Accidental FallsNCT01933737
Kinesio Taping Effect on Postural Balance in Elderly
A study testing Kinesio Taping and 3M Micropore in people with Accidental Falls, run by University of Franca at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Kinesio Taping and 3M Micropore
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elderly, gender female
Who cannot join
- No severe orthopedic diseases
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Accidental Falls
- Being tested
- Kinesio Taping, 3M Micropore
- Keywords
- postural balance;, elderly;, proprioception;, prevention;, fall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingDevice
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 MicroporeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 3M Micropore |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2012
- Study completionJan 2013
Why it stopped: The collected data was finished
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Franca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Roberto Veiga Quemelo, University of Franca
- Investigators
- Paulo RV Quemelo, PhD, Principal investigator, University of Franca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933737
- Sponsor's protocol ID
- UNIFRAN
- Status last verified
- Aug 2013
- First submitted
- 21 Aug 2013
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22796389
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesio Taping Effect on Postural Balance in Elderly
- ClinicalTrials.gov ID
- NCT01933737
- Acronym / sponsor ID
- UNIFRAN
- Conditions
- Accidental Falls
- Keywords
- postural balance;, elderly;, proprioception;, prevention;, fall
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The collected data was finished
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of FrancaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping Group | Experimental | Device: Kinesio TapingThe 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. |
| Placebo tape group | Experimental | Device: 3M MicroporeThe 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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elderly, gender female
Key exclusion criteria (1 listed)
- No severe orthopedic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio TapingThe 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 Group |
| 3M MicroporeThe 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 | Placebo tape group |
Primary outcome
Force plate to postural balance
Time frame: 6 months
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
Results and safety
The study was stopped early (reason given: The collected data was finished). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2013.
- Results publication: PubMed 22796389Lins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo RV Quemelo, PhD principal investigator
University of Franca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping and 3M Micropore in people with Accidental Falls, run by University of Franca at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The collected data was finished). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Force plate to postural balance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01933737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2013.