NCT06319937

Brief Summary

Background: The aim of this study was to compare the knee and ankle muscle architecture and plantar pressure distribution differences in knee osteoarthritis (OA) women with healthy women. Methods: Fifty women with knee OA (Mean age=52.11±4.96 years, mean BMI=30.94±4.23 kg/m2) and fifty healthy women (Mean age= 50.93±3.78 years, mean BMI=29.06±4.82 kg/m2) were included in the study. Ultrasonography was used to evaluate Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Peroneus Longus (PL), Tibialis Anterior (TA), and Medial Gastrocnemius (MG) muscle thickness, pennation angle, fascicle length, and fat thickness. The plantar pressure distribution was evaluated using the Digital Biometry Scanning System and software (DIASU, Italy).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

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

January 26, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

January 26, 2024

Last Update Submit

March 13, 2024

Conditions

Keywords

knee osteoarthritisultrasonographykinesiophobiafunctional performancemusclesfoot

Outcome Measures

Primary Outcomes (3)

  • Muscle thickness

    Muscle thickness of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus. Muscle thickness of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus. Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The muscle thickness of each muscle were evaluated using B-Mode ultrasonography (Esaote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz)

    15 days

  • Pennation angle

    Pennation angle of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus. Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The pennation angle of each muscle were evaluated using B-Mode ultrasonography (Esaote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz)

    15 days

  • Fat thickness

    Fat thickness of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus. Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The fat thickness of each muscle were evaluated using B-Mode ultrasonography (Esaote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz)

    15 days

Secondary Outcomes (2)

  • Stair climbing test

    15 days

  • Sit-stand test

    15 days

Study Arms (1)

OA Group

EXPERIMENTAL

Knee OA were included in the study. All patients exhibited evident radiographic changes in either unilateral or bilateral knees, consistent with a diagnosis of osteoarthritis, and were classified as Kellgren Lawrence (K-L) grade 2.

Diagnostic Test: Ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

Ultrasound

OA Group

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 45-65 years
  • Activity-related knee pain
  • Morning knee stiffness for 30 min
  • Knee pain on most days for 3 months or more

You may not qualify if:

  • Having lower extremity surgery
  • Conditions that cause congenital or developmental diseases
  • The presence of systemic inflammatory arthritis
  • Polyneuropathy/lower extremity neuropathy, severe radiculopathy
  • Having undergone physical therapy, exercises or knee injections for the knee in the previous 6 months
  • Congenital foot deformity
  • BMI higher than 35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeFoot DeformitiesMuscle WeaknessKinesiophobia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesMuscular DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD, Prof.

Study Record Dates

First Submitted

January 26, 2024

First Posted

March 20, 2024

Study Start

April 1, 2024

Primary Completion

June 1, 2024

Study Completion

September 1, 2025

Last Updated

March 20, 2024

Record last verified: 2024-03