Taping for Saliva Control in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04252157
• Other study ID #: KA 19/316
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: March 17, 2021

Study information

• Verified date: March 2021
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 17, 2021
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• 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.
• Control
no kinesio or tape will be applied

Locations

Country	Name	City	State
Turkey	Aydan	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sociodemographic Features	Sociodemographic information such as age, gender, height, weight, education level of the parents will be asked.	baseline
Primary	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
Primary	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	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
Secondary	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
Secondary	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