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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04750174
Other study ID # MSAkaltun
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date January 2020

Study information

Verified date February 2021
Source University of Gaziantep
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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''.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group 2 Years to 6 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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 .

Locations

Country Name City State
Turkey Gaziantep University Gaziantep

Sponsors (1)

Lead Sponsor Collaborator
University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional oral intake scale The scale evaluates the patient's safe and adequate functional oral intake and consists of 7 levels. 6th week
Secondary Family satisfaction level Children's primary caregivers were asked to evaluate the change in swallowing of children at 6th and 18th weeks with 5-point Likert scale. Accordingly, "so much better" to "so much worse" were scored between 1 and 5. 18th week
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