Chondromalacia PatellaeNCT04669834
Effect of Core Stability Exercise on Isolated Patellofemoral Osteoarthritis.
A study testing a traditional therapeutic knee rehabilitation program and core stability exercise in people with Chondromalacia Patellae, run by Cairo University at 1 site in Egypt.
Trial summary
Purpose: to investigate the effect of core stability on PF OA. Methods: Thirty-one females 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?
- a traditional therapeutic knee rehabilitation program and core stability exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Nov 2020to 28 Aug 2022
- 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 Core Stability Exercise on Temporal Activation of Core Muscles and Vasti in Isolated Patellofemoral Osteoarthritis.
Purpose: to investigate the effect of core stability on PF OA. Methods: Thirty-one females 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 core stability exercise. All patients will be evaluated for pain, functional performance, and muscular recruitment strategies (onset and duration) of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti measured by quantitative Electromyography during stair ascent. pre and post-treatment.
Read the detailed description
- 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 f in the following manner:
- Patients will be asked to respond to the questions of the Kujala scale.
- The eleven-point numerical rating scale will be used to measure pain severity
- 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 will consist of ascending 2 steps (each step will be 40 cm in width, 20 cm in height, without handrails. The depth of the first and second steps will be 30 cm and 40 cm, respectively) . Participants will be asked to stand on the floor confronting the stairs and 20 cm away from the edge of the initial step. The stair ascent task will be performed barefooted while arms hanged at the side of the body. Patients will start ascending the steps immediately in response to a command, at their normal speed with their affected limb. Investigators aren't going to 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. Before data acquisition, participants will be asked to perform one practice trial of stair ascent 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 (Math Works, Natick, Massachusetts, USA). Investigators will use a mean of data in three trials for analysis. b) 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 based on a recent systematic review in the form of mini-squatting exercise (up to 45O 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. To increase the intensity of exercise, elastic resistance bands will be used.
- Group (B) Patients in this group will receive the same program as group (A) plus core stability exercise and the principles of core 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.
- Statistical Analysis: Data management and analysis will be conducted using the statistical package for social studies (SPSS) version 22 for windows (IBM SPSS, Chicago, IL, USA). Investigators will conduct the 2X2 Mixed Design MANOVA test to compare the onset and duration of each muscle, pain intensity, and performance of functional activities between group A (traditional therapeutic knee rehabilitation) and group B (core stability) pre-treatment and post-treatment.
- Conditions
- Chondromalacia Patellae
- Being tested
- a traditional therapeutic knee rehabilitation program, core stability exercise
- Medical subject headings
- Chondromalacia Patellae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a traditional therapeutic knee rehabilitation programOther
mini-squatting exercise and clamshell exercise
core stability exerciseOther
the principles of core 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 based on a recent systematic review 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 using clamshell exercise . No emphasis will be placed on stabilizing the core musculature before initiating any of those exercises. Receives: Other: a traditional therapeutic knee rehabilitation program |
| group B | Experimental | Patients in this group will receive the same program as group (A) plus core stability exercise , but the principles of core 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. Receives: Other: a traditional therapeutic knee rehabilitation program; Other: core stability exercise |
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 bio amplifier (WBA) system (Biomation, Almonte, Canada).
Measured: baseline and six 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 bio amplifier (WBA) system (Biomation, Almonte, Canada).
Measured: baseline and six weeks
The change of EMG onset of transversus abdominus (TrA) muscle
investigators will collect the EMG activity of 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: baseline and six weeks
The change of EMG duration of transversus abdominus (TrA) muscle
investigators will collect the EMG activity of 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: baseline and six weeks
The change of EMG onset of gluteus medius (GM) muscle
investigators will collect the EMG activity of GM 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: baseline and six weeks
The change of EMG duration of gluteus medius (GM) muscle
investigators will collect the EMG activity of GM 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: baseline and six weeks
The change of EMG onset of vastus medialis obliqus (VMO) muscle
investigators will collect the EMG activity of VMO 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: baseline and six weeks
The change of EMG duration of vastus medialis obliqus (VMO) muscle
investigators will collect the EMG activity of VMO 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: baseline and six weeks
The change of EMG onset of vastus lateralis (VL) muscle
investigators will collect the EMG activity of VL 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: baseline and six weeks
The change of EMG duration of vastus lateralis (VL) muscle
investigators will collect the EMG activity of VL 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: baseline and six weeks
Secondary outcomes (2)
pain intensity
The eleven-point numerical rating scale will be used to measure pain severity for patients.where the endpoints are the extremes of no pain and pain as bad as it could be or worst pain. increasing the value means more intense pain.
Measured: baseline and six weeks
performance of functional activities
kujala scale will be used to evaluate the performance of functional activities. This questionnaire includes 13 questions and the scores range from 0 to 100, where 100 indicates the highest efficiency of the knee and 0 indicates the highest disability.
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 posted17 Dec 2020
- Study start19 Nov 2020
- Primary completion20 Aug 2022
- Study completion28 Aug 2022
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 core stability exercise.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jilan Adel yousef, Cairo University
- Investigators
- Aladdin A. balbaa, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669834
- Sponsor's protocol ID
- (P.T.Rec/012/002987)
- Status last verified
- Sep 2022
- First submitted
- 2 Dec 2020
- Last updated
- 21 Sep 2022
- 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 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Stability Exercise on Temporal Activation of Core Muscles and Vasti in Isolated Patellofemoral Osteoarthritis.
- ClinicalTrials.gov ID
- NCT04669834
- Acronym / sponsor ID
- (P.T.Rec/012/002987)
- Conditions
- Chondromalacia Patellae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 28 Aug 2022 (actual)
- First posted
- 17 Dec 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.
Purpose: to investigate the effect of core stability on PF OA. Methods: Thirty-one females 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 core stability exercise. All patients will be evaluated for pain, functional performance, and muscular recruitment strategies (onset and duration) of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti measured by quantitative Electromyography during stair ascent. pre and post-treatment.
Detailed description
- 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 f in the following manner:
- Patients will be asked to respond to the questions of the Kujala scale.
- The eleven-point numerical rating scale will be used to measure pain severity
- 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 will consist of ascending 2 steps (each step will be 40 cm in width, 20 cm in height, without handrails. The depth of the first and second steps will be 30 cm and 40 cm, respectively) . Participants will be asked to stand on the floor confronting the stairs and 20 cm away from the edge of the initial step. The stair ascent task will be performed barefooted while arms hanged at the side of the body. Patients will start ascending the steps immediately in response to a command, at their normal speed with their affected limb. Investigators aren't going to 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. Before data acquisition, participants will be asked to perform one practice trial of stair ascent 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 (Math Works, Natick, Massachusetts, USA). Investigators will use a mean of data in three trials for analysis. b) 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 based on a recent systematic review in the form of mini-squatting exercise (up to 45O 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. To increase the intensity of exercise, elastic resistance bands will be used.
- Group (B) Patients in this group will receive the same program as group (A) plus core stability exercise and the principles of core 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.
- Statistical Analysis: Data management and analysis will be conducted using the statistical package for social studies (SPSS) version 22 for windows (IBM SPSS, Chicago, IL, USA). Investigators will conduct the 2X2 Mixed Design MANOVA test to compare the onset and duration of each muscle, pain intensity, and performance of functional activities between group A (traditional therapeutic knee rehabilitation) and group B (core stability) pre-treatment and post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, 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 core stability exercise.
| Arm | Type | Receives |
|---|---|---|
| group A | Other | Other: a traditional therapeutic knee rehabilitation programPatients in this group will receive a traditional therapeutic knee rehabilitation program based on a recent systematic review 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 using clamshell exercise . No emphasis will be placed on stabilizing the core musculature before initiating any of those exercises. |
| group B | Experimental | Other: a traditional therapeutic knee rehabilitation program, Other: core stability exercisePatients in this group will receive the same program as group (A) plus core stability exercise , but the principles of core 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. |
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 |
|---|---|---|
| a traditional therapeutic knee rehabilitation programmini-squatting exercise and clamshell exercise | Other | group A, group B |
| core stability exercisethe principles of core 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 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).
The change of EMG duration of multifidus,
Time frame: baseline and six 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 bio amplifier (WBA) system (Biomation, Almonte, Canada).
The change of EMG onset of transversus abdominus (TrA) muscle
Time frame: baseline and six weeks
investigators will collect the EMG activity of 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).
The change of EMG duration of transversus abdominus (TrA) muscle
Time frame: baseline and six weeks
investigators will collect the EMG activity of 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).
The change of EMG onset of gluteus medius (GM) muscle
Time frame: baseline and six weeks
investigators will collect the EMG activity of GM 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).
The change of EMG duration of gluteus medius (GM) muscle
Time frame: baseline and six weeks
investigators will collect the EMG activity of GM 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).
The change of EMG onset of vastus medialis obliqus (VMO) muscle
Time frame: baseline and six weeks
investigators will collect the EMG activity of VMO 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).
The change of EMG duration of vastus medialis obliqus (VMO) muscle
Time frame: baseline and six weeks
investigators will collect the EMG activity of VMO 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).
The change of EMG onset of vastus lateralis (VL) muscle
Time frame: baseline and six weeks
investigators will collect the EMG activity of VL 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).
The change of EMG duration of vastus lateralis (VL) muscle
Time frame: baseline and six weeks
investigators will collect the EMG activity of VL 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).
2 secondary outcomes
pain intensity
Time frame: baseline and six weeks
performance of functional activities
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 21 Sep 2022.
- 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?
A study testing a traditional therapeutic knee rehabilitation program and core stability exercise 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 21 Sep 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?
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 21 Sep 2022.