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Does "Kinesio-taping" Affect Balance in Healthy Individuals?

14 июля 2017 г. обновлено: Haydar Gok, Ankara University

Does "Kinesio-taping" Affect Standing Balance in Healthy Individuals? A Randomized Controlled Pilot Trial

Kinesio-taping (KT) has recently gained so much popularity and a growing number of physicians started using it to alleviate musculoskeletal symptoms. It was originally developed by Kenzo Kase in 1976. The effects of KT on ankle proprioception and stability have been investigated in previous studies. However, these studies are limited and the current data is conflicting. Repeated application of KT in a patient with chronic ankle instability has been shown to be effective in improving balance. In basketball players with chronic ankle sprain, KT did not improve or inhibit balance. Application of KT did not cause a significant change in balance of healthy subjects. The aim of this study was to evaluate the immediate and short-term effects of KT on balance of healthy subjects.

Обзор исследования

Статус

Завершенный

Подробное описание

Thirty male healthy volunteers (between 18-40 ages) were screened for eligibility by physical examination and history. Informed written consent was obtained from all participants before enrollment. The research proposal was reviewed and approved by the Faculty Ethics Committee(No: 05-213-14).

This is a randomized sham controlled, double-blind pilot clinical trial. The block randomization method with a block size of 4 was used in order to allocate the subjects equally into two groups; Kinesiotaping (KT) and sham (control).To conceal the randomization sequence an independent researcher (HG) who is unaware of the baseline data carried out the procedure using a computer software. The researcher (MO) who was blinded to the allocationprocedure did the balance testing of all subjects, before (t0), immediately after (t1) and 24 hours after the application of KT (T2). The subjects were also blinded to the type of intervention.

Standard 2-inch (5-cm) Kinesio® Tex (Kinesio Holding Corporation, Albuquerque, NM) Tape was used for all applications in both groups. A certified KT practitioner (BST) did the all taping procedures. KT was applied bilaterally to the ankle joints. To ensure blinding of the assessor (MÖ), taping procedure was done in a separate room and subjects wore their socks after the application. The tape remained in place for 24 hours duration and subjects were instructed to participate in their normal daily activities, except shower.

The experimental group received a standardized therapeutic Kinesio Tape application. Three "I" strips were applied to the both ankle joints for joint stability with subject's ankle at 90 degrees. KT was applied according to the procedures recommended by the website of http://www.kttapeeurope.com/How-to-tape-Ankle-Stability (last accessed on July 7th, 2017). First strip was anchored 5 cm above the ankle. Then tape was applied down the outer ankle, across the bottom of the heel, and up the inner side of the ankle. The last 5cm of tape was laid without stretch. Second strip was anchored along the instep of the foot. Then tape was laid around the back of the heel and across the arch with 50% stretch. The last part of tape was laid down without stretch on inside of foot. Third strip was anchored same style along the outside of the foot. The tape was laid the around the back of the heel and across the arch with 50% stretch. The last 5 cm of the tape was laid down without stretch on insideof foot. The control group received a sham Kinesio Tape application. Ankle position was hold at minimally plantar flexion during taping. A"I" strip was placed from the anterior midfoot, not stretched and attached to the midline of anterior leg.

Each participant's height and weight were recorded and body mass index (BMI) was calculated. Balance measurements were made with a stabilometer, BiodexTM Balance System. A dynamic postural stability test was performed in a double-leg standing position with eyes open. Each test included three trials that lasted 20 seconds with a 10-second rest period between them. A mean score was calculated from three trials. Subjects were given a practice trial lasting 20 sec. to familiarize with the test. During the dynamic postural stability test three indices were calculated; (1) anteroposterior stability index (APSI), (2) mediolateral stability index (MLSI), (3) overall stability index (OSI). The OSI indicates the total variation in plate deviation (sway) from the horizontal plane. The APSI and MLSI indicate the deviation of the plate (sway) from the horizontal position in the sagittal and frontal planes, respectively. Since the values obtained during measurements indicate the amount of sway from the horizontal position, lower scores show better balance.

Non-parametric tests have been used due to the small sample size and skewed data distribution. The baseline demographic characteristics of the patients in each group were compared by Mann Whitney U test. The two-way mixed ANOVA was used to compare the mean differences between independent groups over time and to understand if there is an interaction between time and group factors.

Тип исследования

Интервенционный

Регистрация (Действительный)

24

Фаза

  • Непригодный

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 40 лет (Взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Мужской

Описание

Inclusion Criteria:

  • Healthy male volunteers
  • Age between 18-40 years
  • polyneuropathy or neurological deficits

Exclusion Criteria:

Individuals with;

  • lower extremity fractures
  • knee or ankle ligamentous injury
  • conditions affecting balance, knee, hip or spinal osteoarthritis
  • lower extremity or back surgery
  • polyneuropathy or neurological deficits

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Kinesio-taping Group
Therapeutic Kinesio-taping
The experimental group received a therapeutic Kinesio Tape application. Three "I" strips were applied to the both ankle joints for joint stability with subject's ankle at 90 degrees.
Фальшивый компаратор: Control Group
Sham Kinesio-taping
The control group received a sham Kinesio Tape application. Ankle position was hold at minimally plantar flexion during taping. A"I" strip was placed from the anterior midfoot, not stretched and attached to the midline of anterior leg.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mediolateral stability index (MLSI)
Временное ограничение: Change from Baseline in MLSI immediately after KT application
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Change from Baseline in MLSI immediately after KT application
Mediolateral stability index (MLSI)
Временное ограничение: Change from Baseline in MLSI 24 hours after KT application
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Change from Baseline in MLSI 24 hours after KT application

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Anteroposterior stability index (APSI)
Временное ограничение: Change from Baseline in APSI immediately after KT application
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Change from Baseline in APSI immediately after KT application
Anteroposterior stability index (APSI)
Временное ограничение: Change from Baseline in APSI 24 hours after KT application
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Change from Baseline in APSI 24 hours after KT application
Overall stability index (OSI)
Временное ограничение: Change from Baseline in OSI immediately after KT application
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Change from Baseline in OSI immediately after KT application
Overall stability index (OSI)
Временное ограничение: Change from Baseline in OSI 24 hours after KT application
A dynamic postural stability test which is performed in a double-leg standing position with eyes open.
Change from Baseline in OSI 24 hours after KT application

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 апреля 2014 г.

Первичное завершение (Действительный)

1 июня 2014 г.

Завершение исследования (Действительный)

1 июня 2014 г.

Даты регистрации исследования

Первый отправленный

14 июля 2017 г.

Впервые представлено, что соответствует критериям контроля качества

14 июля 2017 г.

Первый опубликованный (Действительный)

18 июля 2017 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

18 июля 2017 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

14 июля 2017 г.

Последняя проверка

1 июля 2017 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • 05-213-14

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Therapeutic Kinesio-taping

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