Chondromalacia PatellaeNCT04589702
Temporal Activation of Core Muscles and Vasti in Isolated Patellofemoral Osteoarthritis
An observational study of Chondromalacia Patellae, run by Cairo University at 1 site in Egypt.
Trial summary
Objective: To compare the temporal muscle activation between females with PF OA and normal controls during stair ascent. Methods: An observational comparative study was conducted with thirty-one females with PF OA and 11 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
- 1 Mar 2019to 30 Sep 2020
- 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 were recruited from the Outpatient Clinic of Kasr Al-Ainy Hospital and the Faculty of Physical Therapy, Cairo University as well. However, control subjects were recruited via advertising in the local community.
Who may be able to join
- 1. no history of knee pathology or pain with any of the provocative activities which were mentioned above.
Who cannot join
- 1. concomitant pain from tibiofemoral joint or other knee structures .
- current or previous pain in the hip, lumbar spine or foot that had 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, were also excluded .
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporal Activation of Core Muscles and Vasti in Isolated Patellofemoral Osteoarthritis During Stair-stepping
Objective: To compare the temporal muscle activation between females with PF OA and normal controls during stair ascent. Methods: An observational comparative study was conducted with thirty-one females with PF OA and 11 healthy ones. The onset times of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti muscles were measured by quantitative Electromyography during stair ascent task. hypothesis: Investigators hypothesized that there won't be a significant difference between females with PF OA and their matched healthy group regarding the onset times of vastus medialis obliqus (VMO), vastus lateralis (VL), gluteus medius (GM), multifidus, and transversus abdominus (TrA), during stair ascent task.
Read the detailed description
Investigators collected 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 high-resolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada). Electromyographic data were sampled at 1000 Hz and bandpass filtered at 50-200 Hz.
For each muscle, three electrodes were used; two electrodes were placed ~ 30 mm apart in the direction of the muscle fibers and a ground electrode was placed over the closest bony prominence. Before placement of the electrodes, the subject's skin was cleaned with alcohol to reduce impedance and excess hair was removed to eliminate shifting of the electrodes if needed.
The stair-stepping task consisted of ascending 2 steps (each step was 40 cm in width, 20 cm in height, without handrails. The depth of the first and second steps was 30 cm and 40 cm, respectively) . Participants were asked to stand on the floor confronting the stairs and 20 cm away from the edge of the initial step. The stair ascent task was performed barefooted while arms hanged at the side of the body. Patients started ascending the steps immediately in response to a command, at their normal speed with their affected limb. Investigators didn't control the speed of stair ascent, because controlling the timing of stair-stepping can alter the electromyographic signal as shown earlier for gait in asymptomatic subjects. Healthy subjects started ascending stairs with their dominant limb .
Before data acquisition, participants performed one practice trial of stair ascent to get familiarized with the task. Then the participants performed three test trials with thirty seconds of rest after each trial to prevent fatigue. The raw data were stored on a personal computer for analysis with a custom program in Matlab (Math Works, Natick, Massachusetts, USA). Investigators used a mean of data in three trials for analysis.
Statistical Analysis:
Data management and analysis were conducted using the statistical package for social studies (SPSS) version 22 for windows (IBM SPSS, Chicago, IL, USA). Normal distribution of the data was tested using the Shapiro-Wilk test. The homogeneity of variances between groups was examined using Levene's test. Descriptive data are expressed as mean ± standard deviation. An independent t-test was conducted for comparison of subject characteristics; age, body mass index (BMI), weight and height, between both groups. A univariate test of one way MANOVA was performed to compare EMG onset of each muscle between both groups. Post-hoc analysis using the Bonferroni method was carried out for subsequent multiple comparison. The level of significance for all statistical tests was set at p < 0.05.
- 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 EMG onset of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti muscles
investigators collected 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 high-resolution wireless bio amplifier (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 posted19 Oct 2020
- Study start1 Mar 2019
- Primary completion10 Oct 2019
- Study completion30 Sep 2020
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, afaf mohamed omar tahoon, Cairo University
- Investigators
- Aladdin A. balbaa, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589702
- Sponsor's protocol ID
- (P.T.Rec/012/001659)
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 19 Oct 2020
- 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Activation of Core Muscles and Vasti in Isolated Patellofemoral Osteoarthritis During Stair-stepping
- ClinicalTrials.gov ID
- NCT04589702
- Acronym / sponsor ID
- (P.T.Rec/012/001659)
- Conditions
- Chondromalacia Patellae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 19 Oct 2020 (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 compare the temporal muscle activation between females with PF OA and normal controls during stair ascent. Methods: An observational comparative study was conducted with thirty-one females with PF OA and 11 healthy ones. The onset times of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti muscles were measured by quantitative Electromyography during stair ascent task. hypothesis: Investigators hypothesized that there won't be a significant difference between females with PF OA and their matched healthy group regarding the onset times of vastus medialis obliqus (VMO), vastus lateralis (VL), gluteus medius (GM), multifidus, and transversus abdominus (TrA), during stair ascent task.
Detailed description
Investigators collected 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 high-resolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada). Electromyographic data were sampled at 1000 Hz and bandpass filtered at 50-200 Hz.
For each muscle, three electrodes were used; two electrodes were placed ~ 30 mm apart in the direction of the muscle fibers and a ground electrode was placed over the closest bony prominence. Before placement of the electrodes, the subject's skin was cleaned with alcohol to reduce impedance and excess hair was removed to eliminate shifting of the electrodes if needed.
The stair-stepping task consisted of ascending 2 steps (each step was 40 cm in width, 20 cm in height, without handrails. The depth of the first and second steps was 30 cm and 40 cm, respectively) . Participants were asked to stand on the floor confronting the stairs and 20 cm away from the edge of the initial step. The stair ascent task was performed barefooted while arms hanged at the side of the body. Patients started ascending the steps immediately in response to a command, at their normal speed with their affected limb. Investigators didn't control the speed of stair ascent, because controlling the timing of stair-stepping can alter the electromyographic signal as shown earlier for gait in asymptomatic subjects. Healthy subjects started ascending stairs with their dominant limb .
Before data acquisition, participants performed one practice trial of stair ascent to get familiarized with the task. Then the participants performed three test trials with thirty seconds of rest after each trial to prevent fatigue. The raw data were stored on a personal computer for analysis with a custom program in Matlab (Math Works, Natick, Massachusetts, USA). Investigators used a mean of data in three trials for analysis.
Statistical Analysis:
Data management and analysis were conducted using the statistical package for social studies (SPSS) version 22 for windows (IBM SPSS, Chicago, IL, USA). Normal distribution of the data was tested using the Shapiro-Wilk test. The homogeneity of variances between groups was examined using Levene's test. Descriptive data are expressed as mean ± standard deviation. An independent t-test was conducted for comparison of subject characteristics; age, body mass index (BMI), weight and height, between both groups. A univariate test of one way MANOVA was performed to compare EMG onset of each muscle between both groups. Post-hoc analysis using the Bonferroni method was carried out for subsequent multiple comparison. The level of significance for all statistical tests was set at p < 0.05.
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 were recruited from the Outpatient Clinic of Kasr Al-Ainy Hospital and the Faculty of Physical Therapy, Cairo University as well. However, control subjects were recruited via advertising in the local community.
Key inclusion criteria (1 listed)
- 1. no history of knee pathology or pain with any of the provocative activities which were mentioned above.
Key exclusion criteria (6 listed)
- 1. concomitant pain from tibiofemoral joint or other knee structures .
- -
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 EMG onset of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti muscles
Time frame: from admission to discharge, up to two weeks
investigators collected 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 high-resolution wireless bio amplifier (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 19 Oct 2020.
- 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.
Aladdin A. balbaa, professor study director
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 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 1 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 19 Oct 2020. 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 EMG onset of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti muscles (time frame: from admission to discharge, up to two weeks). 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 19 Oct 2020.