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Effects of Elastic Therapeutic Tape on Biomechanical Changes of Knee Joint During Drop Vertical Jump in ACL Injuries

Primary Purpose

Anterior Cruciate Ligament Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kinesio tape
Control tape
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anterior Cruciate Ligament Injury

Eligibility Criteria

18 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.)
  2. No collateral ligaments and meniscus injuries
  3. No joint pain and knee joint effusion (less than 2 cm. from the opposite side measuring at joint line
  4. No history of previous injuries in other structure of lower extremities that resulted in ligamentous laxity at ankle and hip
  5. No current medical problems such as vestibular system, visual system or neurological condition that can impair their ability to perform a sidestep cutting task
  6. No joint and structural deformity such as flat feet, genu valgus and genu varus
  7. 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:

  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.)
  3. Unable to complete functional test (Single hop for distance and Triple hop for distance) which the distance is less than 85% of unaffected side

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Kinesio Tape

    Control tape

    Arm Description

    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 .

    Apply tape in same technique without tension.

    Outcomes

    Primary Outcome Measures

    Knee joint motion
    Knee joint angle and moment at initial contact and weight acceptance phase Flexion - Extension Adduction - Abduction Internal - External rotation

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 2014
    Last Updated
    January 7, 2016
    Sponsor
    Mahidol University
    Collaborators
    Thammasat University, Liverpool John Moores University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02271061
    Brief Title
    Effects of Elastic Therapeutic Tape on Biomechanical Changes of Knee Joint During Drop Vertical Jump in ACL Injuries
    Official Title
    Effects of Elastic Therapeutic Tape on Biomechanical Changes of Knee Joint During Drop Vertical Jump in ACL Injuries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mahidol University
    Collaborators
    Thammasat University, Liverpool John Moores University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Cruciate Ligament Injury

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kinesio Tape
    Arm Type
    Experimental
    Arm Description
    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 .
    Arm Title
    Control tape
    Arm Type
    Sham Comparator
    Arm Description
    Apply tape in same technique without tension.
    Intervention Type
    Device
    Intervention Name(s)
    Kinesio tape
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Control tape
    Intervention Description
    Apply tape in same technique without tension.
    Primary Outcome Measure Information:
    Title
    Knee joint motion
    Description
    Knee joint angle and moment at initial contact and weight acceptance phase Flexion - Extension Adduction - Abduction Internal - External rotation
    Time Frame
    6 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wat Limruengrangrat, PhD
    Organizational Affiliation
    Collage of Sports Sciences and Technology, Mahidol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21169080
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23084264
    Citation
    Beldame 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.
    Results Reference
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    PubMed Identifier
    22163089
    Citation
    Bjornaraa 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.
    Results Reference
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    PubMed Identifier
    14523314
    Citation
    Ford 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.
    Results Reference
    background
    PubMed Identifier
    15722287
    Citation
    Hewett 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.
    Results Reference
    background
    PubMed Identifier
    16005555
    Citation
    McLean 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, Avon). 2005 Oct;20(8):863-70. doi: 10.1016/j.clinbiomech.2005.05.007.
    Results Reference
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    PubMed Identifier
    16162987
    Citation
    Swirtun 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.
    Results Reference
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    Effects of Elastic Therapeutic Tape on Biomechanical Changes of Knee Joint During Drop Vertical Jump in ACL Injuries

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