NCT03335787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2013

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2018

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4.3 years

First QC Date

October 6, 2017

Last Update Submit

February 27, 2024

Conditions

Keywords

Athletic TapeProprioceptionHemiplegiaGait

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Functional reach test (FRT)-Change from Baseline

    two weeks

  • Tetrax balance systems-Change from Baseline

    two weeks

  • Functional Independence Measure (FIM)-Change from Baseline

    two weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Intervention

Control

OTHER

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

Other: Control

Interventions

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
ControlOTHER

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.

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Secondary neurological diseases
  • Cognitive problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

Location

Related Publications (20)

  • 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.

    PMID: 23652265BACKGROUND
  • 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.

    PMID: 22179539BACKGROUND
  • 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.

    PMID: 25072528BACKGROUND
  • 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.

    PMID: 17943737BACKGROUND
  • 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.

    PMID: 22228728BACKGROUND
  • 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.

    PMID: 20813995BACKGROUND
  • 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.

    PMID: 11276182BACKGROUND
  • 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.

    PMID: 16214666BACKGROUND
  • 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.

    PMID: 16900045BACKGROUND
  • 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.

    PMID: 15179641BACKGROUND
  • Mauritz KH. Gait training in hemiparetic stroke patients. Eura Medicophys. 2004 Sep;40(3):165-78.

    PMID: 16172584BACKGROUND
  • 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.

    PMID: 18227756BACKGROUND
  • 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.

    PMID: 17578750BACKGROUND
  • 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.

    PMID: 16987790BACKGROUND
  • 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.

    PMID: 8808537BACKGROUND
  • 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.

    PMID: 23777376BACKGROUND
  • 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.

    PMID: 21725170BACKGROUND
  • 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.

    PMID: 26409338BACKGROUND
  • 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.

    PMID: 19424873BACKGROUND
  • 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.

    PMID: 16515423BACKGROUND

MeSH Terms

Conditions

StrokeHemiplegia

Interventions

Methods

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Tamer Çankaya, Ph.D

    Abant Izzet Baysal University

    STUDY DIRECTOR
  • Ramazan Kurul, Ms.C

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 6, 2017

First Posted

November 8, 2017

Study Start

November 20, 2013

Primary Completion

March 15, 2018

Study Completion

April 20, 2018

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

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.

Locations