Is Lower Limb Neuromotor Control Diverse in Females With PF OA Contrasted With Asymptomatic Controls

Chondromalacia Patellae Clinical Trial

Official title:

Is Lower Limb Neuromotor Control Diverse in Females With PF OA Contrasted With Asymptomatic Controls When Performing Stair Descent Task?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05407077
• Other study ID #: P.T.REC/012/003437
• Status: Completed
• Start date: June 30, 2022
• Est. completion date: January 2, 2023

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 consists of descending 2 steps. Patients should start descending the steps immediately in response to a command, at their normal speed with their affected limb. Healthy subjects should start descending stairs with their dominant limb . Before data acquisition, participants should perform one practice trial of stair descent to get familiarized with the task. Then the participants should 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 should use a mean of data in three trials for analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2, 2023
• Est. primary completion date: December 13, 2022
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• • Inclusion Criteria for PF OA group; patients will be included if they have

1. 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) .

2. 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 .,

3. 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:

1. concomitant pain from tibiofemoral joint or other knee structures . • Exclusion Criteria for Subjects from both groups:

1. current or previous pain in the hip, lumbar spine or foot that lasted longer than 3 months and/or required intervention.

2. a history of lower extremity, pelvis or spine fractures; spine, hip, knee or foot surgeries; hip or patellar subluxation/ dislocation.

3. injury to any of knee ligaments or meniscus.

4. 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.

Related Conditions & MeSH terms

• Cartilage Diseases
• Chondromalacia Patellae

Locations

Country	Name	City	State
Egypt	faculty of physical therapy, Cairo university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 bioamplifier (WBA) system (Biomation, Almonte, Canada).	from admission to discharge, up to two weeks
Primary	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 bioamplifier (WBA) system (Biomation, Almonte, Canada).	from admission to discharge, up to two weeks
Primary	The change of EMG duration of transversus abdominus	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).	from admission to discharge, up to two weeks
Primary	The change of EMG onset of transversus abdominus	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).	from admission to discharge, up to two weeks
Primary	The change of EMG onset of gluteus medius	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).	from admission to discharge, up to two weeks
Primary	The change of EMG duration of gluteus medius	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).	from admission to discharge, up to two weeks
Primary	The change of EMG onset of vastus medialis obliqus	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
Primary	The change of EMG duration of vastus medialis obliqus	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
Primary	The change of EMG duration of vastus lateralis	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
Primary	The change of EMG onset of vastus lateralis	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