Clinical trial NCT05929261: Stress Response to Virtual Risky Movement Exposure and Kinesiophobia After Anterior Cruciate Ligament (ACL) Surgery
Official title: Stress Response to Virtual Exposure to Risky Movements After Anterior Cruciate Ligament (ACL) Rehabilitation and Its Relationship With Kinesiophobia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kinesiophobia
Anterior Cruciate Ligament Injuries
Keywords: Kinesiophobia
Anterior Cruciate Ligament Injuries
Virtual Reality
Stress
Athlete
Sports Medicine
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study group consists of subjects who had ACL reconstruction surgery and willing to return to sports activities.

Brief summary: In this study, patients who have completed their rehabilitation after Anterior Cruciate Ligament (ACL) reconstruction surgery will be examined with physiological stress response test while being exposed to risky athletic movements via virtual reality headsets. In the next, step patients' functional performance tests will be examined and their relation with stress responses will be examined.


Eligibility criteria: Inclusion Criteria for Study Group:

* 18 years or older
* Male gender
* Having history of isolated unilateral ACL reconstruction surgery
* Physician clearance for unrestricted physical activity after having at least 6-months of rehabilitation following surgery
* Willing to return to sports that require cutting and landing motions
* Not having any sports injuries past three months
* Not having any previous orthopaedic surgery other than ACL reconstruction surgery

Inclusion Criteria for Control Group:

* 18 years or older
* Male gender
* Playing sports that require cutting and landing motions
* Physician clearance for unrestricted physical activity
* Not having any sports injuries past three months
* Not having any previous orthopaedic surgery

Exclusion Criteria for Study Group:

* Having a reinjury during rehabilitation
* Having multiple ligament injuries before the surgery
* Diagnosed with knee osteoarthritis
* Diagnosed with knee cartilage injury
* Diagnosed with meniscus tear

Exclusion Criteria for Control Group:

* Diagnosed with ACL injury
* Diagnosed with knee osteoarthritis
* Diagnosed with knee cartilage injury
* Diagnosed with meniscus tear

Primary outcomes:
measure: Subjective Kinesiophobia Status - Anterior Cruciate Ligament - Return to Sport after Injury (ACL-RSI) scale
timeFrame: From 0 to 6 months
measure: Physiological Stress Responses - Heart Rate Variability (HRV) Metrics
timeFrame: From 0 to 6 months
measure: Physiological Stress Responses - Galvanic Skin Response (GSR) Metrics
timeFrame: From 0 to 6 months
measure: Functional Tests Landing Error Scoring System (LESS) score
timeFrame: From 0 to 6 months
measure: Functional Tests - Hop tests (single legged)
timeFrame: From 0 to 6 months
measure: Functional Tests - T-test
timeFrame: From 0 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine
Study officials:
References: