Anterior Cruciate Ligament RuptureNCT06752109
The Effect of Subtalar Joint Antipronation Taping on the Dynamic Knee Valgus in Female Volleyball Players with Low Medial Arch
A study testing Antipronation Taping in people with Anterior Cruciate Ligament Rupture, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the biomechanical mechanisms of dynamic knee valgus and the impact of subtalar pronation, particularly due to decreased medial longitudinal arch, on knee injury risk, highlighting the importance of prevention and intervention strategies for athlete health. Read more about this study
- Who is it for?
- Ages 16 to 25 years, women only
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Antipronation Taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2021to 1 Feb 2022
- Phase
- Interventional
- 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 16 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Actively playing volleyball for at least 5 years, A drop of 10 mm or more in the navicular drop test, A score of ≥ +4 according to the A foot posture index.
Who cannot join
- A history of lower extremity injury within the last 3 months, A history of ankle and/or knee surgery, Having non-structural instability, A history of congenital or traumatic deformity in the lower extremity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Subtalar Joint Antipronation Taping on the Dynamic Knee Valgus in Female Volleyball Players with Low Medial Arch: a Double Blinded Randomized Controlled Trial
This study aims to investigate the biomechanical mechanisms of dynamic knee valgus and the impact of subtalar pronation, particularly due to decreased medial longitudinal arch, on knee injury risk, highlighting the importance of prevention and intervention strategies for athlete health.
Read the detailed description
Dynamic knee valgus is an abnormal movement pattern of the lower extremity, formed by the combination of femoral adduction and internal rotation, tibial abduction and internal rotation, and subtalar pronation, and it is a significant risk factor for knee injuries. The foot and ankle represent the first link in the lower extremity kinetic chain, and a mechanical relationship between subtalar joint motion and tibial rotation triggers internal rotation of the tibia during weight-bearing. This is particularly more pronounced in female athletes, as increased foot pronation and medial longitudinal arch (MLA) drop contribute to dynamic knee valgus. Supporting the MLA has become increasingly important in injury prevention, as there is evidence in the literature showing that interventions to reduce foot pronation decrease dynamic knee valgus and help prevent patellofemoral pain and anterior cruciate ligament injuries.
The aim of this study is to investigate the effects of antipronation taping on dynamic knee valgus and knee flexion angle during functional jump tests in female volleyball players with MLA drop. Innovative taping materials, such as Dynamic Tape, when applied correctly, can support the MLA, reduce tibial rotation, and decrease abnormal movements. While there is existing evidence that MLA-supporting orthotics reduce such injury risks, no studies have specifically examined antipronation taping with Dynamic Tape applied to the subtalar joint. This study seeks to explore modifiable risk factors associated with common knee injuries in female athletes from a foot posture perspective and contribute to athlete health.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Antipronation Taping, Sham
- Keywords
- Pes planus, ACL, Dynamic Tape
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antipronation TapingOther
Before applying the tape, its length was measured by passing it over the areas on the foot where it would be applied. The tape was first attached to the medial side of the big toe, with tension in the direction of flexion and abduction of the toe. The ankle was then positioned in full plantar flexion. The tape was applied from the medial side of the foot towards the heel, wrapping around it, and then directed towards the sole. While the foot was in an inversion position at the navicular level, the tape was applied with maximum tension from medial to lateral and brought back to the sole. The remainder of the tape, with maximum tension, was applied from the sole to the dorsal side of the ankle, ending without tension at the proximal and lateral side of the leg. A second strip of tape, with maximum tension, was applied to support the medial longitudinal arch. The ends of the tape were placed over the malleoli without tension, aiming to reduce excessive pronation.
ShamOther
In the sham taping application, the length of the tape was measured by passing it over the areas where it would be applied. The tape was applied to the medial side of the big toe, but without tension, simply placed. Then, the tape was directed towards the sole of the foot, passing over the heel. At the navicular level, the tape was applied from medial to lateral, returning to the sole without tension. A second strip of tape was applied to the sole without tension. The ends of the tape were placed over the malleoli without stretching. Since no tension was applied, this application was only placed and has a limited effect on reducing excessive pronation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dynamic Tape Receives: Other: Antipronation Taping |
| Control | Sham comparator | Sham Group Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Leg Squat Test
In this test, athletes were instructed to perform a single-leg squat with their hands on their waist, maintaining balance for as long as possible, preferably for 5 seconds. Only trials that reached the required minimum flexion angle and maintained balance were considered valid. Three valid attempts were performed. During the tests, video recordings were made from both the front and the side. The footage was analyzed using the Microsoft OptoJump® Next program with a 2D analysis method to measure knee flexion and valgus angles.
Measured: Pre-taping and within 1 hour after taping
Single Leg Landing Test
For this test, each athlete was asked to step off a 30 cm high box and extend the measurement leg forward to drop downward. The maximum knee valgus and flexion angles at the end of the drop were measured using two camera recordings, one from the front and one from the side.
During the tests, video recordings were made from both the front and the side. The footage was analyzed using the Microsoft OptoJump® Next program with a 2D analysis method to measure knee flexion and valgus angles.
Measured: Pre-taping and within 1 hour after taping
Vertical Drop Jump Test
In this test, athletes were instructed to stand with their feet shoulder-width apart on a 30 cm high box. They were then asked to jump into the square area in front of the box and immediately jump as far as possible using their arms for assistance. The test was completed once the athlete had made three successful jumps. The average of the three jumps was recorded.
During the tests, video recordings were made from both the front and the side. The footage was analyzed using the Microsoft OptoJump® Next program with a 2D analysis method to measure knee flexion and valgus angles.
Measured: Pre-taping and within 1 hour after taping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start10 Aug 2021
- Primary completion1 Nov 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Akıncı, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752109
- Sponsor's protocol ID
- DTape01
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subtalar Joint Antipronation Taping on the Dynamic Knee Valgus in Female Volleyball Players with Low Medial Arch: a Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06752109
- Acronym / sponsor ID
- DTape01
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Pes planus, ACL, Dynamic Tape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 30 Dec 2024 (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.
This study aims to investigate the biomechanical mechanisms of dynamic knee valgus and the impact of subtalar pronation, particularly due to decreased medial longitudinal arch, on knee injury risk, highlighting the importance of prevention and intervention strategies for athlete health.
Detailed description
Dynamic knee valgus is an abnormal movement pattern of the lower extremity, formed by the combination of femoral adduction and internal rotation, tibial abduction and internal rotation, and subtalar pronation, and it is a significant risk factor for knee injuries. The foot and ankle represent the first link in the lower extremity kinetic chain, and a mechanical relationship between subtalar joint motion and tibial rotation triggers internal rotation of the tibia during weight-bearing. This is particularly more pronounced in female athletes, as increased foot pronation and medial longitudinal arch (MLA) drop contribute to dynamic knee valgus. Supporting the MLA has become increasingly important in injury prevention, as there is evidence in the literature showing that interventions to reduce foot pronation decrease dynamic knee valgus and help prevent patellofemoral pain and anterior cruciate ligament injuries.
The aim of this study is to investigate the effects of antipronation taping on dynamic knee valgus and knee flexion angle during functional jump tests in female volleyball players with MLA drop. Innovative taping materials, such as Dynamic Tape, when applied correctly, can support the MLA, reduce tibial rotation, and decrease abnormal movements. While there is existing evidence that MLA-supporting orthotics reduce such injury risks, no studies have specifically examined antipronation taping with Dynamic Tape applied to the subtalar joint. This study seeks to explore modifiable risk factors associated with common knee injuries in female athletes from a foot posture perspective and contribute to athlete health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Antipronation TapingDynamic Tape |
| Control | Sham comparator | Other: ShamSham Group |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Actively playing volleyball for at least 5 years, A drop of 10 mm or more in the navicular drop test, A score of ≥ +4 according to the A foot posture index.
Key exclusion criteria (1 listed)
- A history of lower extremity injury within the last 3 months, A history of ankle and/or knee surgery, Having non-structural instability, A history of congenital or traumatic deformity in the lower extremity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antipronation TapingBefore applying the tape, its length was measured by passing it over the areas on the foot where it would be applied. The tape was first attached to the medial side of the big toe, with tension in the direction of flexion and abduction of the toe. The ankle was then positioned in full plantar flexion. The tape was applied from the medial side of the foot towards the heel, wrapping around it, and then directed towards the sole. While the foot was in an inversion position at the navicular level, the tape was applied with maximum tension from medial to lateral and brought back to the sole. The remainder of the tape, with maximum tension, was applied from the sole to the dorsal side of the ankle, ending without tension at the proximal and lateral side of the leg. A second strip of tape, with maximum tension, was applied to support the medial longitudinal arch. The ends of the tape were placed over the malleoli without tension, aiming to reduce excessive pronation. | Other | Intervention |
| ShamIn the sham taping application, the length of the tape was measured by passing it over the areas where it would be applied. The tape was applied to the medial side of the big toe, but without tension, simply placed. Then, the tape was directed towards the sole of the foot, passing over the heel. At the navicular level, the tape was applied from medial to lateral, returning to the sole without tension. A second strip of tape was applied to the sole without tension. The ends of the tape were placed over the malleoli without stretching. Since no tension was applied, this application was only placed and has a limited effect on reducing excessive pronation. | Other | Control |
Primary outcome
Single Leg Squat Test
Time frame: Pre-taping and within 1 hour after taping
In this test, athletes were instructed to perform a single-leg squat with their hands on their waist, maintaining balance for as long as possible, preferably for 5 seconds. Only trials that reached the required minimum flexion angle and maintained balance were considered valid. Three valid attempts were performed. During the tests, video recordings were made from both the front and the side. The footage was analyzed using the Microsoft OptoJump® Next program with a 2D analysis method to measure knee flexion and valgus angles.
Single Leg Landing Test
Time frame: Pre-taping and within 1 hour after taping
For this test, each athlete was asked to step off a 30 cm high box and extend the measurement leg forward to drop downward. The maximum knee valgus and flexion angles at the end of the drop were measured using two camera recordings, one from the front and one from the side. During the tests, video recordings were made from both the front and the side. The footage was analyzed using the Microsoft OptoJump® Next program with a 2D analysis method to measure knee flexion and valgus angles.
Vertical Drop Jump Test
Time frame: Pre-taping and within 1 hour after taping
In this test, athletes were instructed to stand with their feet shoulder-width apart on a 30 cm high box. They were then asked to jump into the square area in front of the box and immediately jump as far as possible using their arms for assistance. The test was completed once the athlete had made three successful jumps. The average of the three jumps was recorded. During the tests, video recordings were made from both the front and the side. The footage was analyzed using the Microsoft OptoJump® Next program with a 2D analysis method to measure knee flexion and valgus angles.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antipronation Taping in people with Anterior Cruciate Ligament Rupture, run by Ankara Yildirim Beyazıt 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Leg Squat Test (time frame: Pre-taping and within 1 hour after taping). The study lists 3 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 30 Jan 2025.