search
Back to results

Effectiveness of Kinesio Taping On Balance In Patients With Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Athletic Tape, Proprioception, Hemiplegia, Gait

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Willing to participate
  • Diagnosed with Stroke
  • Mini-Mental State Test score equal or above 25
  • Modified Ashworth Scale Score lover then 3
  • Able to walk 10 meter independently

Exclusion Criteria:

  • Secondary neurological diseases
  • Cognitive problems

Sites / Locations

  • Abant Izzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

Taping will be applied three times and will be reapplied one and two weeks later prior to first application for two weeks.

Control group would not receive any taping in order to prevent sham taping sensory stimulation effect.

Outcomes

Primary Outcome Measures

Balance evaluation systems test (BESTest)-Change from Baseline
BESTest contains 27 question under 6 subsections (biomechanical, stability limits, postural responses, anticipatory postural adjustments, sensory orientation, and dynamic balance during gait) all of which rates between 0 (unable) - 3 (normal function) points (22) was used to assess the dynamic and static balance during the activities. TUG was used to assess balance, mobility and walking ability of the patients before and after the procedure as a part of the BESTest. However, as a strong indicator of functional mobility we decided to analyze TUG results separately from the overall BESTest outcomes. Assessments will be conducted at baseline, after first application,one week later and 2 weeks later prior to first assessment.

Secondary Outcome Measures

Functional reach test (FRT)-Change from Baseline
FRT was used to assess the limits of stability by measuring the distance that a patient can reach forward without losing balance. The test was performed while patient standing on both feet next to a wall. A measurement tape fixed to the wall on the level of patients' acromion. Cut of score was taken as 25 cm. Assessments will be conducted at baseline, after first application,one week later and 2 weeks later prior to first assessment.
Tetrax balance systems-Change from Baseline
Tetrax balance system which focuses measuring static balance and postural sways with integrated 4 force plates for tracking weight difference on forefoot and hindfoot. Primary principal of this device is to measure the center of mass and postural sways by using 4 force plates. Assessment was performed while patients standing on the force plates eyes facing forward and without touching anything with their hands. Normal values were taken as 1.0 standard deviation below and 1.5 standard deviation above the mean scores. Higher result related to somato-sensory dysfunction. For weight distribution index it is expected to %25 of total body weight recorded on each plate. Assessments will be conducted at baseline, after first application,one week later and 2 weeks later prior to first assessment.
Functional Independence Measure (FIM)-Change from Baseline
Index for measuring both motor and cognitive independency level of patients under total 18 questions. Scores vary from completely independent to completely dependent. Assessments will be conducted at baseline, after first application,one week later and 2 weeks later prior to first assessment.

Full Information

First Posted
October 6, 2017
Last Updated
May 7, 2020
Sponsor
Abant Izzet Baysal University
search

1. Study Identification

Unique Protocol Identification Number
NCT03335787
Brief Title
Effectiveness of Kinesio Taping On Balance In Patients With Stroke
Official Title
The Long Term Effects Of Kinesio Taping On Balance In Patients With Stroke: A Single Blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
April 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to investigate the long term effects of Kinesio taping applied on ankle and peroneal muscle in patients with stroke.
Detailed Description
Stroke is a common neurological problem and is one of the major causes of disability and death (1,2). In stroke patients, the mortality rate is approximately 30%, and there is an increase in the morbidity rate after stroke occurrence. In addition, stroke is one of the main factors in increases in the burden of health care expenses during adulthood (3). There is a constant requirement for specific data about stroke rehabilitation methods for achieving evidence-based rehabilitation guidelines.To investigate the effects of repeated correction taping applied on the ankle and peroneus longus and peroneus brevis muscles on balance and gait in patients with stroke. Therefore, the aim of this study is to assess the long term effect of KT applied on ankle and peroneal muscle on both dynamic and static balance in patients with stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Athletic Tape, Proprioception, Hemiplegia, Gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients' information and contact will be obtained from neurologist and willing participant's gender, age and stroke onset data will be processed with a random number generator in order to form groups. Patients will divide into two groups as intervention and control with a normal distribution of gender, age and stroke onset.
Masking
ParticipantOutcomes Assessor
Masking Description
Both group will receive conventional stroke rehabilitation. Intervention group will receive Kinesio taping and control group would not receive a sham taping due to the possible sensory intervention of sham taping even though applying it without any stretch. Outcomes will be recorded by physical therapist using SPSS and groups would not be specified with letter. Statistical analysis will be conducted by another researcher who does not aware of groups given numbers on SPSS.
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Taping will be applied three times and will be reapplied one and two weeks later prior to first application for two weeks.
Arm Title
Control
Arm Type
Other
Arm Description
Control group would not receive any taping in order to prevent sham taping sensory stimulation effect.
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
Kinesio Tape apply to peroneal muscles in supine position starting from the peroneal muscle origin with using muscle activation technique by a certified KT1 and KT2 practitioner. Then ligament technique which will go through around ankle starting from medial and lateral metatarsophalangeal joints in order to improve ankle stability. Taping will be applied one week later and two weeks later prior to first application.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Any sham taping was not applied to the control group in order to prevent the sensory stimulant effect of taping. In order to achieve patients' blinding both groups participant will sign a same consent but control group will be called for taping a month later after study data collection completed.
Primary Outcome Measure Information:
Title
Balance evaluation systems test (BESTest)-Change from Baseline
Description
BESTest contains 27 question under 6 subsections (biomechanical, stability limits, postural responses, anticipatory postural adjustments, sensory orientation, and dynamic balance during gait) all of which rates between 0 (unable) - 3 (normal function) points (22) was used to assess the dynamic and static balance during the activities. TUG was used to assess balance, mobility and walking ability of the patients before and after the procedure as a part of the BESTest. However, as a strong indicator of functional mobility we decided to analyze TUG results separately from the overall BESTest outcomes. Assessments will be conducted at baseline, after first application,one week later and 2 weeks later prior to first assessment.
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Functional reach test (FRT)-Change from Baseline
Description
FRT was used to assess the limits of stability by measuring the distance that a patient can reach forward without losing balance. The test was performed while patient standing on both feet next to a wall. A measurement tape fixed to the wall on the level of patients' acromion. Cut of score was taken as 25 cm. Assessments will be conducted at baseline, after first application,one week later and 2 weeks later prior to first assessment.
Time Frame
two weeks
Title
Tetrax balance systems-Change from Baseline
Description
Tetrax balance system which focuses measuring static balance and postural sways with integrated 4 force plates for tracking weight difference on forefoot and hindfoot. Primary principal of this device is to measure the center of mass and postural sways by using 4 force plates. Assessment was performed while patients standing on the force plates eyes facing forward and without touching anything with their hands. Normal values were taken as 1.0 standard deviation below and 1.5 standard deviation above the mean scores. Higher result related to somato-sensory dysfunction. For weight distribution index it is expected to %25 of total body weight recorded on each plate. Assessments will be conducted at baseline, after first application,one week later and 2 weeks later prior to first assessment.
Time Frame
two weeks
Title
Functional Independence Measure (FIM)-Change from Baseline
Description
Index for measuring both motor and cognitive independency level of patients under total 18 questions. Scores vary from completely independent to completely dependent. Assessments will be conducted at baseline, after first application,one week later and 2 weeks later prior to first assessment.
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing to participate Diagnosed with Stroke Mini-Mental State Test score equal or above 25 Modified Ashworth Scale Score lover then 3 Able to walk 10 meter independently Exclusion Criteria: Secondary neurological diseases Cognitive problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamer Çankaya, Ph.D
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ramazan Kurul, Ms.C
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abant Izzet Baysal University
City
Bolu
ZIP/Postal Code
14100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After publication of article Tetrax balance scores, BESTest results and Timed Up and Go times can be shared with other researches with an excel data sheet. Researchers can contact corresponding researcher with his contact mail and request data.
Citations:
PubMed Identifier
23652265
Citation
Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7. Erratum In: Stroke. 2019 Aug;50(8):e239.
Results Reference
background
PubMed Identifier
22179539
Citation
Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available. Erratum In: Circulation. 2012 Jun 5;125(22):e1002.
Results Reference
background
PubMed Identifier
25072528
Citation
Wardlaw JM, Murray V, Berge E, del Zoppo GJ. Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev. 2014 Jul 29;2014(7):CD000213. doi: 10.1002/14651858.CD000213.pub3.
Results Reference
background
PubMed Identifier
17943737
Citation
Stroke Unit Trialists' Collaboration. Organised inpatient (stroke unit) care for stroke. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD000197. doi: 10.1002/14651858.CD000197.pub2.
Results Reference
background
PubMed Identifier
22228728
Citation
Wade DT. Impact commentaries. Functional abilities after stroke: measurement, natural history and prognosis. J Neurol Neurosurg Psychiatry. 2012 Aug;83(8):770. doi: 10.1136/jnnp-2011-301689. Epub 2012 Jan 6. No abstract available.
Results Reference
background
PubMed Identifier
20813995
Citation
Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
Results Reference
background
PubMed Identifier
11276182
Citation
Geiger RA, Allen JB, O'Keefe J, Hicks RR. Balance and mobility following stroke: effects of physical therapy interventions with and without biofeedback/forceplate training. Phys Ther. 2001 Apr;81(4):995-1005.
Results Reference
background
PubMed Identifier
16214666
Citation
Geurts AC, de Haart M, van Nes IJ, Duysens J. A review of standing balance recovery from stroke. Gait Posture. 2005 Nov;22(3):267-81. doi: 10.1016/j.gaitpost.2004.10.002. Epub 2004 Dec 7.
Results Reference
background
PubMed Identifier
16900045
Citation
Hillier S, Dunsford A. A pilot study of sensory retraining for the hemiparetic foot post-stroke. Int J Rehabil Res. 2006 Sep;29(3):237-42. doi: 10.1097/01.mrr.0000210052.32539.22.
Results Reference
background
PubMed Identifier
15179641
Citation
de Haart M, Geurts AC, Huidekoper SC, Fasotti L, van Limbeek J. Recovery of standing balance in postacute stroke patients: a rehabilitation cohort study. Arch Phys Med Rehabil. 2004 Jun;85(6):886-95. doi: 10.1016/j.apmr.2003.05.012.
Results Reference
background
PubMed Identifier
16172584
Citation
Mauritz KH. Gait training in hemiparetic stroke patients. Eura Medicophys. 2004 Sep;40(3):165-78.
Results Reference
background
PubMed Identifier
18227756
Citation
Slupik A, Dwornik M, Bialoszewski D, Zych E. Effect of Kinesio Taping on bioelectrical activity of vastus medialis muscle. Preliminary report. Ortop Traumatol Rehabil. 2007 Nov-Dec;9(6):644-51. English, Polish.
Results Reference
background
PubMed Identifier
17578750
Citation
Yoshida 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 Reference
background
PubMed Identifier
16987790
Citation
Jaraczewska E, Long C. Kinesio taping in stroke: improving functional use of the upper extremity in hemiplegia. Top Stroke Rehabil. 2006 Summer;13(3):31-42. doi: 10.1310/33KA-XYE3-QWJB-WGT6.
Results Reference
background
PubMed Identifier
8808537
Citation
Robbins S, Waked E, Rappel R. Ankle taping improves proprioception before and after exercise in young men. Br J Sports Med. 1995 Dec;29(4):242-7. doi: 10.1136/bjsm.29.4.242.
Results Reference
background
PubMed Identifier
23777376
Citation
Fayson SD, Needle AR, Kaminski TW. The effects of ankle Kinesio taping on ankle stiffness and dynamic balance. Res Sports Med. 2013;21(3):204-16. doi: 10.1080/15438627.2013.792083.
Results Reference
background
PubMed Identifier
21725170
Citation
Cortesi M, Cattaneo D, Jonsdottir J. Effect of kinesio taping on standing balance in subjects with multiple sclerosis: A pilot study\m1. NeuroRehabilitation. 2011;28(4):365-72. doi: 10.3233/NRE-2011-0665.
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
19424873
Citation
Palluel E, Nougier V, Olivier I. Do spike insoles enhance postural stability and plantar-surface cutaneous sensitivity in the elderly? Age (Dordr). 2008 Mar;30(1):53-61. doi: 10.1007/s11357-008-9047-2. Epub 2008 Mar 4.
Results Reference
background
PubMed Identifier
16515423
Citation
Kilbreath SL, Perkins S, Crosbie J, McConnell J. Gluteal taping improves hip extension during stance phase of walking following stroke. Aust J Physiother. 2006;52(1):53-6. doi: 10.1016/s0004-9514(06)70062-9.
Results Reference
background

Learn more about this trial

Effectiveness of Kinesio Taping On Balance In Patients With Stroke

We'll reach out to this number within 24 hrs