Muscle WeaknessNCT04345224
The Effect of Dynamic and Rigid Tape Application on the Asymmetry of the Lower Limbs
A study testing Dynamic tape and Rigid tape in people with Muscle Weakness, run by John Paul II University in Biała Podlaska at 1 site in Poland.
Trial summary
This is a prospective randomized three brachial, single-blinded, placebo-controlled trial, which aims at assessing the impact of the gluteal muscle taping with a dynamic tape and a non-elastic tape on the activation of the gluteal muscles and the distribution of the lower limb load in healthy people. Read more about this study
- Who is it for?
- Ages 19 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Dynamic tape and Rigid tape
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 10 Dec 2020to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- not using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to testing,
- age - 19-24 years old
Who cannot join
- spine, hip, knee or ankle surgery,
- spine, hip, knee or ankle injuries within 6 months before the start of the examination,
- neurological and otolaryngological diseases, which may result in imbalances.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Pope John Paul II State School Of Higher Education in Biała Podlaska
Biała Podlaska, 21-500
About this study
Official title: The Effect of Dynamic and Rigid Tape Application on the Asymmetry of the Lower Limbs in Healthy People
This is a prospective randomized three brachial, single-blinded, placebo-controlled trial, which aims at assessing the impact of the gluteal muscle taping with a dynamic tape and a non-elastic tape on the activation of the gluteal muscles and the distribution of the lower limb load in healthy people.
The study participants will be randomly classified into the following groups: A - dynamic kinesiology taping, B - rigid tape, C - placebo group (sham). Patients will be evaluated three times - before applying the tapes, 30 minutes after applying the tapes and 48 hours after applying the tapes.
Read the detailed description
The gluteus maximus is the largest and strongest muscle in the human body. Its function is primarily to extend the hip joint. The back fibers of the gluteus medius and gluteus minimus muscles provide the additional help. These muscles also perform the functions of abductors and external rotators of the hip joint.
The incorrect strength and activation time of the muscles stabilizing the hip joint result in the disturbed load distribution of the lower limbs. This may cause the overloading of the bone and muscle structures. Disorders of the functions of the external hip rotators and abductors may lead to such health problems as: patellofemoral conflict, ilio-tibial band syndrome or non-specific pains of the hip, knee, sacroiliac and lumbar spine. Neurological diseases, such as stroke, causing paresis of the limbs, accompanied by a decrease or increase in muscle tone and disturbed load distribution, are also an obstacle to gait re-education and limit the efficiency of everyday activities.
Dynamic tapes were created by Kenso Kase MD in Japan. Their characteristic feature is extensibility reaching 130-140 percent. The tape is based on sensory effects on fascia mechanoreceptors. Depending on the slicing technique used, the following effects can be achieved: the activation or reduction of muscle tone, the reduction of pain and an increased flow of tissue fluids.
The concept of using a rigid tape was created and developed by Jenny McConnell. A characteristic feature of a rigid tape is the lack of stretchability, thanks to which mechanical stabilization of a specific section of the body can be achieved. The effects of using a rigid tape include: the reduction of pain, the activation or reduction of muscle tone, and the correction of joint components.
For many years, research has been conducted into the effects of using a dynamic tape and a rigid tape on the muscle functions. In many cases, reports from various authors are contradictory. There is also a lack of publications assessing the effect of a tape on the buttock muscle activation and the associated lower limb load distribution. There is therefore a need for further research.
The aim of the project is to assess the impact of gluteal muscle taping with a dynamic tape and a rigid tape on the distribution of lower limb load in healthy people. The confirmation of research hypotheses will allow for the introduction of a new therapy tool in neurological patients (e.g. after stroke), but also healthy people, to prevent a lower limb and spine structures overloading.
- Conditions
- Muscle Weakness
- Being tested
- Dynamic tape, Rigid tape, Sham tape
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic tapeOther
A kinesiology tape will be applied to the lateral hip of the affected side to facilitate the gluteus medius muscle activation while the participant is lying down. The first third of one I-strip will begin at the posterior iliac crest without tension to provide an anchor that will not cross the target tissue. The participant will actively flex the adducted hip to allow for the application of the middle third of the tape with approximately 50 percent tension (able to visualize the wave pattern in the tape). Subsequently, with the leg in the original position, the remainder of the tape will be applied without tension, ending approximately at the greater trochanter. Afterward, the second I-strip will be applied in the same manner starting at the anterior iliac crest.
Rigid tapeOther
The rigid tape will be applied in a standing position. The first tape will be applied from the greater trochanter to the anterior iliac crest. The second from the greater trochanter to the posterior iliac crest. Both tapes are applied with the muscle mass lifted towards the iliac crest.
Sham tapeOther
The control group (sham tape application) will receive a single strip of a Kinesio tape across the lateral affected hip without tension in the tape or muscle stretch.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic tape | Experimental | The gluteal muscle group will be covered with a dynamic tape. Receives: Other: Dynamic tape |
| Rigid tape | Experimental | The gluteal muscle group will be covered with a rigid tape. Receives: Other: Rigid tape |
| Sham tape | Sham comparator | The gluteal muscle group will be covered with a paper tape - a sham application. Receives: Other: Sham tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tests on the dynamographic platform
Assessment of:
- the lower extremity load when standing with eyes open,
- the lower extremity load when standing with eyes closed,
- the lower limb load when walking in place,
- the lower limbs loading when sitting and getting up from a chair. The symmetry index (Ws) will be calculated from the result of each test.The symmetry index calculated as the quotient of the load results of a more heavily loaded limb to a less loaded limb. The correct value of the indicator is taken from 1.0 to 1.15.
Measured: Before applying the tape and after 2 days
Muscle activation test using NaroxonUltium (EMG) - Maximum Voluntary Isometric Contraction (MVIC)
The gluteus medius muscle MVIC will be performed while lying on one's side, with the hip in a neutral rotation and slightly extended and then actively abducted to end range as resistance will be applied just above the ankle.The maximal hip abductor strength will be tested 3 times per leg for each participant.The maximal strength will be defined as the peak force recorded by the digital force gauge.
Measured: Before applying the tape
Muscle activation test using NaroxonUltium (EMG) - Unilateral bridge
Participant is in a supine position with the bilateral knees bent at 90 degrees.Participant lifts the leg and extends it at the knee,then lifts the bilateral hips to the neutral hip position with the right leg only.
The results of the test (the peak force) will be calculated and presented as percentage MVIC.
Measured: Before applying the tape and after 2 days
Muscle activation test using NaroxonUltium (EMG) - Side-lying hip abduction
Participant is lying on their side with the bottom leg bent to keep the body form rotating.The top leg is abducted approximately at 25 degrees, held for 2-3 seconds and adducted to the starting position. The results of the test (the peak force) will be calculated and presented as percentage MVIC.
Measured: Before applying the tape and after 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start10 Dec 2020
- Primary completion29 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies 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
- Model description
- The study participants will be randomly qualified (allocated via a computer program) to the tree groups: A - dynamic tape, B - rigid tape, C - sham tape
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Paul II University in Biała Podlaska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krystyna Gawlik, Ph.D, Study chair, Pope John Paul II State School of Higher Education in Biala Podlaska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345224
- Sponsor's protocol ID
- PopeJohnPaulIIStateSchHigherE1
- Status last verified
- Mar 2021
- First submitted
- 7 Apr 2020
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dynamic and Rigid Tape Application on the Asymmetry of the Lower Limbs in Healthy People
- ClinicalTrials.gov ID
- NCT04345224
- Acronym / sponsor ID
- PopeJohnPaulIIStateSchHigherE1
- Conditions
- Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- John Paul II University in Biała PodlaskaUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized three brachial, single-blinded, placebo-controlled trial, which aims at assessing the impact of the gluteal muscle taping with a dynamic tape and a non-elastic tape on the activation of the gluteal muscles and the distribution of the lower limb load in healthy people.
The study participants will be randomly classified into the following groups: A - dynamic kinesiology taping, B - rigid tape, C - placebo group (sham). Patients will be evaluated three times - before applying the tapes, 30 minutes after applying the tapes and 48 hours after applying the tapes.
Detailed description
The gluteus maximus is the largest and strongest muscle in the human body. Its function is primarily to extend the hip joint. The back fibers of the gluteus medius and gluteus minimus muscles provide the additional help. These muscles also perform the functions of abductors and external rotators of the hip joint.
The incorrect strength and activation time of the muscles stabilizing the hip joint result in the disturbed load distribution of the lower limbs. This may cause the overloading of the bone and muscle structures. Disorders of the functions of the external hip rotators and abductors may lead to such health problems as: patellofemoral conflict, ilio-tibial band syndrome or non-specific pains of the hip, knee, sacroiliac and lumbar spine. Neurological diseases, such as stroke, causing paresis of the limbs, accompanied by a decrease or increase in muscle tone and disturbed load distribution, are also an obstacle to gait re-education and limit the efficiency of everyday activities.
Dynamic tapes were created by Kenso Kase MD in Japan. Their characteristic feature is extensibility reaching 130-140 percent. The tape is based on sensory effects on fascia mechanoreceptors. Depending on the slicing technique used, the following effects can be achieved: the activation or reduction of muscle tone, the reduction of pain and an increased flow of tissue fluids.
The concept of using a rigid tape was created and developed by Jenny McConnell. A characteristic feature of a rigid tape is the lack of stretchability, thanks to which mechanical stabilization of a specific section of the body can be achieved. The effects of using a rigid tape include: the reduction of pain, the activation or reduction of muscle tone, and the correction of joint components.
For many years, research has been conducted into the effects of using a dynamic tape and a rigid tape on the muscle functions. In many cases, reports from various authors are contradictory. There is also a lack of publications assessing the effect of a tape on the buttock muscle activation and the associated lower limb load distribution. There is therefore a need for further research.
The aim of the project is to assess the impact of gluteal muscle taping with a dynamic tape and a rigid tape on the distribution of lower limb load in healthy people. The confirmation of research hypotheses will allow for the introduction of a new therapy tool in neurological patients (e.g. after stroke), but also healthy people, to prevent a lower limb and spine structures overloading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The study participants will be randomly qualified (allocated via a computer program) to the tree groups: A - dynamic tape, B - rigid tape, C - sham tape
| Arm | Type | Receives |
|---|---|---|
| Dynamic tape | Experimental | Other: Dynamic tapeThe gluteal muscle group will be covered with a dynamic tape. |
| Rigid tape | Experimental | Other: Rigid tapeThe gluteal muscle group will be covered with a rigid tape. |
| Sham tape | Sham comparator | Other: Sham tapeThe gluteal muscle group will be covered with a paper tape - a sham application. |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- not using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to testing,
- age - 19-24 years old
Key exclusion criteria (3 listed)
- spine, hip, knee or ankle surgery,
- spine, hip, knee or ankle injuries within 6 months before the start of the examination,
- neurological and otolaryngological diseases, which may result in imbalances.
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 |
|---|---|---|
| Dynamic tapeA kinesiology tape will be applied to the lateral hip of the affected side to facilitate the gluteus medius muscle activation while the participant is lying down. The first third of one I-strip will begin at the posterior iliac crest without tension to provide an anchor that will not cross the target tissue. The participant will actively flex the adducted hip to allow for the application of the middle third of the tape with approximately 50 percent tension (able to visualize the wave pattern in the tape). Subsequently, with the leg in the original position, the remainder of the tape will be applied without tension, ending approximately at the greater trochanter. Afterward, the second I-strip will be applied in the same manner starting at the anterior iliac crest. | Other | Dynamic tape |
| Rigid tapeThe rigid tape will be applied in a standing position. The first tape will be applied from the greater trochanter to the anterior iliac crest. The second from the greater trochanter to the posterior iliac crest. Both tapes are applied with the muscle mass lifted towards the iliac crest. | Other | Rigid tape |
| Sham tapeThe control group (sham tape application) will receive a single strip of a Kinesio tape across the lateral affected hip without tension in the tape or muscle stretch. | Other | Sham tape |
Primary outcome
Tests on the dynamographic platform
Time frame: Before applying the tape and after 2 days
Assessment of: * the lower extremity load when standing with eyes open, * the lower extremity load when standing with eyes closed, * the lower limb load when walking in place, * the lower limbs loading when sitting and getting up from a chair. The symmetry index (Ws) will be calculated from the result of each test.The symmetry index calculated as the quotient of the load results of a more heavily loaded limb to a less loaded limb. The correct value of the indicator is taken from 1.0 to 1.15.
Muscle activation test using NaroxonUltium (EMG) - Maximum Voluntary Isometric Contraction (MVIC)
Time frame: Before applying the tape
The gluteus medius muscle MVIC will be performed while lying on one's side, with the hip in a neutral rotation and slightly extended and then actively abducted to end range as resistance will be applied just above the ankle.The maximal hip abductor strength will be tested 3 times per leg for each participant.The maximal strength will be defined as the peak force recorded by the digital force gauge.
Muscle activation test using NaroxonUltium (EMG) - Unilateral bridge
Time frame: Before applying the tape and after 2 days
Participant is in a supine position with the bilateral knees bent at 90 degrees.Participant lifts the leg and extends it at the knee,then lifts the bilateral hips to the neutral hip position with the right leg only. The results of the test (the peak force) will be calculated and presented as percentage MVIC.
Muscle activation test using NaroxonUltium (EMG) - Side-lying hip abduction
Time frame: Before applying the tape and after 2 days
Participant is lying on their side with the bottom leg bent to keep the body form rotating.The top leg is abducted approximately at 25 degrees, held for 2-3 seconds and adducted to the starting position. The results of the test (the peak force) will be calculated and presented as percentage MVIC.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- 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.
Krystyna Gawlik, Ph.D study chair
Pope John Paul II State School of Higher Education in Biala Podlaska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic tape and Rigid tape in people with Muscle Weakness, run by John Paul II University in Biała Podlaska at 1 site in Poland.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 12 Apr 2022. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tests on the dynamographic platform (time frame: Before applying the tape and after 2 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2022.