Anterior Cruciate Ligament InjuryNCT02271061
Effects of Elastic Therapeutic Tape on Biomechanical Changes of Knee Joint During Drop Vertical Jump in ACL Injuries
A study testing Kinesio tape in people with Anterior Cruciate Ligament Injury, run by Mahidol University.
Trial summary
The purpose of this study to investigate joint angle and joint moment in flexion-extension, adduction-abduction and internal -external rotation of elastic therapeutic tape and elastic therapeutic tape are effective in ACL-injuries subjects during drop vertical jump.This study requires ACL-injuries participants age… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Kinesio tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2015
- 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 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- ACL-injuries with grade I-II at least 8 weeks by measuring joint laxity test by stress X-ray with Telos (side to side difference between 3 - 8 mm.)
- No collateral ligaments and meniscus injuries
- No joint pain and knee joint effusion (less than 2 cm. from the opposite side measuring at joint line
- No history of previous injuries in other structure of lower extremities that resulted in ligamentous laxity at ankle and hip
- No current medical problems such as vestibular system, visual system or neurological condition that can impair their ability to perform a sidestep cutting task
- No joint and structural deformity such as flat feet, genu valgus and genu varus
- Able to complete functional test (Single hop for distance and Triple hop for distance) which the distance is not less than 85% of unaffected side
Who cannot join
- Knee joint swelling is greater than 2 cm. of unaffected side
- Joint laxity test by stress X-ray with Telos (side to side difference greater than 8 mm.)
- Unable to complete functional test (Single hop for distance and Triple hop for distance) which the distance is less than 85% of unaffected side
About this study
The purpose of this study to investigate joint angle and joint moment in flexion-extension, adduction-abduction and internal -external rotation of elastic therapeutic tape and elastic therapeutic tape are effective in ACL-injuries subjects during drop vertical jump.This study requires ACL-injuries participants age range between 18 and 45 years old. The 3D motion analysis system (BTS, ITALY) and force plate (Kistler, USA) will be used for measure joint angle and joint moment during drop vertical jump movement.
Read the detailed description
#Participants ACL-injures subjects ACL-injury group will be recruit people with ACL-injuries with grade I-II at least 8 weeks by measuring joint laxity test by stress X-ray with Telos (side to side difference between 3 - 8 mm.) .
Inclusion criteria of ACL-injuries group are: 1) no collateral ligaments and meniscus injuries , 2) no joint pain and knee joint effusion (less than 2 cm. from the opposite side measuring at joint line, 3) no history of previous injuries in other structure of lower extremities that resulted in ligamentous laxity at ankle and hip, 4) no current medical problems such as vestibular system, visual system or neurological condition that can impair their ability to perform a sidestep cutting task, 5) no joint and structural deformity such as flat feet, genu valgus and genu varus, 6) able to complete functional test (Single hop for distance and Triple hop for distance) which the distance is not less than 85% of unaffected side .
Exclusion criteria included 1) knee joint swelling is greater than 2 cm. of unaffected side, 2) joint laxity test by stress X-ray with Telos (side to side difference greater than 8 mm.)
- Instrumentation
- Three-dimensional motion analysis system (Bioengineering Inc., ITALY)
- Visual 3D software (C-motion, USA)
- A force platform with 60x40x10 centimeters in size (Kistler Instrument Corp., USA)
- Running shoes (Adidas) US Size 7 , 8 , 9, 10
- Goniometer
- Vernier caliber
- Measuring tape
- Therapeutic tape ; (KinesioTex®)
- Telos arthrometer GA III/E (Metax GmbH)
- International Knee Documentation Committee Score (IKDC)
- Knee Osteoarthritis Outcome Score (KOOS)
- Subject preparation for participants with ACL-injuries Participants will be asked to fill in a questionnaire about age, height, weight and history of injury or musculoskeletal problems. Participants will be informed to make understanding of purposes, methods and advantages of the study. Also, all participants will be asked to sign a consent form. IKDC and KOOD interviews will be conducted.The test including hop test and drop vertical jump will be conducted at Faculty of Medicine Ramathibodi, Mahidol University.
Anthropometric data, navicular drop test, ROM and muscle strength at knee joint will be performed in each participant. Participants will be asked to perform single hop for distance and triple hop on both side of their legs.
Stress X-ray by Telos® Participants will be screened joint laxity by stress x-ray with Telos. Lateral view x-ray will be performed in side lying position with knee flexion between 10 to 20 degrees. Front cushion pad will be applied on distal femur and distal tibia. Pressure load will be applied on 6 cm below knee joint line at 15 daN.
Participants with ACL injuries subjects will rest for 10 minute in the quiet room and elastic therapeutic tape will be applied on affected side. Drop vertical jump will be performed follow by running 30 minutes at speed 7 km/hr. Participants will be asked to perform drop vertical jump task again after running.
Drop vertical jump Drop vertical jump landing trails was performed on 31 cm. box . Participants were informed to jump with two hands over head as high as possible and landing on force plate with each foot on separate force plate . Participants were asked to perform the task until reach three successful trials. Successful trial was defined as participants can land on force plate with each foot on separate force plate without further steps.
#Parameters
Knee joint angle and moment at initial contact and weight acceptance phase
- Flexion - Extension
- Adduction - Abduction
- Internal - External rotation
- Statistics All data will be presented in mean ± stand error of mean. All the statistical test will be performed by using the SPSS for window version 17 program. The level of significance for difference between groups will be set at p< 0.05.
Comparison of 3D joint angles and moments between affected leg and unaffected leg in ACL-injuries group during side step movement will be tested by Paired T test.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Kinesio tape, Control tape
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapeDevice
Elastic therapeutic tape is one type of elastic tape that is widely used for various treatment including rehabilitation and sports injuries . The elastic therapeutic tape has different characteristics from other kind of tape. It has ability to stretch around 130 - 140% from original length and recoil back to starting length after applying the tape. Tape produces pulling force on skin which lifts and folds layers of epidermis . Pulling force provides an appropriate alignment which can facilitate and inhibit muscle contraction.It has been claimed for several benefits such as supportingly injured muscles, increased proprioception, stimulated and inhibited muscle activity, relieved pain, increased range of motion, and improved blood and lymph flow.
Control tapeDevice
Apply tape in same technique without tension.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Tape | Experimental | Taping method will be performed in supine position .The taping technique will be started at tibial tuberosity to medial and lateral epicondyles of the femur. The tape will be cut in I shape with 30 cm. The back paper of tape will be removed from the center of tape and both end of the back paper will be placed at each end of tape. Center of the tape will be placed on the tibial tuberosity with no tension. Participants' knee will be bend approximately 20 - 30 degrees. The tape will be pulled at 1/3 of each end with 75% of available tension along the medial and lateral collateral ligaments and the tibia will be pushed to the back. The end of the tape will be placed with no tension toward the medial and lateral aspects of the thigh . Receives: Device: Kinesio tape |
| Control tape | Sham comparator | Apply tape in same technique without tension. Receives: Device: Control tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee joint motion
Knee joint angle and moment at initial contact and weight acceptance phase
- Flexion - Extension
- Adduction - Abduction
- Internal - External rotation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Thammasat University, Liverpool John Moores University
- Responsible party
- Sponsor
- Investigators
- Wat Limruengrangrat, PhD, Principal investigator, Collage of Sports Sciences and Technology, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271061
- Sponsor's protocol ID
- MURA2014/415
- Status last verified
- Jan 2016
- First submitted
- 18 Oct 2014
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beldame J, Bertiaux S, Roussignol X, Lefebvre B, Adam JM, Mouilhade F, Dujardin F. Laxity measurements using stress radiography to assess anterior cruciate ligament tears. Orthop Traumatol Surg Res. 2011 Feb;97(1):34-43. doi: 10.1016/j.otsr.2010.08.004. Epub 2010 Dec 18.
PubMed 21169080Beldame J, Mouchel S, Bertiaux S, Adam JM, Mouilhade F, Roussignol X, Dujardin F. Anterior knee laxity measurement: comparison of passive stress radiographs Telos((R)) and "Lerat", and GNRB((R)) arthrometer. Orthop Traumatol Surg Res. 2012 Nov;98(7):744-50. doi: 10.1016/j.otsr.2012.05.017. Epub 2012 Oct 16.
PubMed 23084264Bjornaraa J, Di Fabio RP. Knee kinematics following acl reconstruction in females; the effect of vision on performance during a cutting task. Int J Sports Phys Ther. 2011 Dec;6(4):271-84.
PubMed 22163089Ford KR, Myer GD, Hewett TE. Valgus knee motion during landing in high school female and male basketball players. Med Sci Sports Exerc. 2003 Oct;35(10):1745-50. doi: 10.1249/01.MSS.0000089346.85744.D9.
PubMed 14523314Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. doi: 10.1177/0363546504269591. Epub 2005 Feb 8.
PubMed 15722287McLean SG, Huang X, van den Bogert AJ. Association between lower extremity posture at contact and peak knee valgus moment during sidestepping: implications for ACL injury. Clin Biomech (Bristol). 2005 Oct;20(8):863-70. doi: 10.1016/j.clinbiomech.2005.05.007.
PubMed 16005555Swirtun LR, Jansson A, Renstrom P. The effects of a functional knee brace during early treatment of patients with a nonoperated acute anterior cruciate ligament tear: a prospective randomized study. Clin J Sport Med. 2005 Sep;15(5):299-304. doi: 10.1097/01.jsm.0000180018.14394.7e.
PubMed 16162987
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Elastic Therapeutic Tape on Biomechanical Changes of Knee Joint During Drop Vertical Jump in ACL Injuries
- ClinicalTrials.gov ID
- NCT02271061
- Acronym / sponsor ID
- MURA2014/415
- Conditions
- Anterior Cruciate Ligament Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Thammasat University, Liverpool John Moores University
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Oct 2014 (estimated)
- 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.
The purpose of this study to investigate joint angle and joint moment in flexion-extension, adduction-abduction and internal -external rotation of elastic therapeutic tape and elastic therapeutic tape are effective in ACL-injuries subjects during drop vertical jump.This study requires ACL-injuries participants age range between 18 and 45 years old. The 3D motion analysis system (BTS, ITALY) and force plate (Kistler, USA) will be used for measure joint angle and joint moment during drop vertical jump movement.
Detailed description
#Participants ACL-injures subjects ACL-injury group will be recruit people with ACL-injuries with grade I-II at least 8 weeks by measuring joint laxity test by stress X-ray with Telos (side to side difference between 3 - 8 mm.) .
Inclusion criteria of ACL-injuries group are: 1) no collateral ligaments and meniscus injuries , 2) no joint pain and knee joint effusion (less than 2 cm. from the opposite side measuring at joint line, 3) no history of previous injuries in other structure of lower extremities that resulted in ligamentous laxity at ankle and hip, 4) no current medical problems such as vestibular system, visual system or neurological condition that can impair their ability to perform a sidestep cutting task, 5) no joint and structural deformity such as flat feet, genu valgus and genu varus, 6) able to complete functional test (Single hop for distance and Triple hop for distance) which the distance is not less than 85% of unaffected side .
Exclusion criteria included 1) knee joint swelling is greater than 2 cm. of unaffected side, 2) joint laxity test by stress X-ray with Telos (side to side difference greater than 8 mm.)
- Instrumentation
- Three-dimensional motion analysis system (Bioengineering Inc., ITALY)
- Visual 3D software (C-motion, USA)
- A force platform with 60x40x10 centimeters in size (Kistler Instrument Corp., USA)
- Running shoes (Adidas) US Size 7 , 8 , 9, 10
- Goniometer
- Vernier caliber
- Measuring tape
- Therapeutic tape ; (KinesioTex®)
- Telos arthrometer GA III/E (Metax GmbH)
- International Knee Documentation Committee Score (IKDC)
- Knee Osteoarthritis Outcome Score (KOOS)
- Subject preparation for participants with ACL-injuries Participants will be asked to fill in a questionnaire about age, height, weight and history of injury or musculoskeletal problems. Participants will be informed to make understanding of purposes, methods and advantages of the study. Also, all participants will be asked to sign a consent form. IKDC and KOOD interviews will be conducted.The test including hop test and drop vertical jump will be conducted at Faculty of Medicine Ramathibodi, Mahidol University.
Anthropometric data, navicular drop test, ROM and muscle strength at knee joint will be performed in each participant. Participants will be asked to perform single hop for distance and triple hop on both side of their legs.
Stress X-ray by Telos® Participants will be screened joint laxity by stress x-ray with Telos. Lateral view x-ray will be performed in side lying position with knee flexion between 10 to 20 degrees. Front cushion pad will be applied on distal femur and distal tibia. Pressure load will be applied on 6 cm below knee joint line at 15 daN.
Participants with ACL injuries subjects will rest for 10 minute in the quiet room and elastic therapeutic tape will be applied on affected side. Drop vertical jump will be performed follow by running 30 minutes at speed 7 km/hr. Participants will be asked to perform drop vertical jump task again after running.
Drop vertical jump Drop vertical jump landing trails was performed on 31 cm. box . Participants were informed to jump with two hands over head as high as possible and landing on force plate with each foot on separate force plate . Participants were asked to perform the task until reach three successful trials. Successful trial was defined as participants can land on force plate with each foot on separate force plate without further steps.
#Parameters
Knee joint angle and moment at initial contact and weight acceptance phase
- Flexion - Extension
- Adduction - Abduction
- Internal - External rotation
- Statistics All data will be presented in mean ± stand error of mean. All the statistical test will be performed by using the SPSS for window version 17 program. The level of significance for difference between groups will be set at p< 0.05.
Comparison of 3D joint angles and moments between affected leg and unaffected leg in ACL-injuries group during side step movement will be tested by Paired T test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio Tape | Experimental | Device: Kinesio tapeTaping method will be performed in supine position .The taping technique will be started at tibial tuberosity to medial and lateral epicondyles of the femur. The tape will be cut in I shape with 30 cm. The back paper of tape will be removed from the center of tape and both end of the back paper will be placed at each end of tape. Center of the tape will be placed on the tibial tuberosity with no tension. Participants' knee will be bend approximately 20 - 30 degrees. The tape will be pulled at 1/3 of each end with 75% of available tension along the medial and lateral collateral ligaments and the tibia will be pushed to the back. The end of the tape will be placed with no tension toward the medial and lateral aspects of the thigh . |
| Control tape | Sham comparator | Device: Control tapeApply tape in same technique without tension. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- ACL-injuries with grade I-II at least 8 weeks by measuring joint laxity test by stress X-ray with Telos (side to side difference between 3 - 8 mm.)
- No collateral ligaments and meniscus injuries
- No joint pain and knee joint effusion (less than 2 cm. from the opposite side measuring at joint line
- No history of previous injuries in other structure of lower extremities that resulted in ligamentous laxity at ankle and hip
- No current medical problems such as vestibular system, visual system or neurological condition that can impair their ability to perform a sidestep cutting task
Key exclusion criteria (3 listed)
- Knee joint swelling is greater than 2 cm. of unaffected side
- Joint laxity test by stress X-ray with Telos (side to side difference greater than 8 mm.)
- Unable to complete functional test (Single hop for distance and Triple hop for distance) which the distance is less than 85% of unaffected side
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 tapeElastic therapeutic tape is one type of elastic tape that is widely used for various treatment including rehabilitation and sports injuries . The elastic therapeutic tape has different characteristics from other kind of tape. It has ability to stretch around 130 - 140% from original length and recoil back to starting length after applying the tape. Tape produces pulling force on skin which lifts and folds layers of epidermis . Pulling force provides an appropriate alignment which can facilitate and inhibit muscle contraction.It has been claimed for several benefits such as supportingly injured muscles, increased proprioception, stimulated and inhibited muscle activity, relieved pain, increased range of motion, and improved blood and lymph flow. | Device | Kinesio Tape |
| Control tapeApply tape in same technique without tension. | Device | Control tape |
Primary outcome
Knee joint motion
Time frame: 6 months
Knee joint angle and moment at initial contact and weight acceptance phase 1. Flexion - Extension 2. Adduction - Abduction 3. Internal - External rotation
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 11 Jan 2016.
- Background: PubMed 21169080Beldame J, Bertiaux S, Roussignol X, Lefebvre B, Adam JM, Mouilhade F, Dujardin F. Laxity measurements using stress radiography to assess anterior cruciate ligament tears. Orthop Traumatol Surg Res. 2011 Feb;97(1):34-43. doi: 10.1016/j.otsr.2010.08.004. Epub 2010 Dec 18.
- Background: PubMed 23084264Beldame J, Mouchel S, Bertiaux S, Adam JM, Mouilhade F, Roussignol X, Dujardin F. Anterior knee laxity measurement: comparison of passive stress radiographs Telos((R)) and "Lerat", and GNRB((R)) arthrometer. Orthop Traumatol Surg Res. 2012 Nov;98(7):744-50. doi: 10.1016/j.otsr.2012.05.017. Epub 2012 Oct 16.
- Background: PubMed 22163089Bjornaraa J, Di Fabio RP. Knee kinematics following acl reconstruction in females; the effect of vision on performance during a cutting task. Int J Sports Phys Ther. 2011 Dec;6(4):271-84.
- Background: PubMed 14523314Ford KR, Myer GD, Hewett TE. Valgus knee motion during landing in high school female and male basketball players. Med Sci Sports Exerc. 2003 Oct;35(10):1745-50. doi: 10.1249/01.MSS.0000089346.85744.D9.
- Background: PubMed 15722287Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. doi: 10.1177/0363546504269591. Epub 2005 Feb 8.
- Background: PubMed 16005555McLean SG, Huang X, van den Bogert AJ. Association between lower extremity posture at contact and peak knee valgus moment during sidestepping: implications for ACL injury. Clin Biomech (Bristol). 2005 Oct;20(8):863-70. doi: 10.1016/j.clinbiomech.2005.05.007.
- Background: PubMed 16162987Swirtun LR, Jansson A, Renstrom P. The effects of a functional knee brace during early treatment of patients with a nonoperated acute anterior cruciate ligament tear: a prospective randomized study. Clin J Sport Med. 2005 Sep;15(5):299-304. doi: 10.1097/01.jsm.0000180018.14394.7e.
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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.
Wat Limruengrangrat, PhD principal investigator
Collage of Sports Sciences and Technology, Mahidol University
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio tape in people with Anterior Cruciate Ligament Injury, run by Mahidol University.
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 7 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 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Knee joint motion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02271061, which also lists 7 linked publications.
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 11 Jan 2016.