- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04105322
Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients
September 24, 2019 updated by: Banu BAYAR
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control
|
|
|
EXPERIMENTAL: Kinesio Taping on Abdominal Muscles
|
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.
|
|
EXPERIMENTAL: Kinesio Taping on Back Muscles
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change of trunk impairment from baseline at the end of 48 hours of each kinesio taping intervention.
|
|
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.
|
Change of balance scores from baseline at the end of 48 hours of each kinesio taping intervention.
|
|
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. |
Change of functional performance scores from baseline at the end of 48 hours of each kinesio taping intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wii Balance Board
Time Frame: Change of balance scores from baseline at the end of 48 hours of each kinesio taping intervention.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Change of patient satisfaction at the end of 48 hours of each kinesio taping application.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Asalet Aybüke GÜP, Bachelor, Muğla Sıtkı Koçman University
- Study Director: Banu BAYAR, Doctorate, Muğla Sıtkı Koçman University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Yazici 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.
- Wang 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.
- Rojhani-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.
- Karatas 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2019
Primary Completion (ANTICIPATED)
March 1, 2020
Study Completion (ANTICIPATED)
May 1, 2020
Study Registration Dates
First Submitted
September 23, 2019
First Submitted That Met QC Criteria
September 24, 2019
First Posted (ACTUAL)
September 26, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 26, 2019
Last Update Submitted That Met QC Criteria
September 24, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190135/133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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