NCT04105322

Brief Summary

This study is planned to investigate the acute effects of trunk kinesio taping on balance and functional performance in acute stroke patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Status
unknown

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

September 1, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

September 23, 2019

Last Update Submit

September 24, 2019

Conditions

Keywords

Acute strokeBalanceRehabilitationPostural control

Outcome Measures

Primary Outcomes (3)

  • 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.

    Change of trunk impairment from baseline at the end of 48 hours of each kinesio taping intervention.

  • 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.

    Change of balance scores from baseline at the end of 48 hours of each kinesio taping intervention.

  • 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.

    Change of functional performance scores from baseline at the end of 48 hours of each kinesio taping intervention.

Secondary Outcomes (3)

  • Wii Balance Board

    Change of balance scores from baseline at the end of 48 hours of each kinesio taping intervention.

  • Postural Assessment Scale for Stroke

    Change of postural ability from baseline at the end of 48 hours of each kinesio taping intervention.

  • Patient Satisfaction: Visual Analogue Scale (VAS)

    Change of patient satisfaction at the end of 48 hours of each kinesio taping application.

Study Arms (3)

Kinesio Taping on Abdominal Muscles

EXPERIMENTAL
Other: Kinesio Taping

Kinesio Taping on Back Muscles

EXPERIMENTAL
Other: Kinesio Taping

Control

NO INTERVENTION

Interventions

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.

Kinesio Taping on Abdominal MusclesKinesio Taping on Back Muscles

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 27630439BACKGROUND
  • 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
  • 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.

    PMID: 31003662BACKGROUND
  • 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.

    PMID: 26321149BACKGROUND
  • 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.

    PMID: 14758293BACKGROUND

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Asalet Aybüke GÜP, Bachelor

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR
  • Banu BAYAR, Doctorate

    Muğla Sıtkı Koçman University

    STUDY DIRECTOR

Central Study Contacts

Asalet Aybüke GÜP, Bachelor

CONTACT

Banu BAYAR, Doctorate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 26, 2019

Study Start

September 1, 2019

Primary Completion

March 1, 2020

Study Completion

May 1, 2020

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share