NCT04888520

Brief Summary

It is a controlled and randomized clinical trial with the objective of verifying the acute and chronic effects (8 weeks) of elastic banding in runners. Thus, we have as hypotheses of this research: The elastic bandage indirectly influences the muscular strength to the extent that it supposedly can alter the muscular activation verified through the surface electromyography in individuals submitted to the training as the running training. The elastic bandage has clinical significance, however, it does not present statistical significance on muscle strength and activation in individuals submitted to training as running training. To confirm these hypotheses, the muscle strength of the flexors and extensors of the right knee will be checked by means of the isokinetic dynamometer and the muscular activation of the extensors of the right knee (rectus femoris muscle) will be assessed by means of surface electromyography. The elastic bandage will be applied according to a specific protocol in "I" over the muscular belly of the right femoral rectus muscle (which will be submitted to evaluations). All participants will be evaluated without applying adhesive tape and will receive the first application of the tape without tension. Then, after 20 minutes of rest, they will be reassessed with the tape. Participants will be randomized into two groups and both will receive the adhesive tape (with or without tension according to randomization). Then the evaluations will be repeated (all will be reevaluated without the tape and with the tape (with or without tension according to the protocol).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Status
unknown

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

January 6, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

May 17, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

January 6, 2021

Last Update Submit

May 12, 2021

Conditions

Keywords

Muscle strengthPeak TorqueElectromyographyAthletes

Outcome Measures

Primary Outcomes (1)

  • Change in muscle strength of the rectus femoris muscle after 8 weeks of application of the elastic bandage

    The dynamometer must be properly calibrated and the evaluation will be carried out with the participant seated and stabilized in the chair with a hip flexion of 85°, with a belt positioned horizontally in the pelvic region and two crossed belts in front of the trunk, in the thoracic region, while another belt will stabilize the thigh of the lower limb contralateral to the evaluated limb. The equipment's rotation axis must be aligned parallel to the axis of the evaluated knee joint (lateral epicondyle), and the lower limb will be fixed to the dynamometer lever arm, with the support pad two centimeters from the heel. The participant will have a brief familiarization with the equipment. They will have visual feedback on the monitor screen. 4 evaluation moments: 2 initial (without elastic bandage; and with elastic bandage, but without tension applied to the elastic bandage); 2 final (without elastic bandage; and with elastic bandage-with or without tension, according to the randomization)

    Initial evaluation will be followed by 8 weeks of intervention with the use of elastic bandage and in the last week the reevaluation will be carried out.

Secondary Outcomes (1)

  • Changes in activation of the rectus femoris muscle (surface electromyography) after 8 weeks of intervention with elastic bandage

    Initial evaluation will be followed by 8 weeks of intervention with the use of elastic bandage and in the last week the reevaluation will be carried out.

Study Arms (2)

Tensioning protocol of the elastic bandage (WT)

EXPERIMENTAL

The group will have progressive tension throughout the week - based on the reduction of the tape in relation to the size of the applied area (which will always be the same), which generates a longitudinal tension of the tape in relation to the participant's skin. The Therapy Tex® brand has the elastic deformation capability of up to 40%. The tensioning protocol of the elastic bandage will work with 20% of the elastic deformation capacity of the bandage. The tension will be given from point A to point B in order to generate excitatory stimuli. The percentage of 20% reduction in tension will be distributed over the 7 weeks of intervention, and the first week of the protocol included application without tension. The tape reduction will be controlled by the formula: (size of the application area on the skin\*20% /7 weeks= size of the tape to be cut in each of the 7 applications starting from the second week. Tape size and tape application area will be calculated in centimeters (cm).

Device: Adhesive elastic bandage

Free tension

PLACEBO COMPARATOR

The group will have no tension in any of its tape applications; that way the size of the tape over the applied area will always be the same.

Device: Adhesive elastic bandage

Interventions

The base of the tape should be applied 5 cm below the origin of the rectus femoris (lower anterior iliac spine), going towards its insertion (base of the patella, through supra-patellar ligament), without tension in this part of the tape (2 to 3 cm initial) in order to avoid discomfort. The application mode will be in "I" ("I-strip"). The participants will be in the supine position, with the hip flexed at 30° and the knee flexed at 60°. The applications of the tape will be carried out every Monday, before the first day of running training of the week and should remain until Friday, when it will be removed by the researcher after the last day of running training of the week. If the elastic bandage unstuck alone from the skin before this period, the event should be immediately reported to the therapist.

Also known as: Kinesio Tape, Kinesio Taping, Kinesiotape, Kinesiotaping, Functional elastic bandage
Free tensionTensioning protocol of the elastic bandage (WT)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being between 18 and 60 years old;
  • being physically able to participate in the experimental study;
  • being completely independent in carrying out basic activities of daily living;
  • not having a physical, hearing or visual impairment that prevents the exams from being performed or making use of prostheses or orthopedic orthoses;
  • having no history of injury to the knee, ankle or hip;
  • has no allergy to elastic bandages;
  • having time to participate in the interventions;
  • has no cognitive impairment according to the Mini Mental State Examination (MMSE);
  • has a training frequency of at least twice a week for more than three months.

You may not qualify if:

  • Participants who fail to complete evaluations and/or interventions for any reason
  • Participants who, for some reason, decide to withdraw consent for the research will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Athletic Tape

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Marieli R Stocco, PhD Student

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marieli R Stocco, PhD Student

CONTACT

Rodrigo Antonio C Andraus, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All participants will receive the intervention (application of elastic bandage) and will be blind to which of the two groups belongs. All interventions will be carried out in a private room, one participant at a time. The evaluators (initial and final) and the researcher responsible for analyzing the results will also be blind to the conditions of the groups analyzed. However, the professional who applies the intervention will have knowledge of which group each participant belongs to based on the process of randomizing the participants into two groups. Randomization will be performed by a collaborator not involved in the research.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The muscle strength of the right knee flexors and extensors will be verified using the isokinetic dynamometer and the muscular activation of the right knee extensors (rectus femoris muscle) will be assessed using surface electromyography. The elastic bandage will be applied over the muscular belly of the right rectus femoris muscle. Initially, all participants will be evaluated without tape, immediately receiving it without tension and, after 20 minutes of rest, they will be reassessed. All will be randomized into two groups and both will receive adhesive tape with or without tension in the application. In the eighth and last week, before the last application of the tape, everyone will be reevaluated without the tape. Then, the last application of the adhesive tape will be carried out with or without tension (according to their respective groups) and after 20 minutes of rest, everyone will be evaluated again with the last application of the tape.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Coordinator of Stricto Sensu Program in Rehabilitation Sciences

Study Record Dates

First Submitted

January 6, 2021

First Posted

May 17, 2021

Study Start

June 1, 2021

Primary Completion

August 1, 2021

Study Completion

September 15, 2021

Last Updated

May 17, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

There is no need for a plan to make IPD available.