NCT07261540

Brief Summary

Osteoarthritis (OA) is a degenerative joint disease that primarily affects the knees and becomes more prevalent with age. In individuals over 50, particularly those with bilateral knee osteoarthritis, it leads to chronic pain, limited mobility, and functional decline. This condition worsens due to muscle strength imbalances, especially in the quadriceps and hamstrings. These imbalances are triggered by pain, joint instability, and cartilage damage, which negatively impact muscle strength and coordination. In women, these asymmetries are more pronounced, increasing the risk of functional decline. Recent studies highlight the significant role of strength asymmetry in functional limitations, affecting balance, gait, and daily activities. This study aims to investigate the impact of bilateral quadriceps and hamstring strength asymmetries on dynamic balance, gait efficiency, and functional mobility in older women with bilateral knee osteoarthritis. The study aims to examine the effects of bilateral strength asymmetries in the knee extensors and flexors on dynamic balance, gait efficiency, and overall mobility in older women with bilateral knee osteoarthritis. We hypothesize that greater strength asymmetry will be associated with impaired dynamic balance, reduced gait efficiency, and decreased functional mobility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2025

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
Last Updated

December 3, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

November 22, 2025

Last Update Submit

November 22, 2025

Conditions

Keywords

knee osteoarthristisPostmenopausal womenmuscle strenghtisokinetic testFunctional Performance

Outcome Measures

Primary Outcomes (2)

  • Isokinetic Strength Testing

    Bilateral knee strength asymmetry was assessed using a Biodex System 4 Pro isokinetic dynamometer (Biodex Medical Systems, USA). Participants were securely positioned, and knee extensor and flexor strength were measured at angular velocities of 120°/s and 180°/s. Each participant performed five maximal concentric contractions per limb, with the highest peak torque values recorded. Higher asymmetry values indicated greater strength imbalances between limbs

    From enrollment to the end of evaluation in 1 hour

  • Functional Mobility

    The 30-second Sit-to-Stand test was used to assess lower limb functional strength and endurance. Participants were instructed to stand up and sit down as many times as possible in 30 seconds from a standard chair (seat height: 46 cm) without using their arms. The total number of completed repetitions was recorded. A lower Sit-to-Stand score indicates reduced quadriceps endurance, decreased functional independence, and a higher fall risk in older adults.

    From enrollment to the end of evaluation in 1 hour

Secondary Outcomes (3)

  • Pain Assessment

    From enrollment to the end of evaluation in 1 hour

  • Dynamic Balance Measurement

    From enrollment to the end of evaluation in 1 hour

  • Gait Speed

    From enrollment to the end of evaluation in 1 hour

Study Arms (1)

Study Group

Patients with bilateral knee osteoarthritis who met the inclusion criteria underwent a single laboratory assessment involving isokinetic strength testing, pain evaluation, dynamic balance assessment, and functional mobility tests. Isokinetic strength testing was performed on both knees of the patients.All assessments took 1 hour in total for each patient.

Other: Isokinetic Strength Testing

Interventions

Bilateral knee strength asymmetry was assessed using a Biodex System 4 Pro isokinetic dynamometer (Biodex Medical Systems, USA). Participants were securely positioned, and knee extensor and flexor strength were measured at angular velocities of 120°/s and 180°/s. Each participant performed five maximal concentric contractions per limb, with the highest peak torque values recorded.

Also known as: Pain Assessment, Dynamic Balance Measurement, Functional Mobility, Gait Speed
Study Group

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This cross-sectional observational study investigates the impact of bilateral isokinetic strength asymmetry on dynamic balance and gait speed in women with bilateral knee osteoarthritis. Participants were recruited from Inonu University Faculty of Medicine Research Hospital Physical Therapy and Rehabilitation Department with eligibility determined based on clinical and radiographic assessments.

You may qualify if:

  • women gender
  • aged 50 years or older
  • diagnosed with bilateral knee osteoarthritis (Kellgren-Lawrence grade II-III),
  • capable of independent walking without assistive devices.

You may not qualify if:

  • severe knee osteoarthritis requiring total knee arthroplasty
  • neurological conditions affecting gait or balance
  • severe musculoskeletal disorders
  • uncontrolled systemic diseases
  • cognitive impairments (Mini-Mental State Examination \< 24)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli Health and Technology University

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Walking Speed

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisWalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sema Aktürk, MD Professor

    Inonu University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Professor

Study Record Dates

First Submitted

November 22, 2025

First Posted

December 3, 2025

Study Start

April 1, 2025

Primary Completion

May 5, 2025

Study Completion

June 1, 2025

Last Updated

December 3, 2025

Record last verified: 2025-05

Locations