Chondromalacia PatellaeNCT05597670
Effect of Proximal Stabilization on Recruitment of the Core & Vasti in Patellofemoral Arthritis During Descending Stairs
A study testing traditional knee rehabilitation program and proximal stabilization in people with Chondromalacia Patellae, run by Cairo University at 1 site in Egypt.
Trial summary
Purpose: to investigate the effect of proximal stability on PF OA. Methods: Thirty patients with PF OA will be recruited. Patients will be randomly assigned into two groups, group A and group B . Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Chondromalacia Patellae
- What is being tested?
- traditional knee rehabilitation program and proximal stabilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Nov 2022to 1 Jun 2024
- 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 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 .
- The professional athletes; people who exercise more than two hours a day or every other day, will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Proximal Stabilization on Recruitment of the Core & Vasti in Patients With Patellofemoral Arthritis as They Descend Stairs
Purpose: to investigate the effect of proximal stability on PF OA. Methods: Thirty patients with PF OA will be recruited. Patients will be randomly assigned into two groups, group A and group B . Patients in both groups will receive a traditional physical therapy treatment, but group (B) will receive additional proximal stability exercise. All patients will be evaluated for muscular recruitment strategies (onset and duration) of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti measured by quantitative Electromyography during stair descent. pre and post-treatment.
Read the detailed description
: A) Procedures for evaluation: The practical section of the studywill be undertaken in 6 weeks (2 sessions a week). Measurement will be taken before the start of treatment program then after the end of 6 weeks treatment program. 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 stairstepping task will consist of descending 2 steps Before data acquisition, participants will be asked to perform one practice trial of stair descent to get familiarized with the task. Then the participants will 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 . Investigators will use a mean of data in three trials for analysis.
- Procedures for treatment: All patients will receive a traditional physical therapy program in the form of TENS , stretching hamstring, quadriceps and calf muscles
- Group (A) Patients in this group will receive a traditional therapeutic knee rehabilitation program in the form of mini-squatting exercise (up to 45 degrees knee flexion measured by a universal goniometer) , strengthening of hip abductors and external rotators using clamshell exercise . No emphasis will be placed on stabilizing the core musculature before initiating any of those exercises.
- Group (B) Patients in this group will receive the same program as group (A) plus proximal stability exercise and the principles of proximal stability will be explained to patients before initiation of treatment and patients will be asked to comply with these principles during exercise. These principles include learning how to activate transversus abdominus by abdominal bracing without allowing pelvis tilting and ensure neutral spine and diaphragmatic breathing during exercise.
- Conditions
- Chondromalacia Patellae
- Being tested
- traditional knee rehabilitation program, proximal stabilization
- Medical subject headings
- Chondromalacia Patellae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional knee rehabilitation programOther
Patients in this group will receive a traditional therapeutic knee rehabilitation program in the form of mini-squatting exercise (up to 45 degree knee flexion measured by a universal goniometer) , strengthening of hip abductors and external rotators
proximal stabilizationOther
the principles of proximal stability will be explained to patients before initiation of treatment and patients will be asked to comply with these principles during exercise. These principles include learning how to activate transversus abdominus by abdominal bracing without allowing pelvis tilting and ensure neutral spine and diaphragmatic breathing during exercise.
| Study group | Role | What they receive |
|---|---|---|
| group A | Other | Patients in this group will receive a traditional therapeutic knee rehabilitation program in the form of mini-squatting exercise (up to 45 degree knee flexion measured by a universal goniometer) , strengthening of hip abductors and external rotators Receives: Other: traditional knee rehabilitation program |
| group B | Experimental | Patients in this group will receive the same program as group (A) plus proximal stabilization exercise Receives: Other: traditional knee rehabilitation program; Other: proximal stabilization |
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 by electromyography (EMG) using surface electrodes
Measured: baseline and six weeks
The change of EMG duration of multifidus
investigators will collect the EMG activity of multifidus by electromyography (EMG) using surface electrodes
Measured: baseline and six weeks
The change of EMG duration of vastus medialis obliqus
investigators will collect the EMG activity of vastus medialis obliqus by electromyography (EMG) using surface electrodes
Measured: baseline and six weeks
The change of EMG onset of vastus medialis obliqus
investigators will collect the EMG activity of vastus medialis obliqus by electromyography (EMG) using surface electrodes
Measured: baseline and six weeks
The change of EMG onset of vastus lateralis
investigators will collect the EMG activity of vastus lateralis by electromyography (EMG) using surface electrodes
Measured: baseline and six weeks
The change of EMG duration of vastus lateralis
investigators will collect the EMG activity of vastus lateralis by electromyography (EMG) using surface electrodes
Measured: baseline and six weeks
The change of EMG duration of gluteus medius
investigators will collect the EMG activity of gluteus medius by electromyography (EMG) using surface electrodes
Measured: baseline and six weeks
The change of EMG onset of gluteus medius
investigators will collect the EMG activity of gluteus medius by electromyography (EMG) using surface electrodes
Measured: baseline and six weeks
The change of EMG onset of transversus abdominus
investigators will collect the EMG activity of transversus abdominus by electromyography (EMG) using surface electrodes
Measured: baseline and six weeks
The change of EMG duration of transversus abdominus
investigators will collect the EMG activity of transversus abdominus by electromyography (EMG) using surface electrodes
Measured: baseline and six weeks
Secondary outcomes (1)
kinesiophobia
patients will respond to the questions of the Tempa scale
Measured: baseline and six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start29 Nov 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned into two groups, group A and group B . Patients in both groups will receive a traditional physical therapy treatment, but group (B) will receive additional proximal stability exercise.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 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
- NCT05597670
- Sponsor's protocol ID
- P.T.REC/012/003438
- Status last verified
- Jun 2024
- First submitted
- 25 Oct 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proximal Stabilization on Recruitment of the Core & Vasti in Patients With Patellofemoral Arthritis as They Descend Stairs
- ClinicalTrials.gov ID
- NCT05597670
- Acronym / sponsor ID
- P.T.REC/012/003438
- Conditions
- Chondromalacia Patellae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 28 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.
Purpose: to investigate the effect of proximal stability on PF OA. Methods: Thirty patients with PF OA will be recruited. Patients will be randomly assigned into two groups, group A and group B . Patients in both groups will receive a traditional physical therapy treatment, but group (B) will receive additional proximal stability exercise. All patients will be evaluated for muscular recruitment strategies (onset and duration) of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti measured by quantitative Electromyography during stair descent. pre and post-treatment.
Detailed description
: A) Procedures for evaluation: The practical section of the studywill be undertaken in 6 weeks (2 sessions a week). Measurement will be taken before the start of treatment program then after the end of 6 weeks treatment program. 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 stairstepping task will consist of descending 2 steps Before data acquisition, participants will be asked to perform one practice trial of stair descent to get familiarized with the task. Then the participants will 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 . Investigators will use a mean of data in three trials for analysis.
- Procedures for treatment: All patients will receive a traditional physical therapy program in the form of TENS , stretching hamstring, quadriceps and calf muscles
- Group (A) Patients in this group will receive a traditional therapeutic knee rehabilitation program in the form of mini-squatting exercise (up to 45 degrees knee flexion measured by a universal goniometer) , strengthening of hip abductors and external rotators using clamshell exercise . No emphasis will be placed on stabilizing the core musculature before initiating any of those exercises.
- Group (B) Patients in this group will receive the same program as group (A) plus proximal stability exercise and the principles of proximal stability will be explained to patients before initiation of treatment and patients will be asked to comply with these principles during exercise. These principles include learning how to activate transversus abdominus by abdominal bracing without allowing pelvis tilting and ensure neutral spine and diaphragmatic breathing during exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned into two groups, group A and group B . Patients in both groups will receive a traditional physical therapy treatment, but group (B) will receive additional proximal stability exercise.
| Arm | Type | Receives |
|---|---|---|
| group A | Other | Other: traditional knee rehabilitation programPatients in this group will receive a traditional therapeutic knee rehabilitation program in the form of mini-squatting exercise (up to 45 degree knee flexion measured by a universal goniometer) , strengthening of hip abductors and external rotators |
| group B | Experimental | Other: traditional knee rehabilitation program, Other: proximal stabilizationPatients in this group will receive the same program as group (A) plus proximal stabilization exercise |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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 .
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 |
|---|---|---|
| traditional knee rehabilitation programPatients in this group will receive a traditional therapeutic knee rehabilitation program in the form of mini-squatting exercise (up to 45 degree knee flexion measured by a universal goniometer) , strengthening of hip abductors and external rotators | Other | group A, group B |
| proximal stabilizationthe principles of proximal stability will be explained to patients before initiation of treatment and patients will be asked to comply with these principles during exercise. These principles include learning how to activate transversus abdominus by abdominal bracing without allowing pelvis tilting and ensure neutral spine and diaphragmatic breathing during exercise. | Other | group B |
Primary outcome
The change of EMG onset of multifidus
Time frame: baseline and six weeks
investigators will collect the EMG activity of multifidus by electromyography (EMG) using surface electrodes
The change of EMG duration of multifidus
Time frame: baseline and six weeks
investigators will collect the EMG activity of multifidus by electromyography (EMG) using surface electrodes
The change of EMG duration of vastus medialis obliqus
Time frame: baseline and six weeks
investigators will collect the EMG activity of vastus medialis obliqus by electromyography (EMG) using surface electrodes
The change of EMG onset of vastus medialis obliqus
Time frame: baseline and six weeks
investigators will collect the EMG activity of vastus medialis obliqus by electromyography (EMG) using surface electrodes
The change of EMG onset of vastus lateralis
Time frame: baseline and six weeks
investigators will collect the EMG activity of vastus lateralis by electromyography (EMG) using surface electrodes
The change of EMG duration of vastus lateralis
Time frame: baseline and six weeks
investigators will collect the EMG activity of vastus lateralis by electromyography (EMG) using surface electrodes
The change of EMG duration of gluteus medius
Time frame: baseline and six weeks
investigators will collect the EMG activity of gluteus medius by electromyography (EMG) using surface electrodes
The change of EMG onset of gluteus medius
Time frame: baseline and six weeks
investigators will collect the EMG activity of gluteus medius by electromyography (EMG) using surface electrodes
The change of EMG onset of transversus abdominus
Time frame: baseline and six weeks
investigators will collect the EMG activity of transversus abdominus by electromyography (EMG) using surface electrodes
The change of EMG duration of transversus abdominus
Time frame: baseline and six weeks
investigators will collect the EMG activity of transversus abdominus by electromyography (EMG) using surface electrodes
1 secondary outcome
kinesiophobia
Time frame: baseline and six 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 4 Jun 2024.
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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 traditional knee rehabilitation program and proximal stabilization in people with 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 3 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 4 Jun 2024. 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: baseline and six 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 4 Jun 2024.