Taping for Saliva Control in Cerebral Palsy

The Effect of Kinesiotaping on Saliva Control in Children With Cerebral Palsy

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

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Kinesiotaping; Other: Plesebo Taping; Other: Control

Detailed Description

Cerebral palsy describes a whole set of permanent disorders or disorders in the development of movement and posture, attributed to non-progressive disorders occurring in the developing fetal or infant brain, causing activity limitation. Motor disorders are often accompanied by sensory, perception, communication and behavioral disorders, epilepsy and secondary musculoskeletal problems.

Kinesio Taping has been proven to increase local circulation, reduce local edema and provide a positional stimulus for muscle, skin, or facial structures, regulating sensory input, and activating regions in the brain. KT is currently used to improve oral control in children with neurological and neuromuscular disorders and provides a reduction in saliva flow and frequency. However, knowledge of the potential of using neuromuscular bandages to manage the dribble flow has been limited.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06790
    • Recruiting
    • Aydan
    • Contact: aydan aytar; Phone Number: +905071535028; Email: aytara@baskent.edu.tr
    • Principal Investigator: Nilsah Geboloğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: kinesiotaping; Kinesotape will be apply with suitable tension and necessery region.	Other: Kinesiotaping; 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.
Placebo Comparator: plesebo taping; Tape will be appy with randomly region without tension.	Other: Plesebo Taping; An approximately 5 cm I tape will be applied to the group without applying any tension to the temporomandibular attachment for placebo taping.
Other: control; Nothing will be applied	Other: Control; no kinesio or tape will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posture Evaluation	Posture evaluation will be done observationally. In this evaluation, anterior, posterior and lateral head, neck, and trunk posture will be evaluated.	2 days after taping
Evaluation of the Effect on Family	"Family Impact Scale" will be used to evaluate the effect of drool control disorder in children on the family. The scale, which consists of financial burden, familial and social impact, personal strain and coping sub parameters, is applied by answering the judgments about these parameters, fully agree, disagree and disagree at all. According to the total score received, comments are made about the level of influence of the family. A minimum score of 24 and a maximum of 96 can be obtained from the scale. The items in the scale are generally related to social, financial and emotional areas, and the high scale score indicates that the problem of mothers is high.The test is valid and reliable.	2 days after taping
The Gross Motor Function Classification System Assesment	The Gross Motor Function Classification System Assesment will be used to determine the level of cerebral palsy on the basis of self-initiated movement abilities.	2 days after taping

Collaborators and Investigators

• Sponsor: Baskent University

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): October 7, 2020
• Study Completion (Anticipated): March 17, 2021

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: taping; saliva
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: KA 19/316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No