental: Functional Stabilization Training (FST)
Functional stabilization/neuromuscular training to optimize movement patterns and dynamic alignment.
24 supervised sessions (3/week for 8 weeks), ~45-60 minutes/session.
Includes warm-up/cool-down (~15 min) and ~45 min exercises.
Intensity/progression increases every 2 weeks; exercises progress from ~2 sets (10-20 reps) with ~5-sec isometric holds to ~3 sets of ~12 reps with ~10-sec holds and added external load (weights/elastic resistance)
|
Supervised functional stabilization/neuromuscular exercise program focusing on lower-limb alignment and movement control.
3 sessions/week for 8 weeks (24 sessions), ~45-60 minutes/session, progressive difficulty/load
Other Names:
|
|
Experimental: Comprehensive Corrective Exercise Program (CCEP)
Comprehensive corrective exercise program targeting strength, flexibility, neuromuscular control, and alignment across the kinetic chain for dynamic knee valgus.
24 supervised sessions (3/week for 8 weeks), ~45-60 minutes/session.
Three phases: weeks 1-2 sensorimotor/non-weight-bearing alignment + feedback + isometrics; weeks 3-6 progressive weight-bearing with increased load/complexity and emphasis on co-contraction/reciprocal activation; weeks 7-8 functional tasks to maintain gains and challenge multi-planar control.
Visual/verbal/tactile feedback provided; progression only with correct technique
|
Supervised comprehensive corrective exercise program targeting flexibility, strength, and neuromuscular control across the kinetic chain to address dynamic knee valgus.
3 sessions/week for 8 weeks (24 sessions), ~45-60 minutes/session, phase-based progression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak Knee Abduction (Valgus) Angle (3D motion analysis)
Time Frame: Baseline and 8 weeks
|
Change in peak knee abduction (valgus) angle of the stance limb measured using a 3D motion capture system (Vicon) during functional tasks (single-leg squat and drop/vertical jump landing).
Lower values indicate reduced dynamic knee valgus.
|
Baseline and 8 weeks
|
|
Hip and Pelvis Kinematics (3D motion analysis)
Time Frame: Baseline and 8 weeks
|
Change in peak hip adduction, peak hip internal rotation, contralateral pelvic drop, and trunk lateral lean during the functional tasks measured by 3D motion capture.
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kujala Patellofemoral Scale (KPS)
Time Frame: Baseline and 8 weeks
|
Change in patient-reported knee function using the Arabic Kujala Patellofemoral Scale (0-100)
|
Baseline and 8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Sahabuddin, F. N. A., Jamaludin, N. I., Amir, N. H., & Shaharudin, S. (2021). The effects of hip- and ankle-focused exercise intervention on dynamic knee valgus: a systematic review. PeerJ, 9, e11731. https://doi.org/10.7717/peerj.11731
- Rabelo, N. D. D. A., Costa, L. O. P., Lima, B. M., Dos Reis, A. C., Bley, A. S., Fukuda, T. Y., & Lucareli, P. R. G. (2017). Adding motor control training to muscle strengthening did not substantially improve the effects on clinical or kinematic outcomes in women with patellofemoral pain: A randomised controlled trial. Gait & posture, 58, 280-286. https://doi.org/10.1016/j.gaitpost.2017.08.018
- Emamvirdi, M., Letafatkar, A., & Khaleghi Tazji, M. (2019). The Effect of Valgus Control Instruction Exercises on Pain, Strength, and Functionality in Active Females With Patellofemoral Pain Syndrome. Sports health, 11(3), 223-237. https://doi.org/10.1177/1941738119837622
- Baldon, R. D. M., Serrão, F. V., Silva, R. S., & Piva, S. R. (2014). Effects of functional stabilization training on pain, function, and lower extremity biomechanics in women with patellofemoral pain: A randomized clinical trial. Journal of Orthopaedic & Sports Physical Therapy, 44(4), 240-251. https://doi.org/10.2519/jospt.2014.4940
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FSTvsCCEP in PFP and DKV
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.
Clinical Trials on Patellofemoral Pain Syndrome
-
University of North Carolina, Chapel HillCanadian Institutes of Health Research (CIHR)CompletedPatellofemoral Pain Syndrome | Patellofemoral Pain (PFPS) | Patellofemoral Pain | Patellofemoral Pain, PFPUnited States
-
Lauren EricksonAmerican College of Sports MedicineCompleted
-
Beijing Sport UniversityCompletedPatellofemoral PainChina
-
Boston Children's HospitalEnrolling by invitationPatellofemoral PainUnited States
-
Istanbul University - CerrahpasaRecruitingPatellofemoral Pain, PFPTurkey (Türkiye)
-
Beijing Sport UniversityNot yet recruitingPatellofemoral Pain, PFP
-
Beijing Sport UniversityNot yet recruiting
-
Pamukkale UniversityNot yet recruitingPatellofemoral Pain, PFPTurkey (Türkiye)
-
Ahram Canadian UniversityNot yet recruitingPatellofemoral Pain (PFPS)Egypt
-
Beijing Sport UniversityCompletedPatellofemoral Pain, PFPChina
Clinical Trials on Standard Care Exercise Program (SC)
-
University of Colorado, DenverCompleted
-
Hospital San Carlos, MadridUnknown
-
Universidade do PortoFundação para a Ciência e a Tecnologia; Centro Hospitalar De São João, E.P.E.UnknownObesity | Metabolic Bone Disease | Accidental FallsPortugal
-
Federal University of Health Science of Porto AlegreIrmandade Santa Casa de Misericórdia de Porto AlegreUnknownGynecologic Cancer | Pathological ConstrictionBrazil
-
Chulalongkorn UniversityCompleted
-
University of AberdeenNHS GrampianCompletedTakotsubo CardiomyopathyUnited Kingdom
-
Aydin Adnan Menderes UniversityCompletedLabor Duration | Labor Bain | and Birth Satisfaction During Physiologic Vaginal BirthTurkey (Türkiye)
-
University of PittsburghCompletedArthroplasty, Replacement, KneeUnited States
-
University of ChicagoCompletedObesity | Type 2 DiabetesUnited States
-
The University of Hong KongNot yet recruiting