Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients
Primary Purpose
Stroke, Acute, Hemiplegia, Balance
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kinesio Taping
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute focused on measuring Acute stroke, Balance, Rehabilitation, Postural control
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Kinesio Taping on Abdominal Muscles
Kinesio Taping on Back Muscles
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04105322
Brief Title
Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients
Official Title
Early Effects of Trunk Kinesio Taping on Balance and Functional Performance in Patients With Acute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Banu BAYAR
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is planned to investigate the acute effects of trunk kinesio taping on balance and functional performance in acute stroke patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Hemiplegia, Balance, Functional Performance
Keywords
Acute stroke, Balance, Rehabilitation, Postural control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kinesio Taping on Abdominal Muscles
Arm Type
Experimental
Arm Title
Kinesio Taping on Back Muscles
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Kinesio Taping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Trunk Impairment Scale
Description
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.
Time Frame
Change of trunk impairment from baseline at the end of 48 hours of each kinesio taping intervention.
Title
Berg Balance Scale
Description
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.
Time Frame
Change of balance scores from baseline at the end of 48 hours of each kinesio taping intervention.
Title
Five Times Sit to Stand Test
Description
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.
Time Frame
Change of functional performance scores from baseline at the end of 48 hours of each kinesio taping intervention.
Secondary Outcome Measure Information:
Title
Wii Balance Board
Description
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.
Time Frame
Change of balance scores from baseline at the end of 48 hours of each kinesio taping intervention.
Title
Postural Assessment Scale for Stroke
Description
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.
Time Frame
Change of postural ability from baseline at the end of 48 hours of each kinesio taping intervention.
Title
Patient Satisfaction: Visual Analogue Scale (VAS)
Description
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.
Time Frame
Change of patient satisfaction at the end of 48 hours of each kinesio taping application.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asalet Aybüke GÜP, Bachelor
Phone
553 311 4049
Ext
+90
Email
asalet.a@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Banu BAYAR, Doctorate
Phone
252 211 3201
Ext
+90
Email
bbayar@mu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asalet Aybüke GÜP, Bachelor
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Banu BAYAR, Doctorate
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27630439
Citation
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.
Results Reference
background
PubMed Identifier
26409338
Citation
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.
Results Reference
background
PubMed Identifier
31003662
Citation
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.
Results Reference
background
PubMed Identifier
26321149
Citation
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.
Results Reference
background
PubMed Identifier
14758293
Citation
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.
Results Reference
background
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Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients
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