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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04345224
Other study ID # PopeJohnPaulIIStateSchHigherE1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 10, 2020
Est. completion date March 30, 2022

Study information

Verified date March 2021
Source John Paul II University of Applied Sciences in Biala Podlaska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date March 30, 2022
Est. primary completion date March 29, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 24 Years
Eligibility Inclusion Criteria: - not using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to testing, - age - 19-24 years old Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dynamic tape
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 tape
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 tape
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.

Locations

Country Name City State
Poland Pope John Paul II State School Of Higher Education in Biala Podlaska Biala Podlaska

Sponsors (1)

Lead Sponsor Collaborator
John Paul II University of Applied Sciences in Biala Podlaska

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Before applying the tape and after 2 days
Primary 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. Before applying the tape
Primary 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.
Before applying the tape and after 2 days
Primary 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. Before applying the tape and after 2 days
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