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The Effects of Kinesio Tape® on Arthrogenic Muscle Inhibition and Rate of Torque Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03472924
Recruitment Status : Terminated (Insufficient recruitment and enrollment. Reduction in study personnel capacity.)
First Posted : March 21, 2018
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Oregon State University

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE March 21, 2018
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE April 16, 2018
Actual Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
  • Central Activation Ratio [ Time Frame: Change between baseline and 2 days post-intervention ]
    Ratio between maximal voluntary evertor torque and torque produced following the application of an exogenous electrical stimulus
  • Rate of Torque Development [ Time Frame: Change between baseline and 2 days post-intervention ]
    Measure of explosive strength determined by placing a line of best fit to a recorded torque-time curve
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
Maximal Voluntary Isometric Contraction [ Time Frame: Change between baseline and 2 days post-intervention ]
Measure of maximal voluntary isometric torque that participant can produce
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Kinesio Tape® on Arthrogenic Muscle Inhibition and Rate of Torque Development
Official Title  ICMJE The Effects of Kinesio Tape® on Arthrogenic Muscle Inhibition and Rate of Torque Development
Brief Summary This study evaluates whether the use of Kinesio Tape® in combination with a standard exercise program improves muscle function in individuals with chronic ankle instability. Twenty participants will receive Kinesio Tape® and perform an ankle exercise program, while twenty will perform the ankle exercise program without Kinesio Tape®.
Detailed Description

Decreased ability to voluntarily activate the entire motoneuron (MN) pool following joint injury is known as arthrogenic muscle inhibition (AMI), which is commonly quantified by measuring central activation ratio (CAR). AMI is not only observed immediately after joint injury, but has been shown to persist during and after rehabilitation. It is proposed that AMI, by negatively impacting neuromuscular factors such as muscle strength, muscle activation, and rate of torque development (RTD), contributes to a prolonged rehabilitation process and higher risk of re-injury. Unfortunately, AMI cannot be reduced by traditional rehabilitation interventions such as strength training alone. Therefore, it is necessary to identify an intervention that can effectively decrease AMI in order to facilitate improvements in muscle function in individuals with AMI.

Kinesio Tape® is commonly used to facilitate muscle contraction in athletic populations. This elastic therapeutic tape is popular in the athletic setting because it can be applied and used continually during exercise and activities of daily living for up to 2-3 days without restricting movement. It has been suggested that Kinesio Tape® facilitates muscle contraction by inducing increased sensory input via skin stimulation. The tape activates cutaneous mechanoreceptors with the greater afferent feedback thought to improve the efferent output from the central nervous system to the target muscles. While this technique is widely used in the clinical setting to improve muscle function, the facilitative effect of Kinesio Tape® has not been demonstrated- perhaps due to three key limitations of previous investigations. First, previous studies have predominantly recruited healthy participants without muscle function deficits. Therefore, there could have been a ceiling effect whereby there was no observable effect of Kinesio Tape® due to a lack of muscle dysfunction in these healthy individuals. Second, most investigators have generally taken outcome measurements immediately before Kinesio Tape® application and less than 24 hours later. This is much shorter than the 2-3 days that Kinesio Tape® is used clinically and may not be long enough to induce an observable, facilitative effect. Finally, the protocols utilized in previous investigations also failed to mimic clinical practice by not combining Kinesio Tape® application with a therapeutic exercise protocol targeting the inhibited muscle.

Therefore, the purpose of this study is to investigate the effects of prolonged application (> 48hours) of Kinesio Tape® incorporated with a therapeutic exercise protocol on AMI and muscle function. To do so, we will use the peroneus longus muscle in individuals with functional ankle instability (FAI) as a model, given that AMI has been shown to exist in this muscle in individuals with FAI.

The following specific aims will be tested:

Aim#1. To investigate the effect of prolonged application (> 48hours) of Kinesio Tape® incorporated with a therapeutic exercise protocol on AMI of the peroneus longus in individuals with FAI.

Aim#2. To investigate the effect of prolonged application(> 48hours) of Kinesio Tape® incorporated with a therapeutic exercise protocol on peroneus longus muscle function in individuals with FAI.

Our central hypothesis is that prolonged application of Kinesio Tape® in combination with therapeutic exercise will diminish AMI and improve muscle function of the inhibited peroneus longus muscle.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neural Inhibition
  • Injuries, Ankle
Intervention  ICMJE Device: Kinesiotaping
The application of Kinesio Tape® (kinesiotaping) according to the guidelines provided by the Kinesio Taping Association (Kase, K. 2016). A 5 cm width strip of Kinesio Tape® (Kinesio TEX Products, NKT-050, Japan) will be applied from origin (the head of the fibula) to insertion (the medial cuneiform and first metatarsal) of the peroneus longus in a longitudinal direction. The proximal anchors will be applied without tension, and the Kinesio Tape® placed on approximately 50% stretch before being applied over the peroneus longus and the distal anchor point.
Other Name: Kinesio Tape®
Study Arms  ICMJE
  • Experimental: Kinesio Tape
    Kinesiotaping of the peroneus longus according to the guidelines provided by the Kinesio Taping Association (Kase, K. 2016) followed by standardized set of therapeutic exercises that are commonly implemented in ankle rehabilitation programs.
    Intervention: Device: Kinesiotaping
  • No Intervention: Control
    Baseline measures followed by standardized set of therapeutic exercises that are commonly implemented in ankle rehabilitation programs, but no use of kinesiotape.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 16, 2020)
6
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2018)
70
Actual Study Completion Date  ICMJE June 15, 2020
Actual Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. A history of at least one significant ankle sprain on the involved (injured) limb i. The initial sprain must have occurred at least 12 months prior to the study enrollment ii. Was associated with inflammatory symptoms (pain, swelling, etc.) iii. Created at least one interrupted day of desired physical activity.
  2. The most recent injury on the involved (injured) ankle must have occurred more than 3 months prior to the study enrollment.
  3. A history of the involved (injured) ankle joint 'giving way', and/or recurrent sprain and/or 'feelings of instability' on the involved (injured) limb Participants should report at least 2 episodes of 'giving way' in the 6 months prior to the study enrolment.
  4. Be 18-35 years of age
  5. Have not had a past allergic reaction to Kinesio Tape®

Exclusion Criteria:

  1. Have a history of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves, etc.) in either lower extremity.
  2. Have a history of a fracture in either lower extremity requiring realignment.
  3. Had acute injury to the musculoskeletal structures of other joints of either lower extremity in the previous 3 months which impacted joint integrity and function (i.e., sprains, fractures, etc.) and resulted in at least 1 interrupted day of desired physical activity.
  4. Are not able to be matched according to our group allocation procedure
  5. Have had a past allergic reaction to Kinesio Tape®
  6. Currently display symptoms of an acute sprain including swelling, heat, redness, pain, discoloration, and/or loss of range of motion or function
  7. Any diagnosed vestibular disorder, Charcot-Marie-Tooth disorder, Ehlers-Danlos, or other hereditary nerve, balance or connective tissue disorder
  8. Report a possibility that they may be pregnant as hormonal changes may affect ligamentous laxity
  9. Have suffered more than one ankle sprain on the uninvolved limb
  10. Have had an ankle sprain on the uninvolved limb within the past 12 months
  11. Have episodes of giving way of the ankle on the uninvolved limb besides the single time when they may have sprained this ankle.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03472924
Other Study ID Numbers  ICMJE 7967
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oregon State University
Study Sponsor  ICMJE Oregon State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc F Norcross, PhD Oregon State University
PRS Account Oregon State University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP