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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03932591
Other study ID # IstPMRTRH-KT1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 21, 2019
Est. completion date December 25, 2020

Study information

Verified date January 2021
Source Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 25, 2020
Est. primary completion date December 16, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Turkey Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Hmax/Mmax rate Motor neuron activity will be determined by using the Hmax/Mmax rate. A higher rate indicates higher motor neuron activity. 72 hours
Secondary 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. 72 hours
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