Healthy SubjectsNCT02318264
Influence of Elastic Tape on Activation of the Quadriceps Muscle During Selected Resisted and Weight Bearing Exercises
A study testing Kinesio Tape in people with Healthy Subjects and Changes Based on Duration of Tape Application, run by State University of New York - Upstate Medical University.
Trial summary
This cross over design study will be used to determine the influence of elastic kinesiology tape on the speed and amplitude of quadriceps activation (anterior thigh) during selected resisted and weight bearing exercises. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Changes Based on Duration of Tape Application, Direction of Kinesio Tape Application
- What is being tested?
- Kinesio Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2016
- 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
- Healthy volunteers accepted
- Adult
Eligible participants were between the ages of 18 to 35 and naïve to the use of kinesiology tape. Exclusion criteria included musculoskeletal injury to the lower extremities (within the previous year), past surgery to the lower extremities, or known allergy to adhesive tape.
All participants were screened for physical activity and exercise testing using the Physical Activity and Readiness Questionnaire (PAR-Q)15 (British Columbia Ministry of Health, British Columbia/Canada), resting vital signs, and American College of Sports Medicine guidelines for exercise testing. The Physical Activity and Readiness Questionnaire (PAR-Q)(British Columbia Ministry of Health) will be used as a general screen of exercise safety. Additionally, researchers will ask participants to identify possible cardiovascular and/or orthopedic risks to resistance exercise, dominant leg injuries/surgeries, and regarding history or familiarity of elastic tape. Subjects who are at risk due to recent (within the last year) musculoskeletal injury to lower extremities will be excluded from the study. Additionally, we will exclude subjects who report significant respiratory-cardiovascular disease, subjects with a history of surgery on their dominant leg, or individuals who have been trained in elastic tape theory and application. Any participant with a known allergy to adhesives will also be excluded from the study. Blood pressure and heart rate will be measured at the start of each session. Per ACSM's guidelines for exercise testing, if a participant's resting systolic blood pressure is greater than >200 mm Hg or diastolic BP is >110 mm Hg then he/she will be excluded from exercise testing and the study
About this study
This cross over design study will be used to determine the influence of elastic kinesiology tape on the speed and amplitude of quadriceps activation (anterior thigh) during selected resisted and weight bearing exercises.
Read the detailed description
Objective: This cross over design study will be used to determine the influence of elastic kinesiology tape on the speed and amplitude of quadriceps activation (anterior thigh) during selected resisted and weight bearing exercises.
Background: Compliant tape, such as KiniseoⓇ Tape (KT), is highly elastic and claimed by the manufacturer to mimic skin. It is commonly used by physical therapists and sports medicine practitioners to treat musculoskeletal conditions and to enhance physical performance. The creators of KT teach a variety of applications techniques to affect the underlying musculature. Current theory regarding elastic tape application suggests that if the tape is applied over a muscle from the proximal to distal attachments, it will facilitate the underlying muscle while applying the tape from distal to proximal will inhibit the musculature.1 While studies have investigated the effect of elastic tape on muscle activation, few studies to date have compared the direction of application on muscle activation.2-7
Methods and Measures: Healthy subjects between 18-35 years old will be recruited from the Upstate Medical University community via email and word of mouth. Potential participants will report to the Institute for Human Performance and will be asked to complete all documentation including informed consent and a health-screening questionnaire. If eligible, qualified participants will perform 2 functional jumping exercises (vertical jump and single-leg triple hop for distance) 8 and isokinetic knee flexion and extension at 60 degrees/sec and 120 degrees/sec using the Biodex System 3 Pro Dynamometer (Biodex Medical Systems, Shirley, NY). The Biodex isokinetic machine has been shown to be a reliable and valid source of measuring peak torque, position and velocity.9 Surface electromyography (EMG) recordings will be collected from the vastus medialis and vastus lateralis during isokinetic testing. Testing will occur over four sessions. In the first session, baseline measurements and measurements immediately after KT application will be collected. In the second session, the participant will be retested after wearing the KT for up to two days (48 hours). This process will be repeated one week later during sessions three and four with KT applied in the opposite direction of the initial testing condition. KT application direction and the order of activities will be randomized for each participant.
- Conditions
- Healthy Subjects, Changes Based on Duration of Tape Application, Direction of Kinesio Tape Application
- Being tested
- Kinesio Tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapeDevice
Elastic tape placed over the skin
| Study group | Role | What they receive |
|---|---|---|
| Distal to Proximal Tape | Experimental | Quadriceps muscle taped (Using Kinesio Tape) starting distal by knee and ending proximal by hip. Receives: Device: Kinesio Tape |
| Proximal to Distal Tape | Experimental | Quadriceps muscle taped (Using Kinesio Tape) starting proximal by hip and ending distal by knee. Receives: Device: Kinesio Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical Jump Height Immediately Post Tape Administration
Vertical Jump Height Immediately Post Tape Administration
Measured: Immediate
Unilateral Three Hop for Distance Immediately Post Tape Administration
Unilateral three hop for distance immediately post tape administration
Measured: Immediate
Secondary outcomes (4)
EMG During Isokinetic Testing at 120 Degrees/Sec Immediately Post Tape Application
EMG data were collected during the isokinetic testing at 120 degrees/sec Immediately Post Tape Application
Measured: Immediate
EMG During Isokinetic Testing at 60 Degrees/Sec Immediately Post Tape Application
EMG during isokinetic testing at 60 degrees/second Immediately Post Tape Application
Measured: Immediate
Isokinetic Torque at 120 Degrees/Sec Immediately Post Tape Administration
Isokinetic Torque at 120 Degrees/Second Immediately Post Tape Administration
Measured: Immediate
Isokinetic Torque at 60 Degrees/Sec Immediately Post Tape Administration
Isokinetic Torque at 60 Degrees/Second Immediately Post Tape Administration
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionMay 2016
- Study completionDec 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Dolphin, State University of New York - Upstate Medical University
- Investigators
- Michelle Dolphin, DPT, Principal investigator, SUNY Upstate Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318264
- Sponsor's protocol ID
- SUMU-PT-KTAP1
- Status last verified
- May 2022
- First submitted
- 9 Dec 2014
- Last updated
- 14 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No individual participant data will be shared.
Publications
Dolphin M, Brooks G, Calancie B, Rufa A. Does the Direction of Kinesiology Tape Application Influence Muscle Activation in Asymptomatic Individuals? Int J Sports Phys Ther. 2021 Feb 1;16(1):135-144. doi: 10.26603/001c.18799.
PubMed 33604143
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Elastic Tape on Activation of the Quadriceps Muscle During Selected Resisted and Weight Bearing Exercises
- ClinicalTrials.gov ID
- NCT02318264
- Acronym / sponsor ID
- SUMU-PT-KTAP1
- Conditions
- Healthy Subjects, Changes Based on Duration of Tape Application, Direction of Kinesio Tape Application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Posted 19 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cross over design study will be used to determine the influence of elastic kinesiology tape on the speed and amplitude of quadriceps activation (anterior thigh) during selected resisted and weight bearing exercises.
Detailed description
Objective: This cross over design study will be used to determine the influence of elastic kinesiology tape on the speed and amplitude of quadriceps activation (anterior thigh) during selected resisted and weight bearing exercises.
Background: Compliant tape, such as KiniseoⓇ Tape (KT), is highly elastic and claimed by the manufacturer to mimic skin. It is commonly used by physical therapists and sports medicine practitioners to treat musculoskeletal conditions and to enhance physical performance. The creators of KT teach a variety of applications techniques to affect the underlying musculature. Current theory regarding elastic tape application suggests that if the tape is applied over a muscle from the proximal to distal attachments, it will facilitate the underlying muscle while applying the tape from distal to proximal will inhibit the musculature.1 While studies have investigated the effect of elastic tape on muscle activation, few studies to date have compared the direction of application on muscle activation.2-7
Methods and Measures: Healthy subjects between 18-35 years old will be recruited from the Upstate Medical University community via email and word of mouth. Potential participants will report to the Institute for Human Performance and will be asked to complete all documentation including informed consent and a health-screening questionnaire. If eligible, qualified participants will perform 2 functional jumping exercises (vertical jump and single-leg triple hop for distance) 8 and isokinetic knee flexion and extension at 60 degrees/sec and 120 degrees/sec using the Biodex System 3 Pro Dynamometer (Biodex Medical Systems, Shirley, NY). The Biodex isokinetic machine has been shown to be a reliable and valid source of measuring peak torque, position and velocity.9 Surface electromyography (EMG) recordings will be collected from the vastus medialis and vastus lateralis during isokinetic testing. Testing will occur over four sessions. In the first session, baseline measurements and measurements immediately after KT application will be collected. In the second session, the participant will be retested after wearing the KT for up to two days (48 hours). This process will be repeated one week later during sessions three and four with KT applied in the opposite direction of the initial testing condition. KT application direction and the order of activities will be randomized for each participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal to Proximal Tape | Experimental | Device: Kinesio TapeQuadriceps muscle taped (Using Kinesio Tape) starting distal by knee and ending proximal by hip. |
| Proximal to Distal Tape | Experimental | Device: Kinesio TapeQuadriceps muscle taped (Using Kinesio Tape) starting proximal by hip and ending distal by knee. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 tape placed over the skin | Device | Distal to Proximal Tape, Proximal to Distal Tape |
Primary outcome
Vertical Jump Height Immediately Post Tape Administration
Time frame: Immediate
Vertical Jump Height Immediately Post Tape Administration
Unilateral Three Hop for Distance Immediately Post Tape Administration
Time frame: Immediate
Unilateral three hop for distance immediately post tape administration
4 secondary outcomes
EMG During Isokinetic Testing at 120 Degrees/Sec Immediately Post Tape Application
Time frame: Immediate
EMG During Isokinetic Testing at 60 Degrees/Sec Immediately Post Tape Application
Time frame: Immediate
Isokinetic Torque at 120 Degrees/Sec Immediately Post Tape Administration
Time frame: Immediate
Isokinetic Torque at 60 Degrees/Sec Immediately Post Tape Administration
Time frame: Immediate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33604143Dolphin M, Brooks G, Calancie B, Rufa A. Does the Direction of Kinesiology Tape Application Influence Muscle Activation in Asymptomatic Individuals? Int J Sports Phys Ther. 2021 Feb 1;16(1):135-144. doi: 10.26603/001c.18799.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
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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.
Michelle Dolphin, DPT principal investigator
SUNY Upstate Medical
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Tape in people with Healthy Subjects and Changes Based on Duration of Tape Application, run by State University of New York - Upstate Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Jun 2022. 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. 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 May 2022). 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?
Vertical Jump Height Immediately Post Tape Administration (time frame: Immediate). 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 NCT02318264, which also lists 1 linked publication.
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 14 Jun 2022.