Knee ValgusNCT04769063
An Analysis of Kinesio® Tape on Mitigation of Dynamic Knee Valgus
A study testing Kinesio Tape in people with Knee Valgus, run by North Dakota State University at 1 site in United States.
Trial summary
Participants will completed a 5 minute warm-up on a stationary bike. Next, participants will perform 3 practice trials of the double leg jump landing (DJL) test off of a 30 cm box. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Knee Valgus
- What is being tested?
- Kinesio Tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 5 Apr 2021
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- current participation in basketball or volleyball
Who cannot join
- present pain with jumping or landing
- history of lower limb surgery within the12 months of the study
- any contraindications to Kinesio® Tape
Trial locations and contacts
1 site in 1 country.
United States1 site
North Dakota State University
Fargo, North Dakota, 58108
About this study
Participants will completed a 5 minute warm-up on a stationary bike. Next, participants will perform 3 practice trials of the double leg jump landing (DJL) test off of a 30 cm box. In order for the trial to count the participants need to maintain their landing posture for at least 2 seconds, if they are unable to do so the trial will be repeated.
After the completion of three practice trials of the DJL test, the first taping condition will be applied. Each participant will receive 3 taping conditions to the dominant leg, a gluteus medius facilitation (GM), a spiral technique (ST), and no tape (NT). The order of conditions will be randomized.
Read more
The use of a no tape condition will act a control for both the jumping protocol and the Y-balance test. For this condition, no tape or intervention of any kind will be applied to the subject before completing either tasks. Regardless of the order of randomly assigned taping condition, the participant will rest 10 minutes in a non-weight bearing position before completing a round of testing.
During the 10-minute rest, 3D motion analysis sensors will be placed on the participant to assess hip internal rotation and knee valgus in the frontal plane. After the sensors are applied, the first follow-up Y Balance Test will be completed.
Each participant will complete the Y Balance Test 3 times, once for each condition. For the trial to count, the reach foot is not permitted to touch the floor and the hands have to remain stationary on the pelvis. If the participant fails to meet the testing criteria, the trial will be repeated. At the end of the trial, each testing direction distance will be written down and a mean score will be calculated.
Following the first Y balance test, three DJL tests will be performed, each separated by a 60-second rest period. Once the participant completes 3 approved trials, the first taping condition will be removed and the procedure will be repeated for the second and third taping procedures.
Read the detailed description
The facilitative gluteus medius application was applied from origin to insertion of the muscle, as specified by Dr. Kase (2013). The subject was positioned in side-lying with the dominant leg facing up. The CKTP cut a Y-strip of Kinesio® Tex Classic Tape the same distance from the participant's ASIS to the greater trochanter of the femur. The tape was anchored at the ASIS with no tension followed by the participant moving into approximately 90° hip flexion, adduction, and internal rotation. Then, each tail of the Y-strip was applied at 25% tension towards the greater trochanter where it was anchored again with no tension. Following application, the participant was instructed to remain in a position of comfort for 10 minutes before continuing with the study protocol.
The second taping condition utilized is a spiral technique (ST), applied with Kinesio® Tex Performance Plus Tape. Participant positioning included standing in an open-packed, double-leg stance with feet approximately hip width apart. The CKTP anchored an I-strip of tape with no tension on the participant's medial aspect of the middle, tibia. With a stabilizing hand on the anchor, the practitioner pulled the tape with 75-100% tension and applied towards the lateral aspect of the tibiofemoral joint, Once the tape moved to the posterior side of the knee, the CKTP reduced the tension to 0% over the popliteal fossa so as to reduce skin tearing and provide another mechanism for pulling the knee out of valgum. When the tape crossed diagonally over the popliteal fossa, the CKTP again employed at 75-100% tension from the medial femoral condyle to the vastus lateralis. The tape was then secured to the posterior thigh with an anchor at 0% tension. Thus, the tape created a spiral shape up the participants' leg. Again, the subject was directed to rest comfortably in a non-weight bearing position for 10 minutes.
- Conditions
- Knee Valgus
- Being tested
- Kinesio Tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapeOther
Gluteus medius facilitation and knee spiral taping techniques will be applied to treat dynamic knee valgus
| Study group | Role | What they receive |
|---|---|---|
| Hip | Experimental | Not described Receives: Other: Kinesio Tape |
| Knee | Experimental | Not described Receives: Other: Kinesio Tape |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three dimensional motion analysis
Assessment of knee valgus in the frontal plane
Measured: 1 day
Y-balance test
Functional screening tool, which can be used to assess lower extremity stability, monitor rehabilitation progress, to understand deficits after injury, and identify athletes at high risk for lower extremity injury
Measured: 1 day
Drop jump landing test
Clinical test with a high reliability of 95% to screen for lower limb injury, including a high specificity (46.07%) and sensitivity (95.04%) to predict ACL injury
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start26 Feb 2021
- Primary completion5 Apr 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ValgusStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769063
- Sponsor's protocol ID
- IRB0003317
- Status last verified
- Jun 2021
- First submitted
- 8 Feb 2021
- Last updated
- 7 Jun 2021
- 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 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Kinesio® Tape on Mitigation of Dynamic Knee Valgus
- ClinicalTrials.gov ID
- NCT04769063
- Acronym / sponsor ID
- IRB0003317
- Conditions
- Knee Valgus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 24 Feb 2021 (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.
Participants will completed a 5 minute warm-up on a stationary bike. Next, participants will perform 3 practice trials of the double leg jump landing (DJL) test off of a 30 cm box. In order for the trial to count the participants need to maintain their landing posture for at least 2 seconds, if they are unable to do so the trial will be repeated.
After the completion of three practice trials of the DJL test, the first taping condition will be applied. Each participant will receive 3 taping conditions to the dominant leg, a gluteus medius facilitation (GM), a spiral technique (ST), and no tape (NT). The order of conditions will be randomized.
The use of a no tape condition will act a control for both the jumping protocol and the Y-balance test. For this condition, no tape or intervention of any kind will be applied to the subject before completing either tasks. Regardless of the order of randomly assigned taping condition, the participant will rest 10 minutes in a non-weight bearing position before completing a round of testing.
During the 10-minute rest, 3D motion analysis sensors will be placed on the participant to assess hip internal rotation and knee valgus in the frontal plane. After the sensors are applied, the first follow-up Y Balance Test will be completed.
Each participant will complete the Y Balance Test 3 times, once for each condition. For the trial to count, the reach foot is not permitted to touch the floor and the hands have to remain stationary on the pelvis. If the participant fails to meet the testing criteria, the trial will be repeated. At the end of the trial, each testing direction distance will be written down and a mean score will be calculated.
Following the first Y balance test, three DJL tests will be performed, each separated by a 60-second rest period. Once the participant completes 3 approved trials, the first taping condition will be removed and the procedure will be repeated for the second and third taping procedures.
Detailed description
The facilitative gluteus medius application was applied from origin to insertion of the muscle, as specified by Dr. Kase (2013). The subject was positioned in side-lying with the dominant leg facing up. The CKTP cut a Y-strip of Kinesio® Tex Classic Tape the same distance from the participant's ASIS to the greater trochanter of the femur. The tape was anchored at the ASIS with no tension followed by the participant moving into approximately 90° hip flexion, adduction, and internal rotation. Then, each tail of the Y-strip was applied at 25% tension towards the greater trochanter where it was anchored again with no tension. Following application, the participant was instructed to remain in a position of comfort for 10 minutes before continuing with the study protocol.
The second taping condition utilized is a spiral technique (ST), applied with Kinesio® Tex Performance Plus Tape. Participant positioning included standing in an open-packed, double-leg stance with feet approximately hip width apart. The CKTP anchored an I-strip of tape with no tension on the participant's medial aspect of the middle, tibia. With a stabilizing hand on the anchor, the practitioner pulled the tape with 75-100% tension and applied towards the lateral aspect of the tibiofemoral joint, Once the tape moved to the posterior side of the knee, the CKTP reduced the tension to 0% over the popliteal fossa so as to reduce skin tearing and provide another mechanism for pulling the knee out of valgum. When the tape crossed diagonally over the popliteal fossa, the CKTP again employed at 75-100% tension from the medial femoral condyle to the vastus lateralis. The tape was then secured to the posterior thigh with an anchor at 0% tension. Thus, the tape created a spiral shape up the participants' leg. Again, the subject was directed to rest comfortably in a non-weight bearing position for 10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hip | Experimental | Other: Kinesio Tape |
| Knee | Experimental | Other: Kinesio Tape |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- current participation in basketball or volleyball
Key exclusion criteria (3 listed)
- present pain with jumping or landing
- history of lower limb surgery within the12 months of the study
- any contraindications to Kinesio® Tape
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 |
|---|---|---|
| Kinesio TapeGluteus medius facilitation and knee spiral taping techniques will be applied to treat dynamic knee valgus | Other | Hip, Knee |
Primary outcome
Three dimensional motion analysis
Time frame: 1 day
Assessment of knee valgus in the frontal plane
Y-balance test
Time frame: 1 day
Functional screening tool, which can be used to assess lower extremity stability, monitor rehabilitation progress, to understand deficits after injury, and identify athletes at high risk for lower extremity injury
Drop jump landing test
Time frame: 1 day
Clinical test with a high reliability of 95% to screen for lower limb injury, including a high specificity (46.07%) and sensitivity (95.04%) to predict ACL injury
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 7 Jun 2021.
- 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.
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 Kinesio Tape in people with Knee Valgus, run by North Dakota State University at 1 site in United States.
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 3 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 7 Jun 2021. 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 United States. 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?
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?
Three dimensional motion analysis (time frame: 1 day). 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 7 Jun 2021.