Chondromalacia PatellaeNCT05407077
Is Lower Limb Neuromotor Control Diverse in Females With PF OA Contrasted With Asymptomatic Controls
An observational study of Chondromalacia Patellae, run by Cairo University at 1 site in Egypt.
Trial summary
Objective: to investigate whether females with PF OA descend stairs with different muscular recruitment strategies contrasted with similar aged healthy females. Methods: An observational comparative study will be conducted with thirty females with PF OA and 10 healthy ones. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Chondromalacia Patellae
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2022to 2 Jan 2023
- 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 35 to 55 years
- Women only
- Adult
Study population: Patients will be recruited from the Outpatient Clinic of Kasr Al-Ainy Hospital and the Faculty of Physical Therapy, Cairo University as well. However, control subjects will be recruited via advertising in the local community.
Who may be able to join
- • Inclusion Criteria for PF OA group; patients will be included if they have
- Anterior- or retro-patellar knee pain aggravated by at least two activities that load the PFJ (eg; stair ambulation, squatting and/or rising from sitting) .
- Pain during these activities presented on most days during the past month and their pain severity was ≥ 4 on an 11 point numerical pain scale during aggravating activities .,
- A grade less than (2) from postero-anterior views on the Kellgren - Lawrence (KL) grading scale.
- 1. no history of knee pathology or pain with any of the provocative activities which were mentioned above
Who cannot join
- • Exclusion Criteria for Patients in the PF OA group:
- concomitant pain from tibiofemoral joint or other knee structures . • Exclusion Criteria for Subjects from both groups:
- <!-- -->
- current or previous pain in the hip, lumbar spine or foot that lasted longer than 3 months and/or required intervention.
- a history of lower extremity, pelvis or spine fractures; spine, hip, knee or foot surgeries; hip or patellar subluxation/ dislocation.
- injury to any of knee ligaments or meniscus.
- systemic diseases (e.g. rheumatoid arthritis), neurological conditions or fibromyalgia . 5.The professional athletes; people who exercise more than two hours a day or every other day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Lower Limb Neuromotor Control Diverse in Females With PF OA Contrasted With Asymptomatic Controls When Performing Stair Descent Task?
Objective: to investigate whether females with PF OA descend stairs with different muscular recruitment strategies contrasted with similar aged healthy females.
Methods: An observational comparative study will be conducted with thirty females with PF OA and 10 healthy ones. The onset times and electromyography (EMG) duration of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti muscles will be measured by quantitative EMG during stair descent task. hypothesis: Investigators hypothesize that there won't be a significant difference between females with PF OA and their matched healthy group regarding the onset times and duration of vastus medialis obliqus (VMO), vastus lateralis (VL), gluteus medius (GM), multifidus, and transversus abdominus (TrA), during stair descent task.
Read the detailed description
Investigators will collect the EMG activity of VMO, VL, GM, multifidus, and TrA using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels highresolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada). Electromyographic data will be sampled at 1000 Hz and bandpass filtered at 50-200 Hz. For each muscle, three electrodes will be used; two electrodes will be placed ~30 mm apart in the direction of the muscle fibers and a ground electrode will be placed over the closest bony prominence. Before placement of the electrodes, the subject's skin will be cleaned with alcohol to reduce impedance and excess hair will be removed to eliminate shifting of the electrodes if needed. The stair-stepping task consists of descending 2 steps. Patients should start descending the steps immediately in response to a command, at their normal speed with their affected limb. Healthy subjects should start descending stairs with their dominant limb . Before data acquisition, participants should perform one practice trial of stair descent to get familiarized with the task. Then the participants should perform three test trials with thirty seconds of rest after each trial to prevent fatigue. The raw data will be stored on a personal computer for analysis with a custom program in Matlab (Math Works, Natick, Massachusetts, USA). Investigators should use a mean of data in three trials for analysis.
- Conditions
- Chondromalacia Patellae
- Medical subject headings
- Chondromalacia Patellae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| females with isolated patellofemoral arthritis | those with anterior knee pain | |
| healthy females | those without anterior knee pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of EMG onset of multifidus
investigators will collect the EMG activity of multifidus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
Measured: from admission to discharge, up to two weeks
The change of EMG duration of multifidus
investigators will collect the EMG activity of multifidus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
Measured: from admission to discharge, up to two weeks
The change of EMG duration of transversus abdominus
investigators will collect the EMG activity of transversus abdominus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
Measured: from admission to discharge, up to two weeks
The change of EMG onset of transversus abdominus
investigators will collect the EMG activity of transversus abdominus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
Measured: from admission to discharge, up to two weeks
The change of EMG onset of gluteus medius
investigators will collect the EMG activity of gluteus medius using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
Measured: from admission to discharge, up to two weeks
The change of EMG duration of gluteus medius
investigators will collect the EMG activity of gluteus medius using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
Measured: from admission to discharge, up to two weeks
The change of EMG onset of vastus medialis obliqus
investigators will collect the EMG activity of vastus medialis obliqus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
Measured: from admission to discharge, up to two weeks
The change of EMG duration of vastus medialis obliqus
investigators will collect the EMG activity of vastus medialis obliqus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
Measured: from admission to discharge, up to two weeks
The change of EMG duration of vastus lateralis
investigators will collect the EMG activity of vastus lateralis using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
Measured: from admission to discharge, up to two weeks
The change of EMG onset of vastus lateralis
investigators will collect the EMG activity of vastus lateralis using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
Measured: from admission to discharge, up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start30 Jun 2022
- Primary completion13 Dec 2022
- Study completion2 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chondromalacia PatellaeStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jilan Adel yousef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407077
- Sponsor's protocol ID
- P.T.REC/012/003437
- Status last verified
- Aug 2023
- First submitted
- 2 Jun 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Lower Limb Neuromotor Control Diverse in Females With PF OA Contrasted With Asymptomatic Controls When Performing Stair Descent Task?
- ClinicalTrials.gov ID
- NCT05407077
- Acronym / sponsor ID
- P.T.REC/012/003437
- Conditions
- Chondromalacia Patellae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 7 Jun 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.
Objective: to investigate whether females with PF OA descend stairs with different muscular recruitment strategies contrasted with similar aged healthy females.
Methods: An observational comparative study will be conducted with thirty females with PF OA and 10 healthy ones. The onset times and electromyography (EMG) duration of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti muscles will be measured by quantitative EMG during stair descent task. hypothesis: Investigators hypothesize that there won't be a significant difference between females with PF OA and their matched healthy group regarding the onset times and duration of vastus medialis obliqus (VMO), vastus lateralis (VL), gluteus medius (GM), multifidus, and transversus abdominus (TrA), during stair descent task.
Detailed description
Investigators will collect the EMG activity of VMO, VL, GM, multifidus, and TrA using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels highresolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada). Electromyographic data will be sampled at 1000 Hz and bandpass filtered at 50-200 Hz. For each muscle, three electrodes will be used; two electrodes will be placed ~30 mm apart in the direction of the muscle fibers and a ground electrode will be placed over the closest bony prominence. Before placement of the electrodes, the subject's skin will be cleaned with alcohol to reduce impedance and excess hair will be removed to eliminate shifting of the electrodes if needed. The stair-stepping task consists of descending 2 steps. Patients should start descending the steps immediately in response to a command, at their normal speed with their affected limb. Healthy subjects should start descending stairs with their dominant limb . Before data acquisition, participants should perform one practice trial of stair descent to get familiarized with the task. Then the participants should perform three test trials with thirty seconds of rest after each trial to prevent fatigue. The raw data will be stored on a personal computer for analysis with a custom program in Matlab (Math Works, Natick, Massachusetts, USA). Investigators should use a mean of data in three trials for analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| females with isolated patellofemoral arthritis | – | –those with anterior knee pain |
| healthy females | – | –those without anterior knee pain |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients will be recruited from the Outpatient Clinic of Kasr Al-Ainy Hospital and the Faculty of Physical Therapy, Cairo University as well. However, control subjects will be recruited via advertising in the local community.
Key inclusion criteria (5 listed)
- • Inclusion Criteria for PF OA group; patients will be included if they have
- 1. no history of knee pathology or pain with any of the provocative activities which were mentioned above
Key exclusion criteria (7 listed)
- • Exclusion Criteria for Patients in the PF OA group:
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change of EMG onset of multifidus
Time frame: from admission to discharge, up to two weeks
investigators will collect the EMG activity of multifidus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
The change of EMG duration of multifidus
Time frame: from admission to discharge, up to two weeks
investigators will collect the EMG activity of multifidus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
The change of EMG duration of transversus abdominus
Time frame: from admission to discharge, up to two weeks
investigators will collect the EMG activity of transversus abdominus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
The change of EMG onset of transversus abdominus
Time frame: from admission to discharge, up to two weeks
investigators will collect the EMG activity of transversus abdominus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
The change of EMG onset of gluteus medius
Time frame: from admission to discharge, up to two weeks
investigators will collect the EMG activity of gluteus medius using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
The change of EMG duration of gluteus medius
Time frame: from admission to discharge, up to two weeks
investigators will collect the EMG activity of gluteus medius using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
The change of EMG onset of vastus medialis obliqus
Time frame: from admission to discharge, up to two weeks
investigators will collect the EMG activity of vastus medialis obliqus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
The change of EMG duration of vastus medialis obliqus
Time frame: from admission to discharge, up to two weeks
investigators will collect the EMG activity of vastus medialis obliqus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
The change of EMG duration of vastus lateralis
Time frame: from admission to discharge, up to two weeks
investigators will collect the EMG activity of vastus lateralis using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
The change of EMG onset of vastus lateralis
Time frame: from admission to discharge, up to two weeks
investigators will collect the EMG activity of vastus lateralis using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
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 Sep 2023.
- 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.
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?
An observational study of Chondromalacia Patellae, 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 5 inclusion and 7 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 Sep 2023. 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?
The change of EMG onset of multifidus (time frame: from admission to discharge, up to two weeks). The study lists 10 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 1 Sep 2023.