The Effects of Kinesio Tape® on Arthrogenic Muscle Inhibition and Rate of Torque Development
Primary Purpose
Neural Inhibition, Injuries, Ankle
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kinesiotaping
Sponsored by
About this trial
This is an interventional treatment trial for Neural Inhibition focused on measuring AMI
Eligibility Criteria
Inclusion Criteria:
- 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.
- The most recent injury on the involved (injured) ankle must have occurred more than 3 months prior to the study enrollment.
- 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.
- Be 18-35 years of age
- Have not had a past allergic reaction to Kinesio Tape®
Exclusion Criteria:
- Have a history of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves, etc.) in either lower extremity.
- Have a history of a fracture in either lower extremity requiring realignment.
- 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.
- Are not able to be matched according to our group allocation procedure
- Have had a past allergic reaction to Kinesio Tape®
- Currently display symptoms of an acute sprain including swelling, heat, redness, pain, discoloration, and/or loss of range of motion or function
- Any diagnosed vestibular disorder, Charcot-Marie-Tooth disorder, Ehlers-Danlos, or other hereditary nerve, balance or connective tissue disorder
- Report a possibility that they may be pregnant as hormonal changes may affect ligamentous laxity
- Have suffered more than one ankle sprain on the uninvolved limb
- Have had an ankle sprain on the uninvolved limb within the past 12 months
- Have episodes of giving way of the ankle on the uninvolved limb besides the single time when they may have sprained this ankle.
Sites / Locations
- Oregon State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Kinesio Tape
Control
Arm Description
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.
Baseline measures followed by standardized set of therapeutic exercises that are commonly implemented in ankle rehabilitation programs, but no use of kinesiotape.
Outcomes
Primary Outcome Measures
Central Activation Ratio
Ratio between maximal voluntary evertor torque and torque produced following the application of an exogenous electrical stimulus
Rate of Torque Development
Measure of explosive strength determined by placing a line of best fit to a recorded torque-time curve
Secondary Outcome Measures
Maximal Voluntary Isometric Contraction
Measure of maximal voluntary isometric torque that participant can produce
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03472924
Brief Title
The Effects of Kinesio Tape® on Arthrogenic Muscle Inhibition and Rate of Torque Development
Official Title
The Effects of Kinesio Tape® on Arthrogenic Muscle Inhibition and Rate of Torque Development
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment and enrollment. Reduction in study personnel capacity.
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon State University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neural Inhibition, Injuries, Ankle
Keywords
AMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kinesio Tape
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Baseline measures followed by standardized set of therapeutic exercises that are commonly implemented in ankle rehabilitation programs, but no use of kinesiotape.
Intervention Type
Device
Intervention Name(s)
Kinesiotaping
Other Intervention Name(s)
Kinesio Tape®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Central Activation Ratio
Description
Ratio between maximal voluntary evertor torque and torque produced following the application of an exogenous electrical stimulus
Time Frame
Change between baseline and 2 days post-intervention
Title
Rate of Torque Development
Description
Measure of explosive strength determined by placing a line of best fit to a recorded torque-time curve
Time Frame
Change between baseline and 2 days post-intervention
Secondary Outcome Measure Information:
Title
Maximal Voluntary Isometric Contraction
Description
Measure of maximal voluntary isometric torque that participant can produce
Time Frame
Change between baseline and 2 days post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
The most recent injury on the involved (injured) ankle must have occurred more than 3 months prior to the study enrollment.
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.
Be 18-35 years of age
Have not had a past allergic reaction to Kinesio Tape®
Exclusion Criteria:
Have a history of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves, etc.) in either lower extremity.
Have a history of a fracture in either lower extremity requiring realignment.
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.
Are not able to be matched according to our group allocation procedure
Have had a past allergic reaction to Kinesio Tape®
Currently display symptoms of an acute sprain including swelling, heat, redness, pain, discoloration, and/or loss of range of motion or function
Any diagnosed vestibular disorder, Charcot-Marie-Tooth disorder, Ehlers-Danlos, or other hereditary nerve, balance or connective tissue disorder
Report a possibility that they may be pregnant as hormonal changes may affect ligamentous laxity
Have suffered more than one ankle sprain on the uninvolved limb
Have had an ankle sprain on the uninvolved limb within the past 12 months
Have episodes of giving way of the ankle on the uninvolved limb besides the single time when they may have sprained this ankle.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc F Norcross, PhD
Organizational Affiliation
Oregon State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon State University
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97331
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22032998
Citation
Akbas E, Atay AO, Yuksel I. The effects of additional kinesio taping over exercise in the treatment of patellofemoral pain syndrome. Acta Orthop Traumatol Turc. 2011;45(5):335-41. doi: 10.3944/AOTT.2011.2403. Erratum In: Acta Orthop Traumatol Turc. 2011;45(6):471.
Results Reference
background
PubMed Identifier
17578750
Citation
Yoshida A, Kahanov L. The effect of kinesio taping on lower trunk range of motions. Res Sports Med. 2007 Apr-Jun;15(2):103-12. doi: 10.1080/15438620701405206.
Results Reference
background
PubMed Identifier
16390639
Citation
McVey ED, Palmieri RM, Docherty CL, Zinder SM, Ingersoll CD. Arthrogenic muscle inhibition in the leg muscles of subjects exhibiting functional ankle instability. Foot Ankle Int. 2005 Dec;26(12):1055-61. doi: 10.1177/107110070502601210.
Results Reference
background
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The Effects of Kinesio Tape® on Arthrogenic Muscle Inhibition and Rate of Torque Development
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