NCT07419750

Brief Summary

This study aims to examine the relationship between lower extremity muscle strength and balance and to compare these parameters between healthy individuals and individuals with lower extremity injuries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2026

Completed
Last Updated

March 24, 2026

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

December 19, 2025

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Static Balance Performance-ALFA Stabilometric Platform

    Static balance performance will be assessed using the ALFA Stabilometric Platform. A static balance performance score generated by the device software will be recorded separately for each side during the assessment. Higher scores indicate better static balance performance.

    Baseline

Secondary Outcomes (5)

  • Dynamic Balance Performance-ALFA Stabilometric Platform

    Baseline

  • Isokinetic Muscle Strength

    Baseline

  • Isokinetic Muscle Endurance

    Baseline

  • Pain Intensity

    Baseline

  • Kinesiophobia

    Baseline

Study Arms (3)

Healthy Controls

ACL Injury Group

CAI Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adults aged 18-40 years, including individuals with a unilateral anterior cruciate ligament injury, individuals with chronic ankle instability, and healthy controls. Participants with lower extremity injuries will have a confirmed diagnosis within the past 6 to 18 months. All participants will be able to speak, read, and understand Turkish and will voluntarily consent to participate in the study.

You may qualify if:

  • Anterior Cruciate Ligament (ACL) Injury Group:
  • Aged between 18 and 40 years
  • Diagnosed with a unilateral ACL injury 6 to 18 months prior to participation
  • Diagnosis confirmed by magnetic resonance imaging (MRI)
  • Ability to speak, read, and understand Turkish
  • Willingness to participate voluntarily in the study
  • Chronic Ankle Instability (CAI) Group:
  • Aged between 18 and 40 years
  • Diagnosed with chronic ankle instability due to recurrent ankle sprains 6 to 18 months prior to participation
  • History of at least two ankle sprains
  • Ongoing symptoms of functional ankle instability (e.g., episodes of giving way, feelings of instability)
  • Ability to speak, read, and understand Turkish
  • Willingness to participate voluntarily in the study
  • Healthy Control Group:
  • Aged between 18 and 40 years
  • +3 more criteria

You may not qualify if:

  • Presence of neurological, vestibular, or visual disorders that may affect balance
  • History of other orthopedic diseases or trauma
  • Presence of musculoskeletal disorders or cardiovascular comorbidities
  • History of physiotherapy, rehabilitation, or surgical intervention within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Zeytinburnu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 19, 2025

First Posted

February 19, 2026

Study Start

August 4, 2025

Primary Completion

February 2, 2026

Study Completion

March 2, 2026

Last Updated

March 24, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations