NCT06538792

Brief Summary

Fear of re-injury after anterior cruciate ligament reconstruction surgery (ACLR) affects individuals' return to sports and physical activity negatively. The aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament reconstruction surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
0mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
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

Study Progress99%
Nov 2024Jun 2026

First Submitted

Initial submission to the registry

August 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

November 9, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

August 1, 2024

Last Update Submit

July 7, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Kinesiophobia

    The Tampa Kinesiophobia Scale consists of seventeen items. Scores obtained from the scale range from 17 to 68, with higher scores indicating greater severity of kinesiophobia.

    Baseline

  • Joint position sense

    Measurement of knee joint position sense by the active and passive repositioning technique with isokinetic dynamometer at 30˚ and 60˚.The deviation from the target angle is recorded in degrees. A high deviation from the target angle indicates a deficiency in proprioceptive sense.

    Baseline

  • Muscle strength

    Assessment for knee extensor and flexor muscles with isokinetic dynamometer at 60 º/sec and 240º/sec angular velocity. The peak torque value (Nm), which is measured by the device and indicates the maximum force the subject can reach, will be used in the assessment.

    Baseline

  • Dynamic stability

    The single leg dynamic stability test by the Biodex Balance System® (Biodex Medical Systems, Inc. USA). Low values of the stability index indicate better balance and stability, while higher scores indicate a lower ability to maintain postural stability.

    Baseline

Secondary Outcomes (1)

  • Return to sports after ACL injury

    Baseline

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients who have undergone ACL reconstruction surgery will be recruited from the Department of the Orthopaedics and Traumatology, Bezmialem Vakıf University Hospital.

You may qualify if:

  • Between the ages of 18-35
  • History of ACL reconstruction surgery at least 6 months ago

You may not qualify if:

  • History of previous lower extremity surgery
  • History of lower extremity injury within the last 6 months
  • Having a vestibular or neurologic pathology that would affect balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

  • Kubra Alpay, PhD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pysiotherapy and Rehabilitation Department

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 6, 2024

Study Start

November 9, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

July 10, 2025

Record last verified: 2025-07

Locations