- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07531550
Core and Hip-Knee Exercises in PFPS (DKV)
EFFECT OF CORE STABILITY EXERCISES AND KNEE, HIP FOCUSED EXERSISES ON DYNAMIC KNEE VALGUS IN PATELLOFEMORAL PAIN SYNDROME
Study Purpose:
The purpose of this study is to investigate the effect of adding core muscle strengthening exercises to a hip- and knee-focused exercise program on pain intensity, dynamic knee valgus (DKV), and functional outcomes in female patients with patellofemoral pain syndrome (PFPS).
Research Question:
Does adding core muscle strengthening exercises to a hip- and knee-focused exercise program have an effect on pain intensity, dynamic knee valgus (DKV), and functional outcomes in female patients with PFPS?
Study Overview
Status
Intervention / Treatment
Detailed Description
Detailed Description:
Therefore, the current study aims to investigate the effect of adding core muscle strengthening exercises to a hip- and knee-focused exercise program on pain intensity, dynamic knee valgus (DKV), and functional outcomes in female patients with patellofemoral pain syndrome (PFPS).
The findings of this study may provide a more effective rehabilitation program for female patients with PFPS, support the use of validated outcome measures in clinical practice, and improve symptom management during activities of daily living and functional recovery within a shorter period of time. This combined approach may be more efficient than the conventional hip- and knee-focused exercise program alone. Systematic assessment and monitoring of patient outcomes are recommended to guide clinical decision-making.
Study Delimitations:
This study will be delimited to:
Female patients clinically diagnosed with patellofemoral pain syndrome (PFPS). Thirty-six participants aged 19-35 years with body mass index (BMI) up to 25 kg/m².
Assessment procedures including Visual Analogue Scale (VAS) for knee pain, dynamic knee valgus (DKV) measured using Kinovea software, and the Knee Outcome Survey-Activities of Daily Living Scale (KOS-ADLS) for knee function.
Treatment procedures:
Group A (control group): hip- and knee-focused exercise program. Group B (study group): hip- and knee-focused exercise program in addition to core muscle stability exercises.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Radwa M Hussien, PT, PhD
- Phone Number: +201004411584
- Email: radwabelal94@gmail.com
Study Contact Backup
- Name: Dina S Abdallah, PT, PhD, Lecturer
- Phone Number: +201282742057d
- Email: drdinasayed_pt@yahoo.com
Study Locations
-
-
Giza Governorate
-
Giza, Giza Governorate, Egypt, 12613
- Cairo University - Faculty of Physical Therapy
-
Contact:
- Radwa M Hussien, PT,PhD
- Phone Number: +201004411584
- Email: radwabelal94@gmail.com
-
Contact:
- Dina S Abdallah, PT, PhD, Lecturer
- Phone Number: +201282742057
- Email: drdinasayed_pt@yahoo.com
-
Principal Investigator:
- Radwa M Hussien, Pt, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Thirty-six female participants diagnosed and referred with patellofemoral pain syndrome (PFPS) (retropatellar knee pain lasting more than 6 weeks).
- Age range between 19-35 years.
- Body Mass Index (BMI) up to 25 kg/m².
Exclusion Criteria:
- History of previous surgeries of the lower limb.
- Clinical evidence of knee joint complex disorders, including meniscus lesions, 3-patellar tendinopathy, chondral lesions, or knee osteoarthritis.
4-Presence of pronated foot.
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 |
|---|---|
|
Active Comparator: control group hip and knee focused exercises program
Open kinetic chain exercises including side-lying hip abduction, hip external rotation (clamshell), prone hip extension, short arc quadriceps, and straight leg raises
|
Open kinetic chain exercises including side-lying hip abduction, hip external rotation (clamshell), prone hip extension, short arc quadriceps, and straight leg raises (Khayambashi et al., 2012) ( Dolak et al., 2011).
|
|
Experimental: Study group hip and knee focused exercises program in addition to core muscle training exercises
participants who will received the same exercise program as control group, in addition to core muscle training exercises, including the front plank, side plank, and dead bug exercises
|
core muscle training exercises, including the front plank, side plank, and dead bug exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity During Motion
Time Frame: Baseline (pre-intervention) and at 6 weeks (post-intervention)
|
Pain intensity during movement will be assessed using the Visual Analog Scale (VAS).
The VAS is a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
|
Baseline (pre-intervention) and at 6 weeks (post-intervention)
|
|
Knee Function
Time Frame: Baseline (pre-intervention) and at 6 weeks (post-intervention)
|
Knee function will be assessed using the Knee Outcome Survey (KOS).
The KOS score ranges from 0 to 100, where higher scores indicate better knee function.
|
Baseline (pre-intervention) and at 6 weeks (post-intervention)
|
|
Pain Intensity at Rest
Time Frame: Baseline (pre-intervention) and at 6 weeks (post-intervention)
|
Pain intensity at rest will be assessed using the Visual Analog Scale (VAS).
The VAS is a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
|
Baseline (pre-intervention) and at 6 weeks (post-intervention)
|
|
Dynamic Knee Valgus (DKV)
Time Frame: Baseline (pre-intervention) and at 6 weeks (post-intervention)
|
Dynamic knee valgus will be assessed by measuring the knee valgus angle in degrees during functional tasks.
Higher values indicate greater valgus deviation and poorer knee alignment.
|
Baseline (pre-intervention) and at 6 weeks (post-intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Radwa M Hussien, Pt, PhD, Cairo University - Faculty of Physical Therapy
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
- P.T. REC/012/006181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
There is no plan to share individual participant data (IPD) from this study. All collected data will remain confidential and will not be made publicly available in order to protect participant privacy and comply with ethical regulations.
Access Criteria:
Not applicable, as individual participant data will not be shared.
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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