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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
Banu BAYAR
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Acute stroke, Balance, Rehabilitation, Postural control

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 23, 2019
    Last Updated
    September 24, 2019
    Sponsor
    Banu BAYAR
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    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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