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

Primary Purpose

Muscle Physiology

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
kinesio taping method
Sham kinesio taping
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Physiology focused on measuring Spasticity, kinesio tape, stretch reflex, H-reflex, T-reflex

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hmax/Mmax rate
Motor neuron activity will be determined by using the Hmax/Mmax rate. A higher rate indicates higher motor neuron activity.
T-reflex amplitude
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.

Full Information

First Posted
April 28, 2019
Last Updated
January 4, 2021
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03932591
Brief Title
The Effect of Inhibitory Kinesio Taping Application on Spasticity, Stretch Reflex and Motor Neuron Activity
Official Title
The Effect of Inhibitory Kinesio Taping Application on Severity of Spasticity, Increased Stretch Reflex and Motor Neuron Activity: Prospective, Randomized, Controlled Trials
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 21, 2019 (Actual)
Primary Completion Date
December 16, 2020 (Actual)
Study Completion Date
December 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 Inhibitory kinesio taping application can reduced spasticity 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Physiology
Keywords
Spasticity, kinesio tape, stretch reflex, H-reflex, T-reflex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
intervention group: inhibitory kinesio taping application in spastic hemiplegic patients controlled group: sham kinesio taping application in spastic hemiplegic patients
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
kinesio taping method
Other Intervention Name(s)
Antispastic modality
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham kinesio taping
Other Intervention Name(s)
Sham antispastic application
Intervention Description
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
Primary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension)
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Hmax/Mmax rate
Description
Motor neuron activity will be determined by using the Hmax/Mmax rate. A higher rate indicates higher motor neuron activity.
Time Frame
72 hours
Title
T-reflex amplitude
Description
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.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilara Ekici Zincirci, MD
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25914638
Citation
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.
Results Reference
background
PubMed Identifier
30100319
Citation
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.
Results Reference
background
PubMed Identifier
20826420
Citation
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.
Results Reference
background
PubMed Identifier
24910607
Citation
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.
Results Reference
background
PubMed Identifier
17188548
Citation
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.
Results Reference
background
PubMed Identifier
28532863
Citation
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.
Results Reference
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The Effect of Inhibitory Kinesio Taping Application on Spasticity, Stretch Reflex and Motor Neuron Activity

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