- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05407077
Is Lower Limb Neuromotor Control Diverse in Females With PF OA Contrasted With Asymptomatic Controls
Is Lower Limb Neuromotor Control Diverse in Females With PF OA Contrasted With Asymptomatic Controls When Performing Stair Descent Task?
Objective: to investigate whether females with PF OA descend stairs with different muscular recruitment strategies contrasted with similar aged healthy females.
Methods: An observational comparative study will be conducted with thirty females with PF OA and 10 healthy ones. The onset times and electromyography (EMG) duration of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti muscles will be measured by quantitative EMG during stair descent task. hypothesis: Investigators hypothesize that there won't be a significant difference between females with PF OA and their matched healthy group regarding the onset times and duration of vastus medialis obliqus (VMO), vastus lateralis (VL), gluteus medius (GM), multifidus, and transversus abdominus (TrA), during stair descent task.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Giza, Egypt, 11432
- Faculty of physical therapy, Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
• Inclusion Criteria for PF OA group; patients will be included if they have
- 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.
Inclusion Criteria for Healthy control subjects :
1. no history of knee pathology or pain with any of the provocative activities which were mentioned above
Exclusion Criteria:
• Exclusion Criteria for Patients in the PF OA group:
- concomitant pain from tibiofemoral joint or other knee structures . • Exclusion Criteria for Subjects from both groups:
- current or previous pain in the hip, lumbar spine or foot that 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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females with isolated patellofemoral arthritis
those with anterior knee pain
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healthy females
those without anterior knee pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The change of EMG onset of multifidus
Time Frame: from admission to discharge, up to two weeks
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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 bioamplifier (WBA) system (Biomation, Almonte, Canada).
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from admission to discharge, up to two weeks
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The change of EMG duration of multifidus
Time Frame: from admission to discharge, up to two 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 bioamplifier (WBA) system (Biomation, Almonte, Canada).
|
from admission to discharge, up to two weeks
|
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The change of EMG duration of transversus abdominus
Time Frame: from admission to discharge, up to two weeks
|
investigators will collect the EMG activity of transversus abdominus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
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from admission to discharge, up to two weeks
|
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The change of EMG onset of transversus abdominus
Time Frame: from admission to discharge, up to two weeks
|
investigators will collect the EMG activity of transversus abdominus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
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from admission to discharge, up to two weeks
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The change of EMG onset of gluteus medius
Time Frame: from admission to discharge, up to two weeks
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investigators will collect the EMG activity of gluteus medius using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
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from admission to discharge, up to two weeks
|
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The change of EMG duration of gluteus medius
Time Frame: from admission to discharge, up to two weeks
|
investigators will collect the EMG activity of gluteus medius using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
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from admission to discharge, up to two weeks
|
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The change of EMG onset of vastus medialis obliqus
Time Frame: from admission to discharge, up to two weeks
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investigators will collect the EMG activity of vastus medialis obliqus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
|
from admission to discharge, up to two weeks
|
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The change of EMG duration of vastus medialis obliqus
Time Frame: from admission to discharge, up to two weeks
|
investigators will collect the EMG activity of vastus medialis obliqus using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
|
from admission to discharge, up to two weeks
|
|
The change of EMG duration of vastus lateralis
Time Frame: from admission to discharge, up to two weeks
|
investigators will collect the EMG activity of vastus lateralis using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
|
from admission to discharge, up to two weeks
|
|
The change of EMG onset of vastus lateralis
Time Frame: from admission to discharge, up to two weeks
|
investigators will collect the EMG activity of vastus lateralis using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bioamplifier (WBA) system (Biomation, Almonte, Canada).
|
from admission to discharge, up to two 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 (Actual)
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/012/003437
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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