Kinesiotape and Dysphagia

NCT ID: NCT04750174

Last Updated: 2021-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-01-31

Brief Summary

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Dysphagia is common problem in almost all children with cerebral palsy (CP) and there is no consensus about to dysphagia therapy modalities.We aimed to investigate the short- and long-term effects of kinesio taping (KT) on dysphagia in children with CP.

Detailed Description

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There is a few studies for the effectiveness of KT application in the treatment of dysphagia and its effectiveness is controversial. These small-scale studies conducted to improve control of drooling in the oral phase of swallowing in CP. However, there are no studies that have evaluated swallowing as a whole. Moreover, there is a need to carry out studies evaluating the efficacy of KT in dysphagia treatment with a high level of evidence and duration of effectivenes for a period longer than 3 months. This study is designed to answer the following research questions: "Is KT application effective in the treatment of dysphagia in CP?" ''If it is effective, whether the effect of KT therapy persists more than 3 months''.

Conditions

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Dysphagia Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients who met the study criteria were assigned to either the intervention group or the sham group after being questioned to provide their caregivers understanding of all study procedures and requirements for participation.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
A short practical training was performed before the study. The study was performed by a group of independent specialists blinded to treatment allocation.

Study Groups

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Kinesiotape Group

In active group, KT was applied with stretching to the suprahyoid muscles with right method.

Group Type ACTIVE_COMPARATOR

Kinesiotaping

Intervention Type OTHER

Kinesiotape (KT) has been used by Dr. Kenzo Kase for the first time as based on the opinion that more successful results can be obtained in a banding method similar to the structural characteristics and flexibility of human skin without limiting the joint movements for edema control, joint protection, and proprioception training. In recent years, KT have been applied with a wide variety of techniques including muscle techniques for the inhibition and stimulation of muscles, fascia correction technique which aims to reduce tension and adhesions by making vibration movement between the fascia layers and field correction technique aiming to reduce regional pressure in the presence of pain, inflammation or edema as well as lymphatic correction technique for regulating lymphatic circulation .

Sham Kinesiotape Group

In sham group, KT was applied without stretching to the suprahyoid region and not including the origins of mylohyoid and digastric muscles

Group Type SHAM_COMPARATOR

Kinesiotaping

Intervention Type OTHER

Kinesiotape (KT) has been used by Dr. Kenzo Kase for the first time as based on the opinion that more successful results can be obtained in a banding method similar to the structural characteristics and flexibility of human skin without limiting the joint movements for edema control, joint protection, and proprioception training. In recent years, KT have been applied with a wide variety of techniques including muscle techniques for the inhibition and stimulation of muscles, fascia correction technique which aims to reduce tension and adhesions by making vibration movement between the fascia layers and field correction technique aiming to reduce regional pressure in the presence of pain, inflammation or edema as well as lymphatic correction technique for regulating lymphatic circulation .

Interventions

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Kinesiotaping

Kinesiotape (KT) has been used by Dr. Kenzo Kase for the first time as based on the opinion that more successful results can be obtained in a banding method similar to the structural characteristics and flexibility of human skin without limiting the joint movements for edema control, joint protection, and proprioception training. In recent years, KT have been applied with a wide variety of techniques including muscle techniques for the inhibition and stimulation of muscles, fascia correction technique which aims to reduce tension and adhesions by making vibration movement between the fascia layers and field correction technique aiming to reduce regional pressure in the presence of pain, inflammation or edema as well as lymphatic correction technique for regulating lymphatic circulation .

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children between the ages of 2 and 6 years who had oropharyngeal dysphagia (OD) symptom and/or finding and were subsequently hospitalized and rehabilitated were included in this study.

Exclusion Criteria

* Patients with history of maxillary, head or neck surgery or botulinum toxin injection, structural oropharyngeal abnormality, known esophageal dysphagia and/or gastroesophageal reflux disease, who were received medical and/or physical therapy for dysphagia in the last 6 months, using drugs for seizures or spasticity as well as no oral intake and tube dependent completely for feeding were not included.
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Gaziantep

OTHER

Sponsor Role lead

Responsible Party

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Mazlum Serdar Akaltun

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mazlum Serdar Akaltun, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Gaziantep

Locations

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Gaziantep University

Gaziantep, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MSAkaltun

Identifier Type: -

Identifier Source: org_study_id

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