NCT03932591

Brief Summary

The first aim of this study is whether the inhibitory kinesio taping application can reduce spasticity. The second aim of this study is to investigate whether the kinesio taping application have neuromodulatory activity on motor neuron and stretch reflex. Hypotheses of this study: unlike healthy cases, in patients with spastic hemiplegia

  1. 1.Inhibitory kinesio taping application can reduced spasticity
  2. 2.Inhibitory kinesio taping application can reduced motor neuron activity and stretch reflex

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

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

First Submitted

Initial submission to the registry

April 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 21, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

April 28, 2019

Last Update Submit

January 4, 2021

Conditions

Keywords

Spasticitykinesio tapestretch reflexH-reflexT-reflex

Outcome Measures

Primary Outcomes (1)

  • Modified Ashworth Scale

    Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension)

    72 hours

Secondary Outcomes (2)

  • Hmax/Mmax rate

    72 hours

  • T-reflex amplitude

    72 hours

Study Arms (2)

intervention

EXPERIMENTAL

Inhibitory kinesio taping method will be used for intervention group. Y shaped, 34-40 cm length, 5 cm width, skin color kinesio tape will be applied on spastic gastrocsoleus muscle. The base of Y shaped tape will be strapped on calcaneus ( no stretch for first 5 cm) and the both legs of Y shaped tape will be strapped on gastrocnemius muscle medial and lateral head with 15% stretch.

Procedure: kinesio taping method

Control

SHAM COMPARATOR

Sham kinesio tape will be used for controlled group. 2,5 cm width, 5 cm length, skin color 2 pieces kinesio tape will be applied on medial and lateral head of gastrocnemius muscle without stretch. 5 cm length, 5 cm width, skin color 1 piece kinesio tape will be applied on achilles tendon without stretch.

Procedure: Sham kinesio taping

Interventions

Kinesio tape is an elastic, adhesive, hypo-allergenic, latex-free tape. Kinesio taping method is rehabilitative taping technique. One of the purposes of this technique is to facilitate or inhibit the muscles.

Also known as: Antispastic modality
intervention

Sham kinesio tape will be used for controlled group. 2,5 cm width, 5 cm length, skin color 2 pieces kinesio tape will be applied on medial and lateral head of gastrocnemius muscle without stretch. 5 cm length, 5 cm width, skin color 1 piece kinesio tape will be a

Also known as: Sham antispastic application
Control

Eligibility Criteria

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

You may qualify if:

  • Unilateral ischemic/hemorrhagic stroke
  • First stroke attack
  • Gastrocsoleus muscle spasticity ( Modified Ashworth Scale 1-3)

You may not qualify if:

  • Perform surgery from the related limb
  • Skin problems, wounds and infections
  • Allergy to the kinesio tape material
  • Antispastic drug use
  • Contracture in gastrocsoleus muscle or antagonists
  • Peripheral nerve lesion in the lower extremity
  • II.Motor neuron diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • Li S, Francisco GE. New insights into the pathophysiology of post-stroke spasticity. Front Hum Neurosci. 2015 Apr 10;9:192. doi: 10.3389/fnhum.2015.00192. eCollection 2015.

    PMID: 25914638BACKGROUND
  • Qafarizadeh F, Kalantari M, Ansari NN, Baghban AA, Jamebozorgi A. The effect of kinesiotaping on hand function in stroke patients: A pilot study. J Bodyw Mov Ther. 2018 Jul;22(3):829-831. doi: 10.1016/j.jbmt.2017.09.015. Epub 2017 Sep 23.

    PMID: 30100319BACKGROUND
  • Karadag-Saygi E, Cubukcu-Aydoseli K, Kablan N, Ofluoglu D. The role of kinesiotaping combined with botulinum toxin to reduce plantar flexors spasticity after stroke. Top Stroke Rehabil. 2010 Jul-Aug;17(4):318-22. doi: 10.1310/tsr1704-318.

    PMID: 20826420BACKGROUND
  • Tamburella F, Scivoletto G, Molinari M. Somatosensory inputs by application of KinesioTaping: effects on spasticity, balance, and gait in chronic spinal cord injury. Front Hum Neurosci. 2014 May 30;8:367. doi: 10.3389/fnhum.2014.00367. eCollection 2014.

    PMID: 24910607BACKGROUND
  • Alexander CM, McMullan M, Harrison PJ. What is the effect of taping along or across a muscle on motoneurone excitability? A study using triceps surae. Man Ther. 2008 Feb;13(1):57-62. doi: 10.1016/j.math.2006.08.003. Epub 2006 Dec 22.

    PMID: 17188548BACKGROUND
  • Yoosefinejad AK, Motealleh A, Abbasalipur S, Shahroei M, Sobhani S. Can inhibitory and facilitatory kinesiotaping techniques affect motor neuron excitability? A randomized cross-over trial. J Bodyw Mov Ther. 2017 Apr;21(2):234-239. doi: 10.1016/j.jbmt.2016.06.011. Epub 2016 Jun 17.

    PMID: 28532863BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dilara Ekici Zincirci, MD

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: intervention group: inhibitory kinesio taping application in spastic hemiplegic patients controlled group: sham kinesio taping application in spastic hemiplegic patients
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2019

First Posted

April 30, 2019

Study Start

September 21, 2019

Primary Completion

December 16, 2020

Study Completion

December 25, 2020

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations