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Effectiveness of Kinesio Taping On Balance In Patients With Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335787
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Ramazan KURUL, Abant Izzet Baysal University

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.

Condition or disease Intervention/treatment Phase
Stroke Other: Intervention Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes 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.

Primary Purpose: Treatment
Official Title: The Long Term Effects Of Kinesio Taping On Balance In Patients With Stroke: A Single Blinded Randomized Controlled Trial
Actual Study Start Date : November 20, 2017
Actual Primary Completion Date : March 15, 2018
Actual Study Completion Date : April 20, 2018

Arm Intervention/treatment
Experimental: Intervention
Taping will be applied three times and will be reapplied one and two weeks later prior to first application for two weeks.
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
Control group would not receive any taping in order to prevent sham taping sensory stimulation effect.
Other: 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.




Primary Outcome Measures :
  1. Balance evaluation systems test (BESTest)-Change from Baseline [ Time Frame: two weeks ]
    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 :
  1. Functional reach test (FRT)-Change from Baseline [ Time Frame: two weeks ]
    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.

  2. Tetrax balance systems-Change from Baseline [ Time Frame: two weeks ]
    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.

  3. Functional Independence Measure (FIM)-Change from Baseline [ Time Frame: two weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335787


Locations
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Turkey
Abant Izzet Baysal University
Bolu, Turkey, 14100
Sponsors and Collaborators
Abant Izzet Baysal University
Investigators
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Study Director: Tamer Çankaya, Ph.D Abant Izzet Baysal University
Principal Investigator: Ramazan Kurul, Ms.C Abant Izzet Baysal University
Publications:
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.

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Responsible Party: Ramazan KURUL, Assistant Professor, Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT03335787    
Other Study ID Numbers: AbantIBU-Phys1
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ramazan KURUL, Abant Izzet Baysal University:
Athletic Tape
Proprioception
Hemiplegia
Gait
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases