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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chondromalacia Patellae

Eligibility Criteria

35 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  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.

Exclusion Criteria:

  1. concomitant pain from tibiofemoral joint or other knee structures .
  2. current or previous pain in the hip, lumbar spine or foot that had lasted longer than 3 months and/or required intervention.
  3. a history of lower extremity, pelvis or spine fractures; spine, hip, knee or foot surgeries; hip or patellar subluxation/ dislocation.
  4. injury to any of knee ligaments or meniscus.
  5. systemic diseases (e.g. rheumatoid arthritis), neurological conditions or fibromyalgia .
  6. 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

    First Posted
    October 25, 2022
    Last Updated
    October 25, 2022
    Sponsor
    Cairo University
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    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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