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

August 31, 2023 updated by: Jilan Adel yousef, Cairo University

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

Completed

Detailed 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.

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Giza, Egypt, 11432
        • Faculty of physical therapy, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited from the Outpatient Clinic of Kasr Al-Ainy Hospital and the Faculty of Physical Therapy, Cairo University as well. However, control subjects will be recruited via advertising in the local community.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
females with isolated patellofemoral arthritis
those with anterior knee pain
healthy females
those without anterior knee pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of EMG onset 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
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
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).
from admission to discharge, up to two weeks
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).
from admission to discharge, up to two weeks
The change of EMG onset 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).
from admission to discharge, up to two weeks
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).
from admission to discharge, up to two weeks
The change of EMG onset 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 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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Actual)

December 13, 2022

Study Completion (Actual)

January 2, 2023

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • P.T.REC/012/003437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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