Stroke, AcuteNCT04105322
Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients
A study testing Kinesio Taping in people with Stroke, Acute and Hemiplegia, run by Banu BAYAR.
Trial summary
This study is planned to investigate the acute effects of trunk kinesio taping on balance and functional performance in acute stroke patients. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Stroke, Acute, Hemiplegia, Balance
- What is being tested?
- Kinesio Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to May 2020
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30-85 years
- Duration onset of stroke < 1 month Stroke time is between 0-1 months
- Score of Modified Rankin Scale 0-3
- Score of Mini Mental Test ≥ 24
Who cannot join
- Not volunteering to participate in the study
- Having another stroke history
- Having a history of fracture or surgical operation involving the lower extremity
- Have another neurological or orthopedic disorder affecting functionality
- Having visual or hearing problems
- Presence of skin lesions (decubitus ulcer, active infection, burns, malignancy, cellulite, scar, etc.) at the site of application.
- Allergic reaction to kinesio tape
- Being obese
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Early Effects of Trunk Kinesio Taping on Balance and Functional Performance in Patients With Acute Stroke
This study is planned to investigate the acute effects of trunk kinesio taping on balance and functional performance in acute stroke patients.
- Conditions
- Stroke, Acute, Hemiplegia, Balance, Functional Performance
- Being tested
- Kinesio Taping
- Keywords
- Acute stroke, Balance, Rehabilitation, Postural control
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingOther
The kinesio tape is adhesive and it does not contain drug substance. After the patients were randomized to the groups, kinesio tape will be applied to the relevant region.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping on Abdominal Muscles | Experimental | Not described Receives: Other: Kinesio Taping |
| Kinesio Taping on Back Muscles | Experimental | Not described Receives: Other: Kinesio Taping |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Impairment Scale
This scale comprises 17 items and evaluates static and dynamic sitting balance and trunk coordination. The items of the scale are scored on a 2-, 3- or 4-point ordinal scale. The total score ranges from a minimum of 0 to a maximum 23 points, higher scores indicate better performance.
Measured: Change of trunk impairment from baseline at the end of 48 hours of each kinesio taping intervention.
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Measured: Change of balance scores from baseline at the end of 48 hours of each kinesio taping intervention.
Five Times Sit to Stand Test
This test reproduces the act of sitting and standing for five repetitions as rapidly as possible.
The test performance was based on its duration; consequently, the shorter time taken by the patient, the better their functional condition would be.
Measured: Change of functional performance scores from baseline at the end of 48 hours of each kinesio taping intervention.
Secondary outcomes (3)
Wii Balance Board
The Basic Balance Test game will be used to assess the person's balance. At the end of this game is the routine evaluation of the device Wii Fit age; The patient's demographic characteristics, body mass index, weight transferred to the right and left foot and the Basic Balance Test will be calculated by the device using the game result. The fact that the resulting age is greater than the actual age of the patient will be considered as an inability to balance.
Measured: Change of balance scores from baseline at the end of 48 hours of each kinesio taping intervention.
Postural Assessment Scale for Stroke
This scale contains 12 items for evaluating balance: 5 items to assess the maintenance of posture and 7 items to evaluate changes in posture. Each Postural Assessment Scale for Stroke item is rated on a scale from 0 to 3, for a maximum total score of 36: on this scale, the higher the score is, the more favourable the balance in stroke patients.
Measured: Change of postural ability from baseline at the end of 48 hours of each kinesio taping intervention.
Patient Satisfaction: Visual Analogue Scale (VAS)
It will be evaluated with the Visual Analogue Scale (VAS). The VAS consists of a 10 cm horizontal line. The left end of the line has the number 0 and the right end has the number 10. Number 0 means mad I'm not satisfied at all ken, while number 10 is considered "very satisfied". Satisfaction level increases from left to right on the line.
Measured: Change of patient satisfaction at the end of 48 hours of each kinesio taping application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banu BAYAR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Banu BAYAR, Muğla Sıtkı Koçman University
- Investigators
- Asalet Aybüke GÜP, Bachelor, Principal investigator, Muğla Sıtkı Koçman UniversityBanu BAYAR, Doctorate, Study director, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105322
- Sponsor's protocol ID
- 190135/133
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee YJ, Kim JY, Kim SY, Kim KH. The effects of trunk kinesio taping on balance ability and gait function in stroke patients. J Phys Ther Sci. 2016 Aug;28(8):2385-8. doi: 10.1589/jpts.28.2385. Epub 2016 Aug 31.
PubMed 27630439Yazici G, Guclu-Gunduz A, Bayraktar D, Aksoy S, Nazliel B, Kilinc M, Yildirim SA, Irkec C. Does correcting position and increasing sensorial input of the foot and ankle with Kinesio Taping improve balance in stroke patients? NeuroRehabilitation. 2015;36(3):345-53. doi: 10.3233/NRE-151223.
PubMed 26409338Wang M, Pei ZW, Xiong BD, Meng XM, Chen XL, Liao WJ. Use of Kinesio taping in lower-extremity rehabilitation of post-stroke patients: A systematic review and meta-analysis. Complement Ther Clin Pract. 2019 May;35:22-32. doi: 10.1016/j.ctcp.2019.01.008. Epub 2019 Jan 17.
PubMed 31003662Rojhani-Shirazi Z, Amirian S, Meftahi N. Effects of Ankle Kinesio Taping on Postural Control in Stroke Patients. J Stroke Cerebrovasc Dis. 2015 Nov;24(11):2565-71. doi: 10.1016/j.jstrokecerebrovasdis.2015.07.008. Epub 2015 Aug 29.
PubMed 26321149Karatas M, Cetin N, Bayramoglu M, Dilek A. Trunk muscle strength in relation to balance and functional disability in unihemispheric stroke patients. Am J Phys Med Rehabil. 2004 Feb;83(2):81-7. doi: 10.1097/01.PHM.0000107486.99756.C7.
PubMed 14758293
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Effects of Trunk Kinesio Taping on Balance and Functional Performance in Patients With Acute Stroke
- ClinicalTrials.gov ID
- NCT04105322
- Acronym / sponsor ID
- 190135/133
- Conditions
- Stroke, Acute, Hemiplegia, Balance, Functional Performance
- Keywords
- Acute stroke, Balance, Rehabilitation, Postural control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Banu BAYARUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 26 Sep 2019 (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.
This study is planned to investigate the acute effects of trunk kinesio taping on balance and functional performance in acute stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping on Abdominal Muscles | Experimental | Other: Kinesio Taping |
| Kinesio Taping on Back Muscles | Experimental | Other: Kinesio Taping |
| Control | No intervention | – |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 30-85 years
- Duration onset of stroke < 1 month Stroke time is between 0-1 months
- Score of Modified Rankin Scale 0-3
- Score of Mini Mental Test ≥ 24
Key exclusion criteria (8 listed)
- Not volunteering to participate in the study
- Having another stroke history
- Having a history of fracture or surgical operation involving the lower extremity
- Have another neurological or orthopedic disorder affecting functionality
- Having visual or hearing problems
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 tape is adhesive and it does not contain drug substance. After the patients were randomized to the groups, kinesio tape will be applied to the relevant region. | Other | Kinesio Taping on Abdominal Muscles, Kinesio Taping on Back Muscles |
Primary outcome
Trunk Impairment Scale
Time frame: Change of trunk impairment from baseline at the end of 48 hours of each kinesio taping intervention.
This scale comprises 17 items and evaluates static and dynamic sitting balance and trunk coordination. The items of the scale are scored on a 2-, 3- or 4-point ordinal scale. The total score ranges from a minimum of 0 to a maximum 23 points, higher scores indicate better performance.
Berg Balance Scale
Time frame: Change of balance scores from baseline at the end of 48 hours of each kinesio taping intervention.
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Five Times Sit to Stand Test
Time frame: Change of functional performance scores from baseline at the end of 48 hours of each kinesio taping intervention.
This test reproduces the act of sitting and standing for five repetitions as rapidly as possible. The test performance was based on its duration; consequently, the shorter time taken by the patient, the better their functional condition would be.
3 secondary outcomes
Wii Balance Board
Time frame: Change of balance scores from baseline at the end of 48 hours of each kinesio taping intervention.
Postural Assessment Scale for Stroke
Time frame: Change of postural ability from baseline at the end of 48 hours of each kinesio taping intervention.
Patient Satisfaction: Visual Analogue Scale (VAS)
Time frame: Change of patient satisfaction at the end of 48 hours of each kinesio taping application.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 27630439Lee YJ, Kim JY, Kim SY, Kim KH. The effects of trunk kinesio taping on balance ability and gait function in stroke patients. J Phys Ther Sci. 2016 Aug;28(8):2385-8. doi: 10.1589/jpts.28.2385. Epub 2016 Aug 31.
- Background: PubMed 26409338Yazici G, Guclu-Gunduz A, Bayraktar D, Aksoy S, Nazliel B, Kilinc M, Yildirim SA, Irkec C. Does correcting position and increasing sensorial input of the foot and ankle with Kinesio Taping improve balance in stroke patients? NeuroRehabilitation. 2015;36(3):345-53. doi: 10.3233/NRE-151223.
- Background: PubMed 31003662Wang M, Pei ZW, Xiong BD, Meng XM, Chen XL, Liao WJ. Use of Kinesio taping in lower-extremity rehabilitation of post-stroke patients: A systematic review and meta-analysis. Complement Ther Clin Pract. 2019 May;35:22-32. doi: 10.1016/j.ctcp.2019.01.008. Epub 2019 Jan 17.
- Background: PubMed 26321149Rojhani-Shirazi Z, Amirian S, Meftahi N. Effects of Ankle Kinesio Taping on Postural Control in Stroke Patients. J Stroke Cerebrovasc Dis. 2015 Nov;24(11):2565-71. doi: 10.1016/j.jstrokecerebrovasdis.2015.07.008. Epub 2015 Aug 29.
- Background: PubMed 14758293Karatas M, Cetin N, Bayramoglu M, Dilek A. Trunk muscle strength in relation to balance and functional disability in unihemispheric stroke patients. Am J Phys Med Rehabil. 2004 Feb;83(2):81-7. doi: 10.1097/01.PHM.0000107486.99756.C7.
- Individual participant dataSharing planned: No
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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.
Asalet Aybüke GÜP, Bachelor principal investigator
Muğla Sıtkı Koçman University
Banu BAYAR, Doctorate study director
Muğla Sıtkı Koçman University
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping in people with Stroke, Acute and Hemiplegia, run by Banu BAYAR.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asalet Aybüke GÜP, Bachelor (553 311 4049 ext. +90, asalet.a@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Impairment Scale (time frame: Change of trunk impairment from baseline at the end of 48 hours of each kinesio taping intervention.). The study lists 3 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 NCT04105322, which also lists 5 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 26 Sep 2019.