NCT01933737

Brief Summary

The elderly population has increased significantly in the last years. The number of falls has also increased due to the decrease of balance. The Kinesio Taping (KT) is a method with the aim to improve muscle physiology, proprioception, coordination and balance. The aim of the study was to investigate the effect of KT on postural balance in the elderly. We evaluated 62 elderly with a mean age of 67.98±5.321, female, submitted to the protocol for the application of KT in gastrocnemius muscles of the midfoot and a placebo tape (3M Micropore) in the control group. The application of the tapes was bilateral. Half of the participants (n=31) received KT in the lower limbs, while the control group (n=31) was applied placebo tape. To analysis of posture and balance, we used a force plate to record stabilometric signals. Both groups were evaluated post-application and 48 hours after application of the tape. The variables used were total displacement in centimeters (cm), amplitude AP (anterior-posterior) and ML (medial-lateral) in centimeters, area (cm²) and speed AP and ML in centimeters for seconds. The experimental protocol was performed in standing posture and the subjects were instructed to stand with feet apart, eyes open to look at the fixed point 1.5 m from force plate in a horizontal direction. It was requested that the elderly maintain the position for a time of 40 seconds to collect data The data were collected immediately post application of tapes and after 48 hours. The data was tabulated, descriptive statistics were calculated. Statistical analysis was performed using the GraphPad Prism 4.0 software (Prism, Chicago, IL). The Kolmogorov Smirnov test was used to verify the data distribution. Differences between the means were evaluated using the Student T test for the normally distributed data, and using the Mann-Whitney test for the data not normally distributed. Significance levels were set at p\<0.05.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
Last Updated

September 2, 2013

Status Verified

August 1, 2013

Enrollment Period

Same day

First QC Date

August 21, 2013

Last Update Submit

August 30, 2013

Conditions

Keywords

postural balance;elderly;proprioception;prevention;fall

Outcome Measures

Primary Outcomes (1)

  • Force plate to postural balance

    To analysis of posture and balance, we used a force plate to record stabilometric signals. Both groups were evaluated post-application and 48 hours after application of the tape. The variables used were total displacement in centimeters (cm), amplitude AP (anterior-posterior) and ML (medial-lateral) in centimeters, area (cm²) and speed AP and ML in centimeters for seconds. We did not observe adverse effects

    6 months

Study Arms (2)

Kinesio Taping Group

EXPERIMENTAL

The Kinesio Taping group (KTG) (n = 31 elderly women) were submitted to the protocol of applying Kinesio Taping for gastrocnemius muscle and the muscles of the median foot. The application of the tapes was bilateral limbs. The subjects were evaluated post-application and 48 hours after application of the tape.

Device: Kinesio Taping

Placebo tape group

EXPERIMENTAL

The placebo tape group (PTG) (n = 31 elderly women) were submitted to the protocol of applying placebo tape (3M Micropore) for gastrocnemius muscle and the muscles of the median foot in the same way that KTG. The application of the tapes was bilateral limbs. The subjects were evaluated post-application and 48 hours after application of the tape.

Device: 3M Micropore

Interventions

The Kinesio Taping group (KTG) (n = 31 elderly women) were submitted to the protocol of applying Kinesio Taping for gastrocnemius muscle and the muscles of the median foot. The application of the tapes was bilateral limbs. The subjects were evaluated post-application and 48 hours after application of the tape.

Kinesio Taping Group

The placebo tape group (PTG) (n = 31 elderly women) were submitted to the protocol of applying placebo tape (3M Micropore) for gastrocnemius muscle and the muscles of the median foot in the same way that KTG. The application of the tapes was bilateral limbs. The subjects were evaluated post-application and 48 hours after application of the tape.

Placebo tape group

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elderly, gender female

You may not qualify if:

  • No severe orthopedic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Franca

Franca, São Paulo, 14404600, Brazil

Location

Related Publications (1)

  • Lins CA, Neto FL, Amorim AB, Macedo Lde B, Brasileiro JS. Kinesio Taping((R)) does not alter neuromuscular performance of femoral quadriceps or lower limb function in healthy subjects: randomized, blind, controlled, clinical trial. Man Ther. 2013 Feb;18(1):41-5. doi: 10.1016/j.math.2012.06.009. Epub 2012 Jul 15.

Study Officials

  • Paulo RV Quemelo, PhD

    University of Franca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Paulo Quemelo

Study Record Dates

First Submitted

August 21, 2013

First Posted

September 2, 2013

Study Start

January 1, 2012

Primary Completion

January 1, 2012

Study Completion

January 1, 2013

Last Updated

September 2, 2013

Record last verified: 2013-08

Locations