NCT05870033

Brief Summary

Muscle activity, as a possible fundamental cause of functional limitation, has been extensively investigated in knee osteoarthritis (KOA). Many trials investigated muscle activity during dynamic movements and functional tasks in KOA. In addition, gender-related differences has been also investigated during functional movements in KOA. However, no trial investigated gender-related differences in muscle activation during static movement in KOA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

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

Study Start

First participant enrolled

April 30, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

May 2, 2023

Last Update Submit

November 30, 2023

Conditions

Outcome Measures

Primary Outcomes (13)

  • Patients' baseline state

    Measurement of patients' pain, stiffness and functional state based on WOMAC

    within 1 day

  • Patients' baseline pain

    Measurement of patients' pain based on Numeric Pain Rating Scale

    within 1 day

  • Patients' baseline knee flexion

    Measurement of patients' active knee flexion in supine

    within 1 day

  • Patients' baseline knee flexion in standing position

    Measurement of patients' active knee flexion during weight-bearing

    within 1 day

  • Muscle strength of m. quadriceps femoris

    Measurement of muscle strength of m. quadriceps femoris in 0, 35 and 60 degree

    within 1 day

  • Muscle strength of hamstring muscles

    Measurement of muscle strength of m. semitendinosus, semimembranosus and biceps femoris in 0, 35 and 60 degree

    within 1 day

  • Muscle activation in 30 degree static knee flexion

    EMG measurement of muscle activation during 2-leg 30 degree static knee flexion

    within 1 day

  • Muscle activation in 60 degree static knee flexion

    EMG measurement of muscle activation during 2-leg 60 degree static knee flexion

    within 1 day

  • Muscle activation during stepping up a stair

    EMG measurement of muscle activation during stepping up on a stair

    within 1 day

  • Muscle activation during stepping down a stair

    EMG measurement of muscle activation during stepping down from a stair

    within 1 day

  • Muscle activation during stepping down side-ways a stair with affected leg

    EMG measurement of muscle activation during stepping down side-ways a stair with affected leg

    within 1 day

  • Muscle activation during stepping down side-ways a stair with opposite leg

    EMG measurement of muscle activation during stepping down side-ways a stair with opposite leg

    within 1 day

  • Muscle activation in one-leg standing position

    EMG measurement of muscle activation in one-leg standing position

    within 1 day

Study Arms (2)

Men group

Muscle activity amongst men with KOA

Device: Electromyography (EMG) measurement

Women group

Muscle activity amongst women with KOA

Device: Electromyography (EMG) measurement

Interventions

Electromyography (EMG) measurement of m. quadriceps femoris and semitendinosus muscle during static functional tasks

Men groupWomen group

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with radiologically diagnosed KOA

You may qualify if:

  • radiologically diagnosed KOA based on the Kellgren-Lawrence grading system 1-3,
  • age above 60 years
  • at least 60° active knee flexion
  • sufficient mental status

You may not qualify if:

  • acute inflammation of the knee
  • intraarticular injections within the last 3 months
  • total knee replacement in the opposite side
  • class II obesity (body mass index, BMI\>35kg/m2)
  • severe degenerative lumbar spine disease (e.g., spondylolisthesis)
  • systemic inflammatory arthritic or neurological condition
  • conservative intervention attendance within 6 months
  • contraindication to conservative therapy and manual therapy
  • unstable heart condition
  • complex regional pain syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pécs

Pécs, Baranya, 7621, Hungary

Location

Related Publications (3)

  • Al Amer HS, Sabbahi MA, Alrowayeh HN, Bryan WJ, Olson SL. Electromyographic activity of quadriceps muscle during sit-to-stand in patients with unilateral knee osteoarthritis. BMC Res Notes. 2018 Jun 5;11(1):356. doi: 10.1186/s13104-018-3464-9.

    PMID: 29871669BACKGROUND
  • Bouchouras G, Sofianidis G, Patsika G, Kellis E, Hatzitaki V. Women with knee osteoarthritis increase knee muscle co-contraction to perform stand to sit. Aging Clin Exp Res. 2020 Apr;32(4):655-662. doi: 10.1007/s40520-019-01245-z. Epub 2019 Jun 15.

    PMID: 31203528BACKGROUND
  • Smith SL, Woodburn J, Steultjens MPM. Sex- and osteoarthritis-related differences in muscle co-activation during weight-bearing tasks. Gait Posture. 2020 Jun;79:117-125. doi: 10.1016/j.gaitpost.2020.04.019. Epub 2020 Apr 27.

    PMID: 32402893BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

ElectromyographyWeights and Measures

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyographyInvestigative Techniques

Study Officials

  • Csaba Melczer, Physiother.

    University of Pecs

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 23, 2023

Study Start

April 30, 2023

Primary Completion

November 1, 2023

Study Completion

November 30, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations