Effect of Proximal Stabilization on Recruitment of the Core & Vasti in Patellofemoral Arthritis During Descending Stairs
Primary Purpose
Chondromalacia Patellae
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
traditional knee rehabilitation program
proximal stabilization
Sponsored by
About this trial
This is an interventional treatment trial for Chondromalacia Patellae
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
group A
group B
Arm Description
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 the same program as group (A) plus proximal stabilization exercise
Outcomes
Primary Outcome Measures
The change of EMG onset of multifidus
investigators will collect the EMG activity of multifidus by electromyography (EMG) using surface electrodes
The change of EMG duration of multifidus
investigators will collect the EMG activity of multifidus by electromyography (EMG) using surface electrodes
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
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
The change of EMG onset of vastus lateralis
investigators will collect the EMG activity of vastus lateralis by electromyography (EMG) using surface electrodes
The change of EMG duration of vastus lateralis
investigators will collect the EMG activity of vastus lateralis by electromyography (EMG) using surface electrodes
The change of EMG duration of gluteus medius
investigators will collect the EMG activity of gluteus medius by electromyography (EMG) using surface electrodes
The change of EMG onset of gluteus medius
investigators will collect the EMG activity of gluteus medius by electromyography (EMG) using surface electrodes
The change of EMG onset of transversus abdominus
investigators will collect the EMG activity of transversus abdominus by electromyography (EMG) using surface electrodes
The change of EMG duration of transversus abdominus
investigators will collect the EMG activity of transversus abdominus by electromyography (EMG) using surface electrodes
Secondary Outcome Measures
kinesiophobia
patients will respond to the questions of the Tempa scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05597670
Brief Title
Effect of Proximal Stabilization on Recruitment of the Core & Vasti in Patellofemoral Arthritis During Descending Stairs
Official Title
Effect of Proximal Stabilization on Recruitment of the Core & Vasti in Patients With Patellofemoral Arthritis as They Descend Stairs
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 . 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chondromalacia Patellae
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Other
Arm Description
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
Arm Title
group B
Arm Type
Experimental
Arm Description
Patients in this group will receive the same program as group (A) plus proximal stabilization exercise
Intervention Type
Other
Intervention Name(s)
traditional knee rehabilitation program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
proximal stabilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of EMG onset of multifidus
Description
investigators will collect the EMG activity of multifidus by electromyography (EMG) using surface electrodes
Time Frame
baseline and six weeks
Title
The change of EMG duration of multifidus
Description
investigators will collect the EMG activity of multifidus by electromyography (EMG) using surface electrodes
Time Frame
baseline and six weeks
Title
The change of EMG duration of vastus medialis obliqus
Description
investigators will collect the EMG activity of vastus medialis obliqus by electromyography (EMG) using surface electrodes
Time Frame
baseline and six weeks
Title
The change of EMG onset of vastus medialis obliqus
Description
investigators will collect the EMG activity of vastus medialis obliqus by electromyography (EMG) using surface electrodes
Time Frame
baseline and six weeks
Title
The change of EMG onset of vastus lateralis
Description
investigators will collect the EMG activity of vastus lateralis by electromyography (EMG) using surface electrodes
Time Frame
baseline and six weeks
Title
The change of EMG duration of vastus lateralis
Description
investigators will collect the EMG activity of vastus lateralis by electromyography (EMG) using surface electrodes
Time Frame
baseline and six weeks
Title
The change of EMG duration of gluteus medius
Description
investigators will collect the EMG activity of gluteus medius by electromyography (EMG) using surface electrodes
Time Frame
baseline and six weeks
Title
The change of EMG onset of gluteus medius
Description
investigators will collect the EMG activity of gluteus medius by electromyography (EMG) using surface electrodes
Time Frame
baseline and six weeks
Title
The change of EMG onset of transversus abdominus
Description
investigators will collect the EMG activity of transversus abdominus by electromyography (EMG) using surface electrodes
Time Frame
baseline and six weeks
Title
The change of EMG duration of transversus abdominus
Description
investigators will collect the EMG activity of transversus abdominus by electromyography (EMG) using surface electrodes
Time Frame
baseline and six weeks
Secondary Outcome Measure Information:
Title
kinesiophobia
Description
patients will respond to the questions of the Tempa scale
Time Frame
baseline and six weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Effect of Proximal Stabilization on Recruitment of the Core & Vasti in Patellofemoral Arthritis During Descending Stairs
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