Patellofemoral Pain SyndromeNCT05588050
Validity and Reliability of Two Methods for Assessing Knee Joint Position Sense
An observational study of Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The participants will be prepared for image-capture data collection by putting four squared markers, each 4 cm in diameter, will be attached to their leg at three locations while the subject in this position: (1) proximal to a quarter of the distance along a line joining the greater trochanter to the lateral knee… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- smart phone application and AutoCAD software
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to Sep 2024
- Phase
- Observational
- 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 18 to 35 years
- All sexes
- Adult
Study population: 1. Anterior or retropatellar knee pain from at least 2 of the following Activities : (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping. 2. Insidious onset of symptoms unrelated to a traumatic incident. 3. Age of the subject 18-35 years to limit the possibility that PFPS over age 35 may have been complicated by arthritic changes, and also the subjects should have closed epiphyseal growth plates. 4. Patient with chronic PFPS (pain > 3 months
Who may be able to join
- 1) Anterior or retropatellar knee pain from at least 2 of the following Activities : (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping.
- 2) Insidious onset of symptoms unrelated to a traumatic incident.
- 3) Age of the subject 18-35 years to limit the possibility that PFPS over age 35 may have been complicated by arthritic changes, and also the subjects should have closed epiphyseal growth plates.
- 4) Patient with chronic PFPS (pain > 3 months)
Who cannot join
- Meniscal or other intraarticular pathologic conditions; cruciate or collateral ligament involvement.
- A history of traumatic patellar subluxation or dislocation.
- Previous surgery in the knee, ankle and hip joints.
- Knee, ankle and hip joints osteoarthritis.
- athletes aren't included .
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of Two Methods for Assessing Knee Joint Position Sense in Patients With Patellofemoral Pain Syndrome
The participants will be prepared for image-capture data collection by putting four squared markers, each 4 cm in diameter, will be attached to their leg at three locations while the subject in this position: (1) proximal to a quarter of the distance along a line joining the greater trochanter to the lateral knee joint line, (2) over the neck of the fibula, (3) over the proximal part of the lateral malleolus. A fourth marker will be attached over the iliotibial tract adjacent to the superior border of the patella when the subject in a sitting position.
Each participant will seat on the end of an orthopedic assessment plinth and blindfolded .
Read more
Each subject will be asked to extend his/her leg and make two angles arbitrarily from the resting position (90º) to the full extension. Photos will be taken, while they keep their leg at each position for five seconds.The bubble inclinometer will be attached to the patient leg at the resting position 90 º knee flexion.
The tested leg will be passively moved by the researcher through 20° to 60° of knee extension from a starting knee angle of 90° to a target angle which will be measured by the bubble inclinometer , the participant then actively held the leg in this position for 5 second.
A photograph of the leg in the target position will be taken using the camera which will be positioned 185 cm from the subject and 65 cm from the ground The leg will then be passively returned to the starting angle, and the participant will be instructed to actively move that leg to the target angle and hold it in this position another photograph will be taken, and the participant will be instructed to move the leg back to the starting position , the process will be repeated 3 times for each target angle with rest time 5 seconds between shots.
After completing the procedure for all subjects, the test and replicated angles will be measured using the AutoCAD software and determine the center of the markers.
Also , same angles will be measured via clinometer smart phone application in those patients to assess its validityand reliability where the participant will hold the leg for five seconds for each angle where this process will be reapeated for three times for each angle.
Read the detailed description
The participants will be prepared for image-capture data collection by putting four squared markers, each 4 cm in diameter, will be attached to their leg at three locations while the subject in this position: (1) proximal to a quarter of the distance along a line joining the greater trochanter to the lateral knee joint line, (2) over the neck of the fibula, (3) over the proximal part of the lateral malleolus. A fourth marker will be attached over the iliotibial tract adjacent to the superior border of the patella when the subject in a sitting position.
Each participant will seat on the end of an orthopedic assessment plinth and blindfolded .
Each subject will be asked to extend his/her leg and make two angles arbitrarily from the resting position (90º) to the full extension. Photos will be taken, while they keep their leg at each position for five seconds.The bubble inclinometer will be attached to the patient leg at the resting position 90 º knee flexion.
The tested leg will be passively moved by the researcher through 20° to 60° of knee extension from a starting knee angle of 90° to a target angle which will be measured by the bubble inclinometer , the participant then actively held the leg in this position for 5 second.
A photograph of the leg in the target position will be taken using the camera which will be positioned 185 cm from the subject and 65 cm from the ground The leg will then be passively returned to the starting angle, and the participant will be instructed to actively move that leg to the target angle and hold it in this position another photograph will be taken, and the participant will be instructed to move the leg back to the starting position , the process will be repeated 3 times for each target angle with rest time 5 seconds between shots.
After completing the procedure for all subjects, the test and replicated angles will be measured using the AutoCAD software and determine the center of the markers.
Also , same angles will be measured via clinometer smart phone application in those patients to assess its validityand reliability where the participant will hold the leg for five seconds for each angle where this process will be reapeated for three times for each angle.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- smart phone application and AutoCAD software
- Keywords
- Patellofemoral pain syndrme
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart phone application and AutoCAD softwareDevice
to assess the validity and reliability of smart phone application and AutoCAD software in assessing knee joint position sense in patients with patellofemoral pain syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
joint position sense in patients with patellofemoral pain syndrome
joint position sense assessment in patients with patellofemoral pain syndrome
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nada magdy saad el deen, Cairo University
- Investigators
- mohamed A abdelfatah, Phd, Study director, lecturer of orthopedic at faculty of physical therapy - cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588050
- Sponsor's protocol ID
- P.T.REC/012/003957
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coelho VK, Gomes BSQ, Lopes TJA, Correa LA, Telles GF, Nogueira LAC. Knee proprioceptive function and physical performance of patients with patellofemoral pain: A matched case-control study. Knee. 2021 Dec;33:49-57. doi: 10.1016/j.knee.2021.08.031. Epub 2021 Sep 17.
PubMed 34543992
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Two Methods for Assessing Knee Joint Position Sense in Patients With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT05588050
- Acronym / sponsor ID
- P.T.REC/012/003957
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral pain syndrme
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 20 Oct 2022 (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.
The participants will be prepared for image-capture data collection by putting four squared markers, each 4 cm in diameter, will be attached to their leg at three locations while the subject in this position: (1) proximal to a quarter of the distance along a line joining the greater trochanter to the lateral knee joint line, (2) over the neck of the fibula, (3) over the proximal part of the lateral malleolus. A fourth marker will be attached over the iliotibial tract adjacent to the superior border of the patella when the subject in a sitting position.
Each participant will seat on the end of an orthopedic assessment plinth and blindfolded .
Each subject will be asked to extend his/her leg and make two angles arbitrarily from the resting position (90º) to the full extension. Photos will be taken, while they keep their leg at each position for five seconds.The bubble inclinometer will be attached to the patient leg at the resting position 90 º knee flexion.
The tested leg will be passively moved by the researcher through 20° to 60° of knee extension from a starting knee angle of 90° to a target angle which will be measured by the bubble inclinometer , the participant then actively held the leg in this position for 5 second.
A photograph of the leg in the target position will be taken using the camera which will be positioned 185 cm from the subject and 65 cm from the ground The leg will then be passively returned to the starting angle, and the participant will be instructed to actively move that leg to the target angle and hold it in this position another photograph will be taken, and the participant will be instructed to move the leg back to the starting position , the process will be repeated 3 times for each target angle with rest time 5 seconds between shots.
After completing the procedure for all subjects, the test and replicated angles will be measured using the AutoCAD software and determine the center of the markers.
Also , same angles will be measured via clinometer smart phone application in those patients to assess its validityand reliability where the participant will hold the leg for five seconds for each angle where this process will be reapeated for three times for each angle.
Detailed description
The participants will be prepared for image-capture data collection by putting four squared markers, each 4 cm in diameter, will be attached to their leg at three locations while the subject in this position: (1) proximal to a quarter of the distance along a line joining the greater trochanter to the lateral knee joint line, (2) over the neck of the fibula, (3) over the proximal part of the lateral malleolus. A fourth marker will be attached over the iliotibial tract adjacent to the superior border of the patella when the subject in a sitting position.
Each participant will seat on the end of an orthopedic assessment plinth and blindfolded .
Each subject will be asked to extend his/her leg and make two angles arbitrarily from the resting position (90º) to the full extension. Photos will be taken, while they keep their leg at each position for five seconds.The bubble inclinometer will be attached to the patient leg at the resting position 90 º knee flexion.
The tested leg will be passively moved by the researcher through 20° to 60° of knee extension from a starting knee angle of 90° to a target angle which will be measured by the bubble inclinometer , the participant then actively held the leg in this position for 5 second.
A photograph of the leg in the target position will be taken using the camera which will be positioned 185 cm from the subject and 65 cm from the ground The leg will then be passively returned to the starting angle, and the participant will be instructed to actively move that leg to the target angle and hold it in this position another photograph will be taken, and the participant will be instructed to move the leg back to the starting position , the process will be repeated 3 times for each target angle with rest time 5 seconds between shots.
After completing the procedure for all subjects, the test and replicated angles will be measured using the AutoCAD software and determine the center of the markers.
Also , same angles will be measured via clinometer smart phone application in those patients to assess its validityand reliability where the participant will hold the leg for five seconds for each angle where this process will be reapeated for three times for each angle.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Age groups
- Adult
- Study population
- 1. Anterior or retropatellar knee pain from at least 2 of the following Activities : (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping. 2. Insidious onset of symptoms unrelated to a traumatic incident. 3. Age of the subject 18-35 years to limit the possibility that PFPS over age 35 may have been complicated by arthritic changes, and also the subjects should have closed epiphyseal growth plates. 4. Patient with chronic PFPS (pain > 3 months
Key inclusion criteria (4 listed)
- 1) Anterior or retropatellar knee pain from at least 2 of the following Activities : (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping.
- 2) Insidious onset of symptoms unrelated to a traumatic incident.
- 3) Age of the subject 18-35 years to limit the possibility that PFPS over age 35 may have been complicated by arthritic changes, and also the subjects should have closed epiphyseal growth plates.
- 4) Patient with chronic PFPS (pain > 3 months)
Key exclusion criteria (6 listed)
- Meniscal or other intraarticular pathologic conditions; cruciate or collateral ligament involvement.
- A history of traumatic patellar subluxation or dislocation.
- Previous surgery in the knee, ankle and hip joints.
- Knee, ankle and hip joints osteoarthritis.
- athletes aren't included .
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 |
|---|---|---|
| smart phone application and AutoCAD softwareto assess the validity and reliability of smart phone application and AutoCAD software in assessing knee joint position sense in patients with patellofemoral pain syndrome | Device | – |
Primary outcome
joint position sense in patients with patellofemoral pain syndrome
Time frame: 2 years
joint position sense assessment in patients with patellofemoral pain syndrome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Results publication: PubMed 34543992Coelho VK, Gomes BSQ, Lopes TJA, Correa LA, Telles GF, Nogueira LAC. Knee proprioceptive function and physical performance of patients with patellofemoral pain: A matched case-control study. Knee. 2021 Dec;33:49-57. doi: 10.1016/j.knee.2021.08.031. Epub 2021 Sep 17.
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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.
mohamed A abdelfatah, Phd study director
lecturer of orthopedic at faculty of physical therapy - cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Oct 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada m saad eldeen, MSc (+201225816871 ext. 002, nada_assar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
joint position sense in patients with patellofemoral pain syndrome (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05588050, which also lists 1 linked publication.
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 21 Oct 2022.