- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07233005
The Effect of Quadriceps Sets Exercise on Knee Joint Biomechanics and Functional Outcomes of Post-Total Knee Arthroplasty Patients
March 7, 2026 updated by: Rokaia Ali Zainelabedeen Mohamed Toson, Cairo University
Lower limb strengthening, especially the quadriceps training, is of much necessity for patients with knee arthroplasty.
As the quadriceps strengthening exercises play a vital role in controlling gait pattern during walking and different activities.
Vastus inetrmedius muscle responsible for the last 10 degree of knee extension.
This enable the knee joint to be in locked position which is the stable position during gait.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sakakah, Saudi Arabia
- Jouf University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age (ranging from 40 to 60 years old).
- Weight (ranging from 65 to 75 kg).
- Height (ranging from 150 to 165 cm)
- Sex ( male/ female).
- Patients who undergoing total knee arthroplasty after 1 months until one year after operation.
Exclusion Criteria:
- Cognitive impairment.
- Neuromuscular impairment.
- Patient can't walk alone (need of assistive device).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: Quadriceps Set & Terminal Knee Extension Exercises Group (Study Group)
|
Quadriceps knee set exercises was introduced with the patient in sitting position and pillow was placed under his knee joint then ask patient to dorsiflex his ankle and extend knee make hold 10 second then relax.
Two exercises session per week for four week.
Terminal knee extension exercise using Thera band was introduced with the patient in sitting or standing position and the theraband was placed around his knee joint.
Two exercises session per week for four week.
Traditional physical therapy program will include passive stretching exercise to the hamstrings while the patient is supine lying flex the hip while the knee extended and hold for 30-45 seconds, strengthening exercise to the guadriceps muscle by extending the knee whie the patient is in the sitting position.
|
|
Experimental: Traditional Physical Therapy Group (Control Group)
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Traditional physical therapy program will include passive stretching exercise to the hamstrings while the patient is supine lying flex the hip while the knee extended and hold for 30-45 seconds, strengthening exercise to the guadriceps muscle by extending the knee whie the patient is in the sitting position.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analoge Scale (VAS)
Time Frame: Four weeks
|
VAS is a straight horizontal line of usually 100 mm.
The ends are defined as the extreme limits of the pain .
It is orientated from the left (worst) to the right (least) pain.
|
Four weeks
|
|
Quadriceps Muscle Strength
Time Frame: 4 weeks
|
it will be measured using a hand held dynamometer.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion (ROM)
Time Frame: 4 weeks
|
ROM of last ten degree of knee extension measured by goniometer
|
4 weeks
|
|
Oxford Knee Score (OKS)
Time Frame: 4 weeks
|
The OKS is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks.The Oxford Knee Score (OKS) ranges from 0 to 48, 0 = Worst possible knee pain/function.
48 = Best possible knee pain/function.
|
4 weeks
|
|
The Western Ontario and McMaster Universities Osteoarthritis Index (The WOMAC)
Time Frame: 4 weeks
|
It is a questionnaire of 24-item. Self-administered tool used to assess pain, stiffness, and physical function in patients with hip and knee osteoarthritis. WOMAC Likert Version (0-96 total) Each item scored: 0 = none
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2025
Primary Completion (Actual)
February 1, 2026
Study Completion (Actual)
March 1, 2026
Study Registration Dates
First Submitted
November 14, 2025
First Submitted That Met QC Criteria
November 14, 2025
First Posted (Actual)
November 18, 2025
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 7, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 10-03-46
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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National Taiwan Normal UniversityCompletedEating Behavior | Food RewardTaiwan