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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03335787
Other study ID # AbantIBU-Phys1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2013
Est. completion date April 20, 2018

Study information

Verified date February 2024
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date April 20, 2018
Est. primary completion date March 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intervention
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.
Control
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.

Locations

Country Name City State
Turkey Abant Izzet Baysal University Bolu

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

References & Publications (20)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Mauritz KH. Gait training in hemiparetic stroke patients. Eura Medicophys. 2004 Sep;40(3):165-78. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 20 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. two weeks
Secondary 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. two weeks
Secondary 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. two weeks
Secondary 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. two weeks
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