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Taping for Saliva Control in Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotaping
Plesebo Taping
Control
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring saliva, taping

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AydanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

kinesiotaping

plesebo taping

control

Arm Description

Kinesotape will be apply with suitable tension and necessery region.

Tape will be appy with randomly region without tension.

Nothing will be applied

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Posture Evaluation
Posture evaluation will be done observationally. In this evaluation, anterior, posterior and lateral head, neck, and trunk posture will be evaluated.
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.
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.

Full Information

First Posted
January 27, 2020
Last Updated
March 17, 2021
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT04252157
Brief Title
Taping for Saliva Control in Cerebral Palsy
Official Title
The Effect of Kinesiotaping on Saliva Control in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
March 17, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
saliva, taping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
kinesiotaping
Arm Type
Experimental
Arm Description
Kinesotape will be apply with suitable tension and necessery region.
Arm Title
plesebo taping
Arm Type
Placebo Comparator
Arm Description
Tape will be appy with randomly region without tension.
Arm Title
control
Arm Type
Other
Arm Description
Nothing will be applied
Intervention Type
Other
Intervention Name(s)
Kinesiotaping
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Plesebo Taping
Intervention Description
An approximately 5 cm I tape will be applied to the group without applying any tension to the temporomandibular attachment for placebo taping.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
no kinesio or tape will be applied
Primary Outcome Measure Information:
Title
Sociodemographic Features
Description
Sociodemographic information such as age, gender, height, weight, education level of the parents will be asked.
Time Frame
baseline
Title
Saliva Flow Amount
Description
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.
Time Frame
2 days after taping
Title
Intensity and Frequency of Dribble Flow
Description
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.
Time Frame
2 days after taping
Secondary Outcome Measure Information:
Title
Posture Evaluation
Description
Posture evaluation will be done observationally. In this evaluation, anterior, posterior and lateral head, neck, and trunk posture will be evaluated.
Time Frame
2 days after taping
Title
Evaluation of the Effect on Family
Description
"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.
Time Frame
2 days after taping
Title
The Gross Motor Function Classification System Assesment
Description
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.
Time Frame
2 days after taping

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Aydan
City
Ankara
ZIP/Postal Code
06790
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
aydan aytar
Phone
+905071535028
Email
aytara@baskent.edu.tr
First Name & Middle Initial & Last Name & Degree
Nilsah Geboloğlu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Taping for Saliva Control in Cerebral Palsy

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