Taping for Saliva Control in Cerebral Palsy

NCT04252157 | Unknown

• 1 other identifier: KA 19/316
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study aim to investigate the effect of banding on saliva control and quality of life in children with cerebral palsy.

Conditions

Cerebral Palsy

Keywords

saliva; taping

Outcome Measures

Primary Outcomes (3)

• Sociodemographic Features

  Sociodemographic information such as age, gender, height, weight, education level of the parents will be asked.

  baseline

• Saliva Flow Amount

  The drool flow rate of children will be evaluated with DQ5m ("Drooling Quotient 5 minute"). Saliva flow rate can be evaluated by a standard observation of 5 minutes. The test is applied at least 1 hour after eating. Two separate measurements are taken in resting position, at rest and during any activity. The mouth must be empty and clean before the evaluation begins and if there is a saliva it will be removed. The evaluation is done every 15 seconds for 5 minutes and 1 point is given if there is a drooping out of the jaw and / or clothing. If there is no saliva output within 15 seconds, 0 is given. The evaluation is completed in 20 periods. When these periods are completed after 5 minutes, the data obtained are calculated with the formula. The result obtained is interpreted (0 = no new saliva flow 100% = new saliva flow in all periods). The application is valid and reliable.

  2 days after taping

• Intensity and Frequency of Dribble Flow

  The "Saliva Severity and Frequency Scale" will be used to measure the severity and frequency of children's drool flow. Scale dribble intensity 0- No dribble 1- Light dribble (Only wet lips) 2- Moderate dribble (Drip on wet lips and chin) 3- Dribble dribble (Dribble drops to chin, from there to clothes) 4- Too much dribble (Dribble to clothes and objects drips) as a 0-4 score. It ranks the saliva frequency from 0 to 3 as follows; 0. No dribble 1. Rare dribble 2. Frequent dribble 3. Constant flowing dribble. The scale is valid and reliable.

  2 days after taping

Secondary Outcomes (3)

• Posture Evaluation

  2 days after taping

• Evaluation of the Effect on Family

  2 days after taping

• The Gross Motor Function Classification System Assesment

  2 days after taping

Study Arms (3)

kinesiotaping

EXPERIMENTAL

Kinesotape will be apply with suitable tension and necessery region.

Other: Kinesiotaping

plesebo taping

PLACEBO COMPARATOR

Tape will be appy with randomly region without tension.

Other: Plesebo Taping

control

OTHER

Nothing will be applied

Other: Control

Interventions

Kinesiotaping OTHER

Kinesiotape will be applied to the group. During the orbicularis oris muscle, I tape will be applied around the lip with a mechanical correction technique with 50-75% tension. I tape will be applied just below the Hyoid with a 50-75% tension mechanical correlation technique.

kinesiotaping

Plesebo Taping OTHER

An approximately 5 cm I tape will be applied to the group without applying any tension to the temporomandibular attachment for placebo taping.

plesebo taping

Control OTHER

no kinesio or tape will be applied

control

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being a dribble control disorder,
• Having a diagnosis of cerebral palsy,
• Being between the ages of 5-15,
• Not allergic to Kinesio Taping tape.

You may not qualify if:

• Using drugs for saliva control disorder,
• Botulinum toxin has been applied in the last 6 months,
• Active infection (tooth, intestine, etc.),
• Failure to comply with treatment,
• Swallowing disorder.

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Aydan

Ankara, 06790, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof.

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 5, 2020
• Study Start: December 19, 2019
• Primary Completion: October 7, 2020
• Study Completion: March 17, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

TU (1)