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

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03932591
Collaborator
(none)
50
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2
15.1
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Study Details

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
  • Procedure: kinesio taping method
  • Procedure: Sham kinesio taping
N/A

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

Study Type:
Interventional
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 patientsintervention 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 :
Sep 21, 2019
Actual Primary Completion Date :
Dec 16, 2020
Actual Study Completion Date :
Dec 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 Names:
  • 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 Names:
  • Sham antispastic application
  • Outcome Measures

    Primary Outcome Measures

    1. Modified Ashworth Scale [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul Turkey

    Sponsors and Collaborators

    • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    Investigators

    • Principal Investigator: Dilara Ekici Zincirci, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Istanbul Physical Medicine Rehabilitation Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT03932591
    Other Study ID Numbers:
    • IstPMRTRH-KT1
    First Posted:
    Apr 30, 2019
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 5, 2021