NCT05407077

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

June 2, 2022

Last Update Submit

August 31, 2023

Conditions

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

females with isolated patellofemoral arthritis

those with anterior knee pain

healthy females

those without anterior knee pain

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • \. no history of knee pathology or pain with any of the provocative activities which were mentioned above

You may not qualify if:

  • <!-- -->
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Chondromalacia Patellae

Condition Hierarchy (Ancestors)

Cartilage DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 7, 2022

Study Start

June 30, 2022

Primary Completion

December 13, 2022

Study Completion

January 2, 2023

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations