- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05597670
Effect of Proximal Stabilization on Recruitment of the Core & Vasti in Patellofemoral Arthritis During Descending Stairs
Effect of Proximal Stabilization on Recruitment of the Core & Vasti in Patients With Patellofemoral Arthritis as They Descend Stairs
Study Overview
Status
Conditions
Intervention / 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.
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 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt, 11432
- Faculty of physical therapy, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: group A
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
|
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
|
|
Experimental: group B
Patients in this group will receive the same program as group (A) plus proximal stabilization exercise
|
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline and six weeks
|
|
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
|
baseline and six weeks
|
|
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
|
baseline and six weeks
|
|
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
|
baseline and six weeks
|
|
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
|
baseline and six weeks
|
|
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
|
baseline and six weeks
|
|
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
|
baseline and six weeks
|
|
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
|
baseline and six weeks
|
|
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
|
baseline and six weeks
|
|
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
|
baseline and six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
kinesiophobia
Time Frame: baseline and six weeks
|
patients will respond to the questions of the Tempa scale
|
baseline and six weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003438
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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