Patellofemoral Pain SyndromeNCT03685812
Validity and Reliability of Autocad Software Assessment of JPS in PFPS
An observational study of Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The overall aim of the study is to assess the reliability and validity of Autocad software to measure JPS in PFPS, especially: 1. To assess the intra-tester and between day reliability of measurement of JPS using Autocad software. 2. To assess the validity of these measurements against those found during an IKD. 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?
- Autocad software
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2018to 1 Feb 2019
- 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
- No healthy volunteers
- Adult
Study population: thirty-eight patients(males and females) with PFPS will be recruited from the outpatient clinic of the faculties of Physical Therapy, Cairo University, Egypt.
Who may be able to join
- 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; (6) hopping/jumping; (7) kneel sitting
- Insidious onset of symptoms unrelated to a traumatic incident.
- 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.
- 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 weren't included.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of Autocad Software Assessment of Joint Position Sense in Patellofemoral Pain Syndrome
The overall aim of the study is to assess the reliability and validity of Autocad software to measure JPS in PFPS, especially:
- To assess the intra-tester and between day reliability of measurement of JPS using Autocad software.
- To assess the validity of these measurements against those found during an IKD.
Read the detailed description
Patellofemoral pain syndrome (PFPS) is a common painful musculoskeletal condition that affects physically active young adults and adolescents.
Joint position sense (JPS) is considered as a component of proprioception as it provides the clinician with information regarding the accuracy of movement as well as its relationship with movement performance and injuries. Therefore researchers use advanced instruments as 3 D video systems and isokinetic dynamometer. Since these instruments are less portable and expensive, therefore researchers used another method to evaluate JPS using high precision software using video analysis and markers in the joints. Unfortunately, video analysis requires difficult and time-consuming tasks and that this slow the evaluation process.
Although immediate feedback could help physiotherapists and athletic trainers to monitor athletes and make decisions during the training session and the rehabilitation process, such immediacy is not available for proprioceptive tests in field situations. Autocad software is available and inexpensive and provides immediate feedback
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Autocad software
- Keywords
- Patellofemoral Pain Syndrome, Autocad software, position sense, validity, reliability
- 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.
Autocad softwareDiagnostic test
Also called Isokinetic system
The participants will be prepared for image-capture data collection by putting four squared markers on leg and thigh.Each subject will extend his/her leg and make two angles from the resting position (90º) to the full extension, photos will be taken. The tested leg passively moved by the researcher through 20° to 60° of knee extension, 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. The angles will be measured using the AutoCAD software. Knee JPS measurements will also be collected using an IKD by same steps
| Study group | Role | What they receive |
|---|---|---|
| patients with patellofemoral pain syndrome , Auto Cad software | Patients referred with a confirmed diagnosis of patellofemoral pain syndrome, with a visual analogue scale of more than 3. 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. Receives: Diagnostic Test: Autocad software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concurrent validity of Autocad software
correlation between absolute angular error of Autocad software and isokinetic system
Measured: one day
Secondary outcomes (1)
Intrarater reliability of
same investigator will repeat joint positsion sense by Autocad software
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start25 Sep 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karima Abdelaty Hassan, Cairo University
- Investigators
- karima A Hassan, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685812
- Sponsor's protocol ID
- patellofemoral pain syndrome
- Status last verified
- Mar 2019
- First submitted
- 24 Sep 2018
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akseki D, Akkaya G, Erduran M, Pinar H. [Proprioception of the knee joint in patellofemoral pain syndrome]. Acta Orthop Traumatol Turc. 2008 Nov-Dec;42(5):316-21. doi: 10.3944/aott.2008.316. Turkish.
PubMed 19158451Baker V, Bennell K, Stillman B, Cowan S, Crossley K. Abnormal knee joint position sense in individuals with patellofemoral pain syndrome. J Orthop Res. 2002 Mar;20(2):208-14. doi: 10.1016/S0736-0266(01)00106-1.
PubMed 11918299Drouin JM, Valovich-mcLeod TC, Shultz SJ, Gansneder BM, Perrin DH. Reliability and validity of the Biodex system 3 pro isokinetic dynamometer velocity, torque and position measurements. Eur J Appl Physiol. 2004 Jan;91(1):22-9. doi: 10.1007/s00421-003-0933-0. Epub 2003 Sep 24.
PubMed 14508689Relph N, Herrington L. Criterion-related validity of knee joint-position-sense measurement using image capture and isokinetic dynamometry. J Sport Rehabil. 2015 Jan 13;24(1):2013-0119. doi: 10.1123/jsr.2013-0119. Print 2015 Feb 1.
PubMed 25310567Mir SM, Hadian MR, Talebian S, Nasseri N. Functional assessment of knee joint position sense following anterior cruciate ligament reconstruction. Br J Sports Med. 2008 Apr;42(4):300-3. doi: 10.1136/bjsm.2007.044875.
PubMed 18390774Bolgla LA, Boling MC. An update for the conservative management of patellofemoral pain syndrome: a systematic review of the literature from 2000 to 2010. Int J Sports Phys Ther. 2011 Jun;6(2):112-25.
PubMed 21713229
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Autocad Software Assessment of Joint Position Sense in Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT03685812
- Acronym / sponsor ID
- patellofemoral pain syndrome
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral Pain Syndrome, Autocad software, position sense, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 26 Sep 2018 (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 overall aim of the study is to assess the reliability and validity of Autocad software to measure JPS in PFPS, especially:
- To assess the intra-tester and between day reliability of measurement of JPS using Autocad software.
- To assess the validity of these measurements against those found during an IKD.
Detailed description
Patellofemoral pain syndrome (PFPS) is a common painful musculoskeletal condition that affects physically active young adults and adolescents.
Joint position sense (JPS) is considered as a component of proprioception as it provides the clinician with information regarding the accuracy of movement as well as its relationship with movement performance and injuries. Therefore researchers use advanced instruments as 3 D video systems and isokinetic dynamometer. Since these instruments are less portable and expensive, therefore researchers used another method to evaluate JPS using high precision software using video analysis and markers in the joints. Unfortunately, video analysis requires difficult and time-consuming tasks and that this slow the evaluation process.
Although immediate feedback could help physiotherapists and athletic trainers to monitor athletes and make decisions during the training session and the rehabilitation process, such immediacy is not available for proprioceptive tests in field situations. Autocad software is available and inexpensive and provides immediate feedback
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with patellofemoral pain syndrome , Auto Cad software | – | Diagnostic Test: Autocad softwarePatients referred with a confirmed diagnosis of patellofemoral pain syndrome, with a visual analogue scale of more than 3. 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- thirty-eight patients(males and females) with PFPS will be recruited from the outpatient clinic of the faculties of Physical Therapy, Cairo University, Egypt.
Key inclusion criteria (4 listed)
- 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; (6) hopping/jumping; (7) kneel sitting
- Insidious onset of symptoms unrelated to a traumatic incident.
- 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.
- 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 weren'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 |
|---|---|---|
| Autocad softwareAlso: Isokinetic systemThe participants will be prepared for image-capture data collection by putting four squared markers on leg and thigh.Each subject will extend his/her leg and make two angles from the resting position (90º) to the full extension, photos will be taken. The tested leg passively moved by the researcher through 20° to 60° of knee extension, 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. The angles will be measured using the AutoCAD software. Knee JPS measurements will also be collected using an IKD by same steps | Diagnostic test | patients with patellofemoral pain syndrome , Auto Cad software |
Primary outcome
Concurrent validity of Autocad software
Time frame: one day
correlation between absolute angular error of Autocad software and isokinetic system
1 secondary outcome
Intrarater reliability of
Time frame: 48 hours
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 1 Apr 2019.
- Background: PubMed 19158451Akseki D, Akkaya G, Erduran M, Pinar H. [Proprioception of the knee joint in patellofemoral pain syndrome]. Acta Orthop Traumatol Turc. 2008 Nov-Dec;42(5):316-21. doi: 10.3944/aott.2008.316. Turkish.
- Background: PubMed 11918299Baker V, Bennell K, Stillman B, Cowan S, Crossley K. Abnormal knee joint position sense in individuals with patellofemoral pain syndrome. J Orthop Res. 2002 Mar;20(2):208-14. doi: 10.1016/S0736-0266(01)00106-1.
- Background: PubMed 14508689Drouin JM, Valovich-mcLeod TC, Shultz SJ, Gansneder BM, Perrin DH. Reliability and validity of the Biodex system 3 pro isokinetic dynamometer velocity, torque and position measurements. Eur J Appl Physiol. 2004 Jan;91(1):22-9. doi: 10.1007/s00421-003-0933-0. Epub 2003 Sep 24.
- Background: PubMed 25310567Relph N, Herrington L. Criterion-related validity of knee joint-position-sense measurement using image capture and isokinetic dynamometry. J Sport Rehabil. 2015 Jan 13;24(1):2013-0119. doi: 10.1123/jsr.2013-0119. Print 2015 Feb 1.
- Background: PubMed 18390774Mir SM, Hadian MR, Talebian S, Nasseri N. Functional assessment of knee joint position sense following anterior cruciate ligament reconstruction. Br J Sports Med. 2008 Apr;42(4):300-3. doi: 10.1136/bjsm.2007.044875.
- Background: PubMed 21713229Bolgla LA, Boling MC. An update for the conservative management of patellofemoral pain syndrome: a systematic review of the literature from 2000 to 2010. Int J Sports Phys Ther. 2011 Jun;6(2):112-25.
- Individual participant dataSharing planned: No
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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.
karima A Hassan principal investigator
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: finished, as of the sponsor's last update on 1 Apr 2019. 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?
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?
Concurrent validity of Autocad software (time frame: one day). 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 NCT03685812, which also lists 6 linked publications.
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 1 Apr 2019.