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CompletedNCT04669834Updated Sep 21, 2022

Effect of Core Stability Exercise on Isolated Patellofemoral Osteoarthritis.

An interventional study of a traditional therapeutic knee rehabilitation program and core stability exercise in Chondromalacia Patellae, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 35 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
35 Years to 55 Years
Sex
Female
01

Study summary

Purpose: to investigate the effect of core stability on PF OA. Methods: Thirty-one females 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 core stability exercise. All patients will be evaluated for pain, functional performance, and muscular recruitment strategies (onset and duration) of multifidus, transversus abdominus (TrA), gluteus medius (GM), and vasti measured by quantitative Electromyography during stair ascent. pre and post-treatment.

Read the 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 f in the following manner:

  1. Patients will be asked to respond to the questions of the Kujala scale.
  2. The eleven-point numerical rating scale will be used to measure pain severity
  3. 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 will consist of ascending 2 steps (each step will be 40 cm in width, 20 cm in height, without handrails. The depth of the first and second steps will be 30 cm and 40 cm, respectively) . Participants will be asked to stand on the floor confronting the stairs and 20 cm away from the edge of the initial step.

    The stair ascent task will be performed barefooted while arms hanged at the side of the body. Patients will start ascending the steps immediately in response to a command, at their normal speed with their affected limb. Investigators aren't going to control the speed of stair ascent, because controlling the timing of stair-stepping can alter the electromyographic signal as shown earlier for gait in asymptomatic subjects. Before data acquisition, participants will be asked to perform one practice trial of stair ascent 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 (Math Works, Natick, Massachusetts, USA). 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 based on a recent systematic review in the form of mini-squatting exercise (up to 45O 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.

    To increase the intensity of exercise, elastic resistance bands will be used.

    • Group (B) Patients in this group will receive the same program as group (A) plus core stability exercise and the principles of core 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.

    c) Statistical Analysis: Data management and analysis will be conducted using the statistical package for social studies (SPSS) version 22 for windows (IBM SPSS, Chicago, IL, USA). Investigators will conduct the 2X2 Mixed Design MANOVA test to compare the onset and duration of each muscle, pain intensity, and performance of functional activities between group A (traditional therapeutic knee rehabilitation) and group B (core stability) pre-treatment and post-treatment.

02

Conditions studied

  • Chondromalacia Patellae
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 31 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: patients included if they had

  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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
31 participants (actual)

Study arms

  • Other
    group A

    Patients in this group will receive a traditional therapeutic knee rehabilitation program based on a recent systematic review 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 using clamshell exercise . No emphasis will be placed on stabilizing the core musculature before initiating any of those exercises.

    Other: a traditional therapeutic knee rehabilitation program

  • Experimental
    group B

    Patients in this group will receive the same program as group (A) plus core stability exercise , but the principles of core 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.

    Other: a traditional therapeutic knee rehabilitation program · Other: core stability exercise

Interventions

  • Othera traditional therapeutic knee rehabilitation program

    mini-squatting exercise and clamshell exercise

  • Othercore stability exercise

    the principles of core 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.

06

What researchers measure

Primary outcomes

  1. 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 bio amplifier (WBA) system (Biomation, Almonte, Canada).

    Time frame: baseline and six weeks

  2. 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 bio amplifier (WBA) system (Biomation, Almonte, Canada).

    Time frame: baseline and six weeks

  3. The change of EMG onset of transversus abdominus (TrA) muscle

    investigators will collect the EMG activity of TrA using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada).

    Time frame: baseline and six weeks

  4. The change of EMG duration of transversus abdominus (TrA) muscle

    investigators will collect the EMG activity of TrA using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada).

    Time frame: baseline and six weeks

  5. The change of EMG onset of gluteus medius (GM) muscle

    investigators will collect the EMG activity of GM using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada).

    Time frame: baseline and six weeks

  6. The change of EMG duration of gluteus medius (GM) muscle

    investigators will collect the EMG activity of GM using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada).

    Time frame: baseline and six weeks

  7. The change of EMG onset of vastus medialis obliqus (VMO) muscle

    investigators will collect the EMG activity of VMO using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada).

    Time frame: baseline and six weeks

  8. The change of EMG duration of vastus medialis obliqus (VMO) muscle

    investigators will collect the EMG activity of VMO using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada).

    Time frame: baseline and six weeks

  9. The change of EMG onset of vastus lateralis (VL) muscle

    investigators will collect the EMG activity of VL using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada).

    Time frame: baseline and six weeks

  10. The change of EMG duration of vastus lateralis (VL) muscle

    investigators will collect the EMG activity of VL using bipolar Ag-AgCl disposable surface electrodes (Better signal solution medical supply Co., limited, Zhongshan, China) and eight channels high-resolution wireless bio amplifier (WBA) system (Biomation, Almonte, Canada).

    Time frame: baseline and six weeks

Secondary outcomes

  1. pain intensity

    The eleven-point numerical rating scale will be used to measure pain severity for patients.where the endpoints are the extremes of no pain and pain as bad as it could be or worst pain. increasing the value means more intense pain.

    Time frame: baseline and six weeks

  2. performance of functional activities

    kujala scale will be used to evaluate the performance of functional activities. This questionnaire includes 13 questions and the scores range from 0 to 100, where 100 indicates the highest efficiency of the knee and 0 indicates the highest disability.

    Time frame: baseline and six weeks

07

Study locations

1 site
  • faculty of physical therapy, Cairo university
    Giza, 11432, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04669834
Lead sponsor
Cairo University
Responsible party
Jilan Adel yousef (assistant lecturer, Cairo University) — Principal investigator
First posted
Dec 17, 2020
Start date
Nov 19, 2020
Primary completion
Aug 20, 2022
Completion
Aug 28, 2022
Last update
Sep 21, 2022

Study contacts

Aladdin A. balbaa, professor
study director · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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