Older AdultNCT03487835
Role of Kinesiology Tape in Older Adults
A study testing Kinesiotape and No application in people with Older Adult, run by University of Yalova.
Trial summary
Aim: The present study aimed to investigate the role of Kinesiology ('Kinesio') tape in the physiological risk of falling in older adults. Methods: Twenty two older adults aged over 65 years and living in nursing homes. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adult
- What is being tested?
- Kinesiotape and No application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2016
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- After signing the consent form, individuals who agreed to participate underwent the Timed Up and Go test. Participants whose the Timed Up and Go (TUG) test score was over 13 s (Fig. 1),14) who showed full cooperation and who had no hearing or vision problems that would affect the ability to participate in the study evaluation methods were included in the study
Who cannot join
- Bedridden older adults, those with an acute disease or infection, those with cognitive problems [assessed by the Mini-Mental State Examination (MMSE)], a lower extremity orthosis or prosthesis, neurological issues and those who had endured a break in their lower extremities within the last 3 months were excluded from the study
About this study
Official title: Role of Kinesiology Tape in Reducing Physiological Fall Risk in Older Adults
Aim: The present study aimed to investigate the role of Kinesiology ('Kinesio') tape in the physiological risk of falling in older adults.
Methods: Twenty two older adults aged over 65 years and living in nursing homes. After assessment of demographic information, they were randomized into one of two groups [(Kinesio tape (n = 22) and control (n = 20)]. Kinesio tape was applied on the Kinesio tape group only and worn during a 2-week intervention period. Participants were evaluated with the Visual Analog Scale, Berg Balance Scale, Timed Up and Go Test, Mini-Mental State Examination, 30-Second Sit to Stand test and Functional Independent Measurement instrument at baseline, after 2 weeks of application and at 2-week follow-up.
Read the detailed description
Measures After participant demographics data (age, daily medication etc.) and their history of falls information been collected, the Berg Balance Scale (BBS), Functional Independence Measure (FIM), and Visual Analog Scale (VAS) were administered along with the Timed Up and Go test (TUG) and 30-Second Sit to Stand test (30s STS).
2.1. History of falls Participating adults were then asked about another resident's experience of falls in the preceding year. Interviews were conducted verbally.
2.2. The visual analog scale The VAS is a pain-intensity measurement scale that is both effective and simple to use; the reliability and validity of the VAS have been previously determined. To determine perceived body pain, individuals are asked to mark the intensity of their existing pain on a 10-cm scale where a range of numbers-from 0 (no pain) to 10 (unbearable pain)-are displayed to determine body pain (Tyler, Jensen, Engel and Schwartz, 2002).
2.3. The functional independence measure The FIM analyses two aspects of disability: motor and cognitive functions. The FIM is comprised of six functional categories: self-care, sphincter control, mobility, locomotion, communication, and social perception. A total of 18 activities are evaluated by the FIM to determine functional independence; a seven-point scale is used to evaluate each activity with the highest-possible score for the scale being 126 (Küçükdeveci, Yavuzer, Elhan, Sonel and Tennant, 2001).
2.4. The timed up and go The TUG test is an objective, reliable and simple measure aimed at evaluating balance and functional mobility; the TUG test can also be used to assess the risk of falling. Scores are calculated by measuring the number of seconds it takes for a participant to complete the test. The use of a walking aid is permitted during the test (Amold \& Faulkner, 2007).
2.5. 30-Second sit to stand The 30s STS test measures leg strength; the test records the number of times a patient can go from a sitting to a standing position within a 30-secondperiod. For the safety of the participant, the chair used for the test should be rested against a wall to ensure that it does not slip. The patient's transformation from a standing into a sitting position should be performed in full (Whitney et al., 2005).
2.5. The berg balance scale The BBS assesses balance by testing a patient's ability to maintain their balance while performing functional activities. The Berg Balance Scale is comprised of 14 items; each section is graded on a scale from 0 (bad) to 4 (best). Higher scores indicate better balance. Scores of 0-20 signify high risk, those of 21-40 signify medium risk and those of 41-64 signify low risk (Bogle \& Newton, 1996).
2.6. The mini-mental state examination The MMSE assesses an individuals' mental function. The standardization of this scale was established in Turkish by Güngen, Ertan, Eker, Yaşar, and Engin (2002); the scale is easily applicable and provides information regarding a participant's cognitive impairment. The highest possible score is 30, with higher scores indicating good cognitive status. Scores lower than 23-24 are generally suggestive of an 'abnormal' cognition; additional levels of score breakdown specified (Güngen, Ertan, Eker, Yaşar, Engin, 2002).
- 'Kinesio' tape application The original 'Kinesio' tape (5cm wide) for this study. Only those participants in the 'Kinesio' tape group only were taped; tape was applied in accordance with Kenzo Kase's 'Kinesio' taping manual (Kase et al., 1996; Kase et al., 2003). Before application of the tape, the area of application was wiped with water containing 70% alcohol; anything that might prevent the tape from adhering to patient's skin eliminated prior to the application. The length of the extremity subject to the tape's application was measured and three I-shaped tapes were cut accordingly; one tape was applied to the ankle and the other two tapes were applied along the base of the extremity to support the arches of the foot, starting around the malleoli (Figure 2 and 3).
Consequently, the patient's ankle and foot arches were supported; additionally, the researchers aimed to increase ankle stability and the proprioceptive sense the tape provided the foot and ankle. The application was performed by stretching the tape original length between 25-75%, according to the technique outlined by Kase, Wallis, and Kase (2003). An expert physiotherapist with a 'Kinesio' tape certificate applied the tape while the participant was in a sitting position, and was also responsible for taking all the appropriate measurements.. Individuals in the 'Kinesio' group were visited every other day for two-week intervention period. Tapes were verified during this period, and those with deformities were removed and new ones were applied instead. All participants had their tape removed and reapplied every three days. All participants lived in nursing homes and their nursing-home staff were informed about the study protocol. In particular, participants were informed that the tape did not need to be removed during bathing or situations such as getting dressed. After the two-week intervention period, the TUG, the BBS, 30s STS, FIM and VAS were re-administered to both the 'Kinesio' tape group and the control. During the two weeks that followed the second measurement, no 'Kinesio' tape application was conducted on either group. Two weeks following the end of the intervention period, a third set of measurements were taken from each group. In summary, three measurements were administered to each group, these included: one at baseline, prior to 'Kinesio' taping application; 1st measurement; one following application, 2nd measurement; and one after a two-week follow-up period, 3rd measurement. After study had been completed, the 'Kinesio' tape application was offered to individuals in the control group if they desired.
- Conditions
- Older Adult
- Being tested
- Kinesiotape, No application
- Keywords
- Athletic tape. Accidental Falls. Aging.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapeOther
No applicationOther
This group have no application during study time
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape group | Experimental | Not described Receives: Other: Kinesiotape |
| Control group | Experimental | Not described Receives: Other: No application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go Test and Berg Balance Scale
the application of 'Kinesio' tape has positive effects on functional mobility and balance in older adults
Measured: 4 days/ two weeks
the effect of time
The effects of 'Kinesio' tape last for at least two weeks after application
Measured: follow up two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study startDec 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Older AdultStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487835
- Sponsor's protocol ID
- 2015/298
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choi YK, Nam CW, Lee JH, Park YH. The Effects of Taping Prior to PNF Treatment on Lower Extremity Proprioception of Hemiplegic Patients. J Phys Ther Sci. 2013 Sep;25(9):1119-22. doi: 10.1589/jpts.25.1119. Epub 2013 Oct 20.
PubMed 24259927Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Med. 2012 Feb 1;42(2):153-64. doi: 10.2165/11594960-000000000-00000.
PubMed 22124445Yoshida A, Kahanov L. The effect of kinesio taping on lower trunk range of motions. Res Sports Med. 2007 Apr-Jun;15(2):103-12. doi: 10.1080/15438620701405206.
PubMed 17578750Hawk C, Hyland JK, Rupert R, Colonvega M, Hall S. Assessment of balance and risk for falls in a sample of community-dwelling adults aged 65 and older. Chiropr Osteopat. 2006 Jan 27;14:3. doi: 10.1186/1746-1340-14-3.
PubMed 16441893
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Kinesiology Tape in Reducing Physiological Fall Risk in Older Adults
- ClinicalTrials.gov ID
- NCT03487835
- Acronym / sponsor ID
- 2015/298
- Conditions
- Older Adult
- Keywords
- Athletic tape. Accidental Falls. Aging.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Apr 2018 (actual)
- 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.
Aim: The present study aimed to investigate the role of Kinesiology ('Kinesio') tape in the physiological risk of falling in older adults.
Methods: Twenty two older adults aged over 65 years and living in nursing homes. After assessment of demographic information, they were randomized into one of two groups [(Kinesio tape (n = 22) and control (n = 20)]. Kinesio tape was applied on the Kinesio tape group only and worn during a 2-week intervention period. Participants were evaluated with the Visual Analog Scale, Berg Balance Scale, Timed Up and Go Test, Mini-Mental State Examination, 30-Second Sit to Stand test and Functional Independent Measurement instrument at baseline, after 2 weeks of application and at 2-week follow-up.
Detailed description
Measures After participant demographics data (age, daily medication etc.) and their history of falls information been collected, the Berg Balance Scale (BBS), Functional Independence Measure (FIM), and Visual Analog Scale (VAS) were administered along with the Timed Up and Go test (TUG) and 30-Second Sit to Stand test (30s STS).
2.1. History of falls Participating adults were then asked about another resident's experience of falls in the preceding year. Interviews were conducted verbally.
2.2. The visual analog scale The VAS is a pain-intensity measurement scale that is both effective and simple to use; the reliability and validity of the VAS have been previously determined. To determine perceived body pain, individuals are asked to mark the intensity of their existing pain on a 10-cm scale where a range of numbers-from 0 (no pain) to 10 (unbearable pain)-are displayed to determine body pain (Tyler, Jensen, Engel and Schwartz, 2002).
2.3. The functional independence measure The FIM analyses two aspects of disability: motor and cognitive functions. The FIM is comprised of six functional categories: self-care, sphincter control, mobility, locomotion, communication, and social perception. A total of 18 activities are evaluated by the FIM to determine functional independence; a seven-point scale is used to evaluate each activity with the highest-possible score for the scale being 126 (Küçükdeveci, Yavuzer, Elhan, Sonel and Tennant, 2001).
2.4. The timed up and go The TUG test is an objective, reliable and simple measure aimed at evaluating balance and functional mobility; the TUG test can also be used to assess the risk of falling. Scores are calculated by measuring the number of seconds it takes for a participant to complete the test. The use of a walking aid is permitted during the test (Amold \& Faulkner, 2007).
2.5. 30-Second sit to stand The 30s STS test measures leg strength; the test records the number of times a patient can go from a sitting to a standing position within a 30-secondperiod. For the safety of the participant, the chair used for the test should be rested against a wall to ensure that it does not slip. The patient's transformation from a standing into a sitting position should be performed in full (Whitney et al., 2005).
2.5. The berg balance scale The BBS assesses balance by testing a patient's ability to maintain their balance while performing functional activities. The Berg Balance Scale is comprised of 14 items; each section is graded on a scale from 0 (bad) to 4 (best). Higher scores indicate better balance. Scores of 0-20 signify high risk, those of 21-40 signify medium risk and those of 41-64 signify low risk (Bogle \& Newton, 1996).
2.6. The mini-mental state examination The MMSE assesses an individuals' mental function. The standardization of this scale was established in Turkish by Güngen, Ertan, Eker, Yaşar, and Engin (2002); the scale is easily applicable and provides information regarding a participant's cognitive impairment. The highest possible score is 30, with higher scores indicating good cognitive status. Scores lower than 23-24 are generally suggestive of an 'abnormal' cognition; additional levels of score breakdown specified (Güngen, Ertan, Eker, Yaşar, Engin, 2002).
- 'Kinesio' tape application The original 'Kinesio' tape (5cm wide) for this study. Only those participants in the 'Kinesio' tape group only were taped; tape was applied in accordance with Kenzo Kase's 'Kinesio' taping manual (Kase et al., 1996; Kase et al., 2003). Before application of the tape, the area of application was wiped with water containing 70% alcohol; anything that might prevent the tape from adhering to patient's skin eliminated prior to the application. The length of the extremity subject to the tape's application was measured and three I-shaped tapes were cut accordingly; one tape was applied to the ankle and the other two tapes were applied along the base of the extremity to support the arches of the foot, starting around the malleoli (Figure 2 and 3).
Consequently, the patient's ankle and foot arches were supported; additionally, the researchers aimed to increase ankle stability and the proprioceptive sense the tape provided the foot and ankle. The application was performed by stretching the tape original length between 25-75%, according to the technique outlined by Kase, Wallis, and Kase (2003). An expert physiotherapist with a 'Kinesio' tape certificate applied the tape while the participant was in a sitting position, and was also responsible for taking all the appropriate measurements.. Individuals in the 'Kinesio' group were visited every other day for two-week intervention period. Tapes were verified during this period, and those with deformities were removed and new ones were applied instead. All participants had their tape removed and reapplied every three days. All participants lived in nursing homes and their nursing-home staff were informed about the study protocol. In particular, participants were informed that the tape did not need to be removed during bathing or situations such as getting dressed. After the two-week intervention period, the TUG, the BBS, 30s STS, FIM and VAS were re-administered to both the 'Kinesio' tape group and the control. During the two weeks that followed the second measurement, no 'Kinesio' tape application was conducted on either group. Two weeks following the end of the intervention period, a third set of measurements were taken from each group. In summary, three measurements were administered to each group, these included: one at baseline, prior to 'Kinesio' taping application; 1st measurement; one following application, 2nd measurement; and one after a two-week follow-up period, 3rd measurement. After study had been completed, the 'Kinesio' tape application was offered to individuals in the control group if they desired.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape group | Experimental | Other: Kinesiotape |
| Control group | Experimental | Other: No application |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- After signing the consent form, individuals who agreed to participate underwent the Timed Up and Go test. Participants whose the Timed Up and Go (TUG) test score was over 13 s (Fig. 1),14) who showed full cooperation and who had no hearing or vision problems that would affect the ability to participate in the study evaluation methods were included in the study
Key exclusion criteria (1 listed)
- Bedridden older adults, those with an acute disease or infection, those with cognitive problems [assessed by the Mini-Mental State Examination (MMSE)], a lower extremity orthosis or prosthesis, neurological issues and those who had endured a break in their lower extremities within the last 3 months were excluded from the study
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 |
|---|---|---|
| Kinesiotape | Other | Kinesiotape group |
| No applicationThis group have no application during study time | Other | Control group |
Primary outcome
Timed Up and Go Test and Berg Balance Scale
Time frame: 4 days/ two weeks
the application of 'Kinesio' tape has positive effects on functional mobility and balance in older adults
the effect of time
Time frame: follow up two weeks
The effects of 'Kinesio' tape last for at least two weeks after application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Background: PubMed 24259927Choi YK, Nam CW, Lee JH, Park YH. The Effects of Taping Prior to PNF Treatment on Lower Extremity Proprioception of Hemiplegic Patients. J Phys Ther Sci. 2013 Sep;25(9):1119-22. doi: 10.1589/jpts.25.1119. Epub 2013 Oct 20.
- Background: PubMed 22124445Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Med. 2012 Feb 1;42(2):153-64. doi: 10.2165/11594960-000000000-00000.
- Background: PubMed 17578750Yoshida A, Kahanov L. The effect of kinesio taping on lower trunk range of motions. Res Sports Med. 2007 Apr-Jun;15(2):103-12. doi: 10.1080/15438620701405206.
- Results publication: PubMed 16441893Hawk C, Hyland JK, Rupert R, Colonvega M, Hall S. Assessment of balance and risk for falls in a sample of community-dwelling adults aged 65 and older. Chiropr Osteopat. 2006 Jan 27;14:3. doi: 10.1186/1746-1340-14-3.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotape and No application in people with Older Adult, run by University of Yalova.
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: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Timed Up and Go Test and Berg Balance Scale (time frame: 4 days/ two weeks). The study lists 2 primary outcomes in all. 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 NCT03487835, which also lists 4 linked publications.
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 4 Apr 2018.