KinesiophobiaNCT05929261
Stress Response to Virtual Risky Movement Exposure and Kinesiophobia After Anterior Cruciate Ligament (ACL) Surgery
An observational study of Kinesiophobia and Anterior Cruciate Ligament Injuries, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Kinesiophobia, Anterior Cruciate Ligament Injuries
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study group consists of subjects who had ACL reconstruction surgery and willing to return to sports activities.
Who may be able to join
- 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
Show all 13Show fewer
- Not having any previous orthopaedic surgery other than ACL reconstruction surgery
- 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
Who cannot join
- 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
- Diagnosed with ACL injury
Show all 9Show fewer
- Diagnosed with knee osteoarthritis
- Diagnosed with knee cartilage injury
- Diagnosed with meniscus tear
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University Faculty of Medicine
Izmir, 35100
Ogün Köyağasıoğlu, 02323902378, ogunkoyagasioglu@gmail.com
About this study
Official title: Stress Response to Virtual Exposure to Risky Movements After Anterior Cruciate Ligament (ACL) Rehabilitation and Its Relationship With Kinesiophobia
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.
- Conditions
- Kinesiophobia, Anterior Cruciate Ligament Injuries
- Keywords
- Kinesiophobia, Anterior Cruciate Ligament Injuries, Virtual Reality, Stress, Athlete, Sports Medicine
- Medical subject headings
- Kinesiophobia, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Study group will be examined for outcome measurements. | |
| Control Group | Control group will be examined for outcome measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Kinesiophobia Status - Anterior Cruciate Ligament - Return to Sport after Injury (ACL-RSI) scale
ACL-RSI scale evaluates psychological readiness to return to sports participation after ACL reconstruction and has items related to fear of reinjury/accidental injury during sport activities.
The scale contains 12 questions and each question is scored from 0 to 100 in 10-point increments according to the visual analog scale. The scale score is calculated by adding the scores from all 12 questions and dividing by 12. A high score on the scale indicates a positive psychological response.
Measured: From 0 to 6 months
Physiological Stress Responses - Heart Rate Variability (HRV) Metrics
Metrics will be measured with Shimmer 3 GSR Development and Consensys GSR Development Kit. Low Frequency (LF), High Frequency (HF), Low Frequency to High Frequency ratio (LF/HF), root mean square of successive differences (RMMSD) will be measured from participants while watching stress evoking videos. Metrics will be measured according to the Task Force guidelines in 1996. RMSSD reflects the integrity of vagus nerve-mediated autonomic control of the heart, HF reflects parasympathetic activity, and LF is proportional to sympathetic activity but influenced by parasympathetic tone. LF/HF reflects sympathetic activity dominancy over parasympathetic activity.
Measured: From 0 to 6 months
Physiological Stress Responses - Galvanic Skin Response (GSR) Metrics
Metrics will be measured with Shimmer 3 GSR Development and Consensys GSR Development Kit. Skin conductance response (SCR) will be measured from participants while watching stress evoking videos. SCR is the measurement of the electrical conductivity of the skin and represents the activation of sweat glands in response to a particular stressor stimuli.
Measured: From 0 to 6 months
Functional Tests Landing Error Scoring System (LESS) score
Participants will be tested for their landing with a standardized jump-landing from a box task. Subjects will jump down from the box and land on the ground and then immediately jump vertically upward as high as possible. We will rate for every participant by observing in both the sagittal and the frontal plane of jump- landing technique while the subject was in contact with the ground after landing from the box.
Scoring will be made as "No" (0 points) and "Yes" (1 point) for Items 1-15. For Item16, it will be evaluated as "Excellent" (0 points), "Average" (1 point) and "Hard" (2 points). For item 17, "Excellent" (0 points), "Average" (1 point) and "Bad" (2 points). The total score of 17 items will be evaluated. The higher the score obtained from the test result, the worse the jump landing. LESS scores will be interpreted in four different categories: excellent (LESS score <4), good (4<LESS score ≤5), moderate (5<LESS score ≤6), and poor (LESS score >6).
Measured: From 0 to 6 months
Functional Tests - Hop tests (single legged)
Participants will be tested for leg hop tests which described in the literature by Ross et al. 2002. >10% difference between tested legs will be considered as asymmetry.
Single Hop for Distance. Subjects will be instructed to hop as far as possible forward and land on the same leg. The distance from the starting line to the point where the subject is landed will be measured.
Triple Hop for Distance. Subjects will be instructed to take 3 maximal hops forward with the designated leg. The distance from the starting line to the point where the subject is landed will be measured.
Crossover Hop for Distance. Subjects will be instructed to take 3 maximal hops while crossing over a line each time. The distance from the starting line to the point where the subject is landed will be measured.
Six Meter Hop for Time. Subjects will be instructed to hop 6m distance as quickly as possible with the designated leg. Time will be measured from start to the time the subject crossed the finish line.
Measured: From 0 to 6 months
Functional Tests - T-test
For each participant, a running t test will be performed, which will evaluate their agility during running with changes of direction. Participants will be asked to run forward for 10 m, then change to side-steps to the right for 5 m, then 10 m of side-steps to the left, followed by 5 m of side- steps to the right, ending with 10 m of backwards running. Three repetitions will be performed at maximum speed and the average time for the three repetitions will be calculated.
Completing the test in less than 11 seconds will be classified as high agility, and finishing in 11 seconds or more will be classified as low agility.
Measured: From 0 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start15 Jul 2023
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KinesiophobiaStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ogun Koyagasioglu, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929261
- Sponsor's protocol ID
- 22-12.2Tl31
- Status last verified
- Nov 2023
- First submitted
- 15 Jun 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Response to Virtual Exposure to Risky Movements After Anterior Cruciate Ligament (ACL) Rehabilitation and Its Relationship With Kinesiophobia
- ClinicalTrials.gov ID
- NCT05929261
- Acronym / sponsor ID
- 22-12.2Tl31
- Conditions
- Kinesiophobia, Anterior Cruciate Ligament Injuries
- Keywords
- Kinesiophobia, Anterior Cruciate Ligament Injuries, Virtual Reality, Stress, Athlete, Sports Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Study group will be examined for outcome measurements. |
| Control Group | – | –Control group will be examined for outcome measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study group consists of subjects who had ACL reconstruction surgery and willing to return to sports activities.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective Kinesiophobia Status - Anterior Cruciate Ligament - Return to Sport after Injury (ACL-RSI) scale
Time frame: From 0 to 6 months
ACL-RSI scale evaluates psychological readiness to return to sports participation after ACL reconstruction and has items related to fear of reinjury/accidental injury during sport activities. The scale contains 12 questions and each question is scored from 0 to 100 in 10-point increments according to the visual analog scale. The scale score is calculated by adding the scores from all 12 questions and dividing by 12. A high score on the scale indicates a positive psychological response.
Physiological Stress Responses - Heart Rate Variability (HRV) Metrics
Time frame: From 0 to 6 months
Metrics will be measured with Shimmer 3 GSR Development and Consensys GSR Development Kit. Low Frequency (LF), High Frequency (HF), Low Frequency to High Frequency ratio (LF/HF), root mean square of successive differences (RMMSD) will be measured from participants while watching stress evoking videos. Metrics will be measured according to the Task Force guidelines in 1996. RMSSD reflects the integrity of vagus nerve-mediated autonomic control of the heart, HF reflects parasympathetic activity, and LF is proportional to sympathetic activity but influenced by parasympathetic tone. LF/HF reflects sympathetic activity dominancy over parasympathetic activity.
Physiological Stress Responses - Galvanic Skin Response (GSR) Metrics
Time frame: From 0 to 6 months
Metrics will be measured with Shimmer 3 GSR Development and Consensys GSR Development Kit. Skin conductance response (SCR) will be measured from participants while watching stress evoking videos. SCR is the measurement of the electrical conductivity of the skin and represents the activation of sweat glands in response to a particular stressor stimuli.
Functional Tests Landing Error Scoring System (LESS) score
Time frame: From 0 to 6 months
Participants will be tested for their landing with a standardized jump-landing from a box task. Subjects will jump down from the box and land on the ground and then immediately jump vertically upward as high as possible. We will rate for every participant by observing in both the sagittal and the frontal plane of jump- landing technique while the subject was in contact with the ground after landing from the box. Scoring will be made as "No" (0 points) and "Yes" (1 point) for Items 1-15. For Item16, it will be evaluated as "Excellent" (0 points), "Average" (1 point) and "Hard" (2 points). For item 17, "Excellent" (0 points), "Average" (1 point) and "Bad" (2 points). The total score of 17 items will be evaluated. The higher the score obtained from the test result, the worse the jump landing. LESS scores will be interpreted in four different categories: excellent (LESS score <4), good (4<LESS score ≤5), moderate (5<LESS score ≤6), and poor (LESS score >6).
Functional Tests - Hop tests (single legged)
Time frame: From 0 to 6 months
Participants will be tested for leg hop tests which described in the literature by Ross et al. 2002. >10% difference between tested legs will be considered as asymmetry. Single Hop for Distance. Subjects will be instructed to hop as far as possible forward and land on the same leg. The distance from the starting line to the point where the subject is landed will be measured. Triple Hop for Distance. Subjects will be instructed to take 3 maximal hops forward with the designated leg. The distance from the starting line to the point where the subject is landed will be measured. Crossover Hop for Distance. Subjects will be instructed to take 3 maximal hops while crossing over a line each time. The distance from the starting line to the point where the subject is landed will be measured. Six Meter Hop for Time. Subjects will be instructed to hop 6m distance as quickly as possible with the designated leg. Time will be measured from start to the time the subject crossed the finish line.
Functional Tests - T-test
Time frame: From 0 to 6 months
For each participant, a running t test will be performed, which will evaluate their agility during running with changes of direction. Participants will be asked to run forward for 10 m, then change to side-steps to the right for 5 m, then 10 m of side-steps to the left, followed by 5 m of side- steps to the right, ending with 10 m of backwards running. Three repetitions will be performed at maximum speed and the average time for the three repetitions will be calculated. Completing the test in less than 11 seconds will be classified as high agility, and finishing in 11 seconds or more will be classified as low agility.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kinesiophobia and Anterior Cruciate Ligament Injuries, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ogun Koyagasioglu, MD (+90 232 390 23 78, ogunkoyagasioglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Kinesiophobia Status - Anterior Cruciate Ligament - Return to Sport after Injury (ACL-RSI) scale (time frame: From 0 to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.