NCT06972186

Brief Summary

This study aims to investigate the effects of fatigue induced by isokinetic exercise on passive and active joint position sense in postmenopausal women diagnosed with knee osteoarthritis (gonarthrosis). A healthy control group matched for age and sex will also be included for comparative analysis. Participants will undergo proprioceptive assessments before and after an isokinetic fatigue protocol. We hypothesize that (1) fatigue will impair both passive and active joint position sense in patients with gonarthrosis, (2) active joint position sense will be more affected than passive sense, and (3) the deterioration in proprioception will be greater in the gonarthrosis group compared to healthy controls.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 6, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 6, 2025

Last Update Submit

May 6, 2025

Conditions

Keywords

osteoarthritis of kneepropripceptionisokinetic testgonarthritis

Outcome Measures

Primary Outcomes (1)

  • Joint Position Sense

    Passive Joint Position Sense Test: The knee joint will be passively moved to 45°, then returned to the starting position. The participant will be asked to perceive and replicate the same angle passively. The difference between the perceived and actual angles will be recorded. An isokinetic dynamometer will be used during this test. Active Joint Position Sense Test: With their eyes closed, participants will be asked to actively move their knee to 45° and then return to the starting position. They will then be asked to actively reproduce the same angle. The difference between the measured and target angles will be recorded. An isokinetic dynamometer will be used during this test.

    From enrollment to the end of intervention for 10 minutes

Study Arms (2)

Healthy Control

ACTIVE COMPARATOR

Age- and sex-matched postmenopausal women without knee pathology. Participants will perform the same passive and active joint position sense tests as the gonarthrosis group, before and after a control fatigue protocol using the Biodex system.

Diagnostic Test: Fatigue Protocol + Joint Position Sense Testing

Gonarthrosis Group

EXPERIMENTAL

Postmenopausal women aged 50-65 with Kellgren-Lawrence Grade 2-3 knee osteoarthritis. Participants will undergo an isokinetic fatigue protocol at 180°/s using a Biodex dynamometer. Passive and active joint position sense tests will be performed before and after fatigue.

Diagnostic Test: Fatigue Protocol + Joint Position Sense Testing

Interventions

Groups will undergo an isokinetic fatigue protocol at 180°/s using a Biodex dynamometer. Passive and active joint position sense tests will be performed before and after fatigue.

Gonarthrosis GroupHealthy Control

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, aged 50-65
  • Postmenopausal
  • Grade 2-3 knee osteoarthritis (Kellgren-Lawrence Scale) for OA group
  • No lower extremity surgery in the last 6 months
  • No neuromuscular or orthopedic condition affecting the lower extremities

You may not qualify if:

  • Severe balance disorders or vestibular disease
  • Bilateral knee prosthesis or severe osteoporosis
  • Lower extremity musculoskeletal injury in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

hatice sena cinarli, assistant professor

CONTACT

Ozan Uçar, Physical Therapist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Active Comparator
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 14, 2025

Study Start

June 1, 2025

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05