NCT02115217

Brief Summary

Ankles sprains are the most popular injuries in basketball players. They are traumatic injuries, which happen most of the time in specific situations, like landing on another player's foot, or during changes of direction. Neuromuscular exercises are very important to improve ankle stability and reduce risks of sprains. However various external support such as ankles braces and rigid tape, are also used in order to prevent injury. The kinesiotape (KT) is a new but broadly used method in the world of athletes. Created by KenzoKase, in 1980, this kind of tape has a tremendous success with athletes and is today commonly used during practices and/or competitions. The main property of this tape is its elasticity, which is supposed to improve proprioception and, thus ankle stability, but these aspects have not been investigated yet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

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

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 31, 2019

Status Verified

July 1, 2015

Enrollment Period

9 months

First QC Date

March 14, 2014

Last Update Submit

January 29, 2019

Conditions

Sprain and Strain of Ankle

Keywords

KinestiotapingBasketball playersEffect of kinesiotapingon postural stability

Outcome Measures

Primary Outcomes (1)

  • Effect of kinesiotaping on postural stability

    To assess postural stability, the following parameters will be measured: Autonomy: This measure represents the time the subject can stay on the mobile board without the use of his hand to maintain equilibrium. Mean axis spacing: This measure will be performed using an accelerometer localized on the sternum of the subjects. This device will allow us to calculate displacement of the chest (degrees of inclination). Mean error of the board: This parameter represents numerically the inclination of the board during the test. It allows to estimate the stability of the subjects' ankle (unit=degrees). The larger this value is the lower the stability will be. An estimation of total equilibrium between each subject will be assessed using the two parameters listed here above (mean axis spacing + mean error of the board) following recommendation of the manufacturer.

    For each subject outcome will be assessed in the 3 weeks following the beginning of the study.

Secondary Outcomes (1)

  • EVA scale to evaluate the sensation of postural stability

    Assessment will be performed within 3 weeks after the beginning of the study

Study Arms (2)

Leukotape K, basketball training

EXPERIMENTAL

Use of Leukotape K to ensure stability of the ankle in basketball players

Device: Leukotape K

Sham, basketball training

PLACEBO COMPARATOR

Use of sham tape

Device: Sham kinesiotape

Interventions

Leukotape KDEVICE

All interventions will be performed by a qualified physiotherapist in a standardized manner. Tape will be extended to the recommended length (120%) and applied along the outer side of the leg, along the path of the peroneal muscle. Starting in the middle of the foot arch, the tape ends 1 cm below tibial head.

Also known as: Leukotape K, Johnson & Johnson
Leukotape K, basketball training
Sham kinesiotapeDEVICE

KT put with no effects

Sham, basketball training

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • active elite basketball players

You may not qualify if:

  • no history of ankle sprain in the last 6 weeks
  • no history of any other lower limbs lesion in the last 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Romande de Réadaptation

Sion, Valais, 1951, Switzerland

Location

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Yan Eggel, MD

    Clinique Romande de Readaptation

    PRINCIPAL INVESTIGATOR

  • Lia Volpe, Student

    Institut des Sciences du Sport de l'Université de Lausanne

    PRINCIPAL INVESTIGATOR

  • Olivier Dériaz, Md, PhD

    Institut de Recherche en Readaptation

    STUDY DIRECTOR

  • Jérôme Barral, PhD

    Institut des Sciences du Sport de l'Université de Lausanne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

April 15, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2014

Study Completion

June 1, 2015

Last Updated

January 31, 2019

Record last verified: 2015-07

Locations

CH(1)