Total Knee ArthroplastyNCT07233005
The Effect of Quadriceps Sets Exercise on Knee Joint Biomechanics and Functional Outcomes of Post-Total Knee Arthroplasty Patients
A study testing Quadriceps Set Exercise, Terminal Knee Extension and Traditional Physical Therapy in people with Total Knee Arthroplasty, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Quadriceps Set Exercise, Terminal Knee Extension and Traditional Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Cognitive impairment.
- Neuromuscular impairment.
- Patient can't walk alone (need of assistive device).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Quadriceps Set Exercise, Terminal Knee Extension, Traditional Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadriceps Set ExerciseProcedure or surgery
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 ExtensionProcedure or surgery
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 TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Quadriceps Set & Terminal Knee Extension Exercises Group (Study Group) | Experimental | Not described Receives: Procedure: Quadriceps Set Exercise; Procedure: Terminal Knee Extension; Procedure: Traditional Physical Therapy |
| Traditional Physical Therapy Group (Control Group) | Experimental | Not described Receives: Procedure: Traditional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analoge Scale (VAS)
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.
Measured: Four weeks
Quadriceps Muscle Strength
it will be measured using a hand held dynamometer.
Measured: 4 weeks
Secondary outcomes (3)
Range of Motion (ROM)
ROM of last ten degree of knee extension measured by goniometer
Measured: 4 weeks
Oxford Knee Score (OKS)
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.
Measured: 4 weeks
The Western Ontario and McMaster Universities Osteoarthritis Index (The WOMAC)
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
- = mild
- = moderate
- = severe
- = extreme Total score ranges from: 0 = best possible (no symptoms). 96 = worst possible (severe symptoms).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Dec 2025
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rokaia Ali Zainelabedeen Mohamed Toson, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233005
- Sponsor's protocol ID
- 10-03-46
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Quadriceps Sets Exercise on Knee Joint Biomechanics and Functional Outcomes of Post-Total Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT07233005
- Acronym / sponsor ID
- 10-03-46
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadriceps Set & Terminal Knee Extension Exercises Group (Study Group) | Experimental | Procedure: Quadriceps Set Exercise, Procedure: Terminal Knee Extension, Procedure: Traditional Physical Therapy |
| Traditional Physical Therapy Group (Control Group) | Experimental | Procedure: Traditional Physical Therapy |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Cognitive impairment.
- Neuromuscular impairment.
- Patient can't walk alone (need of assistive device).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadriceps Set ExerciseQuadriceps 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. | Procedure or surgery | Quadriceps Set & Terminal Knee Extension Exercises Group (Study Group) |
| Terminal Knee ExtensionTerminal 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. | Procedure or surgery | Quadriceps Set & Terminal Knee Extension Exercises Group (Study Group) |
| Traditional Physical TherapyTraditional 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. | Procedure or surgery | Quadriceps Set & Terminal Knee Extension Exercises Group (Study Group), Traditional Physical Therapy Group (Control Group) |
Primary outcome
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.
Quadriceps Muscle Strength
Time frame: 4 weeks
it will be measured using a hand held dynamometer.
3 secondary outcomes
Range of Motion (ROM)
Time frame: 4 weeks
Oxford Knee Score (OKS)
Time frame: 4 weeks
The Western Ontario and McMaster Universities Osteoarthritis Index (The WOMAC)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadriceps Set Exercise, Terminal Knee Extension and Traditional Physical Therapy in people with Total Knee Arthroplasty, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analoge Scale (VAS) (time frame: Four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.