Neural InhibitionNCT03472924
The Effects of Kinesio Tape® on Arthrogenic Muscle Inhibition and Rate of Torque Development
A study testing Kinesiotaping in people with Neural Inhibition and Injuries, Ankle, run by Oregon State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Neural Inhibition, Injuries, Ankle
- What is being tested?
- Kinesiotaping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2018to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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®
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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®.
Read the 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.
- Conditions
- Neural Inhibition, Injuries, Ankle
- Being tested
- Kinesiotaping
- Keywords
- AMI
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingDevice
Also called Kinesio Tape®
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.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Tape | Experimental | 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. Receives: Device: Kinesiotaping |
| Control | No intervention | Baseline measures followed by standardized set of therapeutic exercises that are commonly implemented in ankle rehabilitation programs, but no use of kinesiotape. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Central Activation Ratio
Ratio between maximal voluntary evertor torque and torque produced following the application of an exogenous electrical stimulus
Measured: Change between baseline and 2 days post-intervention
Change in Rate of Torque Development
Measure of explosive strength determined by placing a line of best fit to a recorded torque-time curve from onset to 100ms after onset
Measured: Change between baseline and 2 days post-intervention
Secondary outcomes (1)
Change in Maximal Voluntary Isometric Contraction
Measure of maximal voluntary isometric torque that participant can produce
Measured: Change between baseline and 2 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start16 Apr 2018
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Why it stopped: Insufficient recruitment and enrollment. Reduction in study personnel capacity.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neural InhibitionStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Norcross, Oregon State University
- Investigators
- Marc F Norcross, PhD, Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472924
- Sponsor's protocol ID
- 7967
- Status last verified
- Feb 2024
- First submitted
- 14 Mar 2018
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22032998Yoshida 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.
PubMed 17578750McVey 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.
PubMed 16390639
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Kinesio Tape® on Arthrogenic Muscle Inhibition and Rate of Torque Development
- ClinicalTrials.gov ID
- NCT03472924
- Acronym / sponsor ID
- 7967
- Conditions
- Neural Inhibition, Injuries, Ankle
- Keywords
- AMI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment and enrollment. Reduction in study personnel capacity.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio Tape | Experimental | Device: KinesiotapingKinesiotaping 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. |
| Control | No intervention | –Baseline measures followed by standardized set of therapeutic exercises that are commonly implemented in ankle rehabilitation programs, but no use of kinesiotape. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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®
Key exclusion criteria (11 listed)
- 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®
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 |
|---|---|---|
| KinesiotapingAlso: Kinesio Tape®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. | Device | Kinesio Tape |
Primary outcome
Change in 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
Change in 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 from onset to 100ms after onset
1 secondary outcome
Change in Maximal Voluntary Isometric Contraction
Time frame: Change between baseline and 2 days post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22032998Akbas 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.
- Background: PubMed 17578750Yoshida 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.
- Background: PubMed 16390639McVey 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.
- 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.
Marc F Norcross, PhD principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping in people with Neural Inhibition and Injuries, Ankle, run by Oregon 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Central Activation Ratio (time frame: Change between baseline and 2 days post-intervention). The study lists 2 primary outcomes in all. 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 NCT03472924, which also lists 3 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 19 Mar 2024.