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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01933737
Other study ID # UNIFRAN
Secondary ID
Status Terminated
Phase N/A
First received August 21, 2013
Last updated August 30, 2013
Start date January 2012
Est. completion date January 2013

Study information

Verified date August 2013
Source University of Franca
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

The Kinesio Taping Group (KTG) was composed of 31 participants that received the application of KT (K-Taping®) on the gastrocnemius muscle and the muscles of the midfoot. The placebo tape group (PTG) was composed of 31 participants that received the application of a placebo tape (3M Micropore®) on the same muscles of both limbs. The order of application of KT tape and placebo was conducted randomly among the elderly. Before the tape applying the site was cleaned with 70% ethanol for better fixation of the tape and for both groups were determined the application technique in "I" shaped. This technique consist in placing two tapes that format. The first tape was placed along the length of the plantar aponeurosis fixed point in the middle third of the medial gastrocnemius muscle to the metatarsal phalangeal joint. The second tape was also applied in "I" shaped without fixed point was placed around the midfoot arch in the direction of tension lines to assist with the metatarsal arch support.


Recruitment information / eligibility

Status Terminated
Enrollment 61
Est. completion date January 2013
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years to 75 Years
Eligibility Inclusion Criteria:

- elderly, gender female

Exclusion Criteria:

- No severe orthopedic diseases

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Kinesio Taping
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.
3M Micropore
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.

Locations

Country Name City State
Brazil University of Franca Franca Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Franca

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Lins CA, Neto FL, Amorim AB, Macedo Lde B, Brasileiro JS. Kinesio Taping(®) 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): — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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