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出境医 / 临床实验 / The Effect of Inhibitory Kinesio Taping Application on Spasticity, Stretch Reflex and Motor Neuron Activity

The Effect of Inhibitory Kinesio Taping Application on Spasticity, Stretch Reflex and Motor Neuron Activity

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

Condition or disease Intervention/treatment Phase
Muscle Physiology Procedure: kinesio taping method Procedure: Sham kinesio taping Not Applicable

Detailed Description:

This study will include 78 spastic hemiplegic patient ( 39 controlled, 39 intervention group) Spasticity , Soleus Hmax/Mmax, Soleus T reflex, Soleus H reflex will be evaluated in this study.

Inhibitory kinesio taping method will be used in intervention group for 64-66 hours. Y shaped kinesio tape will be applied on spastic gastrocsoleus muscle. Sham kinesio taping method will be used in controlled group for 64-66 hours. 2 pieces kinesio tape 2,5 cm width, 5 cm length will be applied on gastrocnemius medial and lateral head, 1 piece kinesio tape 5 cm width, 5 cm length will be applied on achilles tendon.

Spasticity, Soleus Hmax/Mmax, Soleus T reflex and H reflex will be measured pre-application (T0), after-application ( in a few minutes) (T1), after 64-66 hours ( with band applied) (T2) and after band removed (T3). Spasticity in both groups will be evaluated with modified ashworth scale.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: intervention group: inhibitory kinesio taping application in spastic hemiplegic patients controlled group: sham kinesio taping application in spastic hemiplegic patients
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Inhibitory Kinesio Taping Application on Severity of Spasticity, Increased Stretch Reflex and Motor Neuron Activity: Prospective, Randomized, Controlled Trials
Actual Study Start Date : September 21, 2019
Actual Primary Completion Date : December 16, 2020
Actual Study Completion Date : December 25, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: intervention
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
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.
Other Name: Antispastic modality
Sham Comparator: Control
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
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
Other Name: Sham antispastic application
Outcome Measures
Primary Outcome Measures :
  1. Modified Ashworth Scale [ Time Frame: 72 hours ]
    Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension)


Secondary Outcome Measures :
  1. Hmax/Mmax rate [ Time Frame: 72 hours ]
    Motor neuron activity will be determined by using the Hmax/Mmax rate. A higher rate indicates higher motor neuron activity.

  2. T-reflex amplitude [ Time Frame: 72 hours ]
    The stretch reflex activity will be evaluated by using T-reflex amplitude. The unit of this variable is microvolts. A higher amplitude indicates higher stretch reflex activity.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations

Locations
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Turkey
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Investigators
Layout table for investigator information
Principal Investigator: Dilara Ekici Zincirci, MD Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Tracking Information
First Submitted Date  ICMJE April 28, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE September 21, 2019
Actual Primary Completion Date December 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2019) 		Modified Ashworth Scale [ Time Frame: 72 hours ]
Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2019)
  • Hmax/Mmax rate [ Time Frame: 72 hours ]
    Motor neuron activity will be determined by using the Hmax/Mmax rate. A higher rate indicates higher motor neuron activity.
  • T-reflex amplitude [ Time Frame: 72 hours ]
    The stretch reflex activity will be evaluated by using T-reflex amplitude. The unit of this variable is microvolts. A higher amplitude indicates higher stretch reflex activity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Inhibitory Kinesio Taping Application on Spasticity, Stretch Reflex and Motor Neuron Activity
Official Title  ICMJE The Effect of Inhibitory Kinesio Taping Application on Severity of Spasticity, Increased Stretch Reflex and Motor Neuron Activity: Prospective, Randomized, Controlled Trials
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. Inhibitory kinesio taping application can reduced spasticity
  2. Inhibitory kinesio taping application can reduced motor neuron activity and stretch reflex
Detailed Description

This study will include 78 spastic hemiplegic patient ( 39 controlled, 39 intervention group) Spasticity , Soleus Hmax/Mmax, Soleus T reflex, Soleus H reflex will be evaluated in this study.

Inhibitory kinesio taping method will be used in intervention group for 64-66 hours. Y shaped kinesio tape will be applied on spastic gastrocsoleus muscle. Sham kinesio taping method will be used in controlled group for 64-66 hours. 2 pieces kinesio tape 2,5 cm width, 5 cm length will be applied on gastrocnemius medial and lateral head, 1 piece kinesio tape 5 cm width, 5 cm length will be applied on achilles tendon.

Spasticity, Soleus Hmax/Mmax, Soleus T reflex and H reflex will be measured pre-application (T0), after-application ( in a few minutes) (T1), after 64-66 hours ( with band applied) (T2) and after band removed (T3). Spasticity in both groups will be evaluated with modified ashworth scale.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
intervention group: inhibitory kinesio taping application in spastic hemiplegic patients controlled group: sham kinesio taping application in spastic hemiplegic patients
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Muscle Physiology
Intervention  ICMJE
  • Procedure: kinesio taping method
    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.
    Other Name: Antispastic modality
  • Procedure: Sham kinesio taping
    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
    Other Name: Sham antispastic application
Study Arms  ICMJE
  • Experimental: intervention
    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.
    Intervention: Procedure: kinesio taping method
  • Sham Comparator: Control
    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.
    Intervention: Procedure: Sham kinesio taping
Publications *
  • 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. Review.
  • 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.
  • 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.
  • 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.
  • 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. Epub 2006 Dec 22.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2021) 		50
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2019) 		78
Actual Study Completion Date  ICMJE December 25, 2020
Actual Primary Completion Date December 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03932591
Other Study ID Numbers  ICMJE IstPMRTRH-KT1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study Sponsor  ICMJE Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dilara Ekici Zincirci, MD Istanbul Physical Medicine Rehabilitation Training and Research Hospital
PRS Account Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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