Clinical trial NCT03932591: 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
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Physiology
Keywords: Spasticity
kinesio tape
stretch reflex
H-reflex
T-reflex
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-04-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention group: inhibitory kinesio taping application in spastic hemiplegic patients controlled group: sham kinesio taping application in spastic hemiplegic patients
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: 72 hours
Secondary outcomes:
measure: Hmax/Mmax rate
timeFrame: 72 hours
measure: T-reflex amplitude
timeFrame: 72 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
name: Dilara Ekici Zincirci, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.