NCT04345224

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

December 10, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

April 12, 2022

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

April 7, 2020

Last Update Submit

April 11, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

Dynamic tape

EXPERIMENTAL

The gluteal muscle group will be covered with a dynamic tape.

Other: Dynamic tape

Rigid tape

EXPERIMENTAL

The gluteal muscle group will be covered with a rigid tape.

Other: Rigid tape

Sham tape

SHAM COMPARATOR

The gluteal muscle group will be covered with a paper tape - a sham application.

Other: Sham tape

Interventions

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.

Dynamic 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.

Rigid 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.

Sham tape

Eligibility Criteria

Age19 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • not using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to testing,
  • age - 19-24 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pope John Paul II State School Of Higher Education in Biała Podlaska

Biała Podlaska, 21-500, Poland

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Krystyna Gawlik, Ph.D

    Pope John Paul II State School of Higher Education in Biala Podlaska

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 14, 2020

Study Start

December 10, 2020

Primary Completion

March 29, 2022

Study Completion

March 30, 2022

Last Updated

April 12, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations