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Taping for Saliva Control in Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04252157
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : July 9, 2020
Information provided by (Responsible Party):
aydan aytar, Baskent University

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

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Kinesiotaping Other: Plesebo Taping Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Kinesiotaping on Saliva Control in Children With Cerebral Palsy
Actual Study Start Date : December 19, 2019
Estimated Primary Completion Date : July 7, 2020
Estimated Study Completion Date : July 10, 2020

Resource links provided by the National Library of Medicine

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.

Nothing will be applied
Other: Control
no kinesio or tape will be applied

Primary Outcome Measures :
  1. Sociodemographic Features [ Time Frame: baseline ]
    Sociodemographic information such as age, gender, height, weight, education level of the parents will be asked.

  2. Saliva Flow Amount [ Time Frame: 2 days after taping ]
    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.

  3. Intensity and Frequency of Dribble Flow [ Time Frame: 2 days after taping ]
    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 :
  1. Posture Evaluation [ Time Frame: 2 days after taping ]
    Posture evaluation will be done observationally. In this evaluation, anterior, posterior and lateral head, neck, and trunk posture will be evaluated.

  2. Evaluation of the Effect on Family [ Time Frame: 2 days after taping ]
    "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.

  3. The Gross Motor Function Classification System Assesment [ Time Frame: 2 days after taping ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04252157

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Aydan Recruiting
Ankara, Turkey, 06790
Contact: aydan aytar    +905071535028   
Principal Investigator: Nilsah Geboloğlu         
Sponsors and Collaborators
Baskent University
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Responsible Party: aydan aytar, assoc. prof., Baskent University Identifier: NCT04252157    
Other Study ID Numbers: KA 19/316
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by aydan aytar, Baskent University:
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases