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

NCT ID: NCT03219905

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Kinesio-taping Group

Therapeutic Kinesio-taping

Group Type: EXPERIMENTAL

Therapeutic Kinesio-taping

Intervention Type: DEVICE

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.

Control Group

Sham Kinesio-taping

Group Type: SHAM_COMPARATOR

Sham Kinesio-taping

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

Haydar Gok

Professor of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haydar Gok, Professor

Role: PRINCIPAL_INVESTIGATOR

Ankara University

References

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Other Identifiers

05-213-14

Identifier Type: -

Identifier Source: org_study_id