Kinesiotape and Dysphagia

NCT04750174 | Completed

• 1 other identifier: MSAkaltun
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia; Cerebral Palsy

Keywords

Kinesiotape; Swallowing; Cerebral Palsy; Dysphagia

Outcome Measures

Primary Outcomes (1)

• Functional oral intake scale

  The scale evaluates the patient's safe and adequate functional oral intake and consists of 7 levels.

  6th week

Secondary Outcomes (1)

• Family satisfaction level

  18th week

Study Arms (2)

Kinesiotape Group

ACTIVE COMPARATOR

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

Other: Kinesiotaping

Sham Kinesiotape Group

SHAM COMPARATOR

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

Other: Kinesiotaping

Interventions

Kinesiotaping 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 .

Kinesiotape Group; Sham Kinesiotape Group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University

Gaziantep, 27300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deglutition Disorders; Cerebral Palsy

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mazlum Serdar Akaltun, M.D.

  University of Gaziantep

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A short practical training was performed before the study. The study was performed by a group of independent specialists blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 11, 2021
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

TU (1)