Cerebral PalsyNCT04252157
Taping for Saliva Control in Cerebral Palsy
A study testing Kinesiotaping and Plesebo Taping in people with Cerebral Palsy, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This study aim to investigate the effect of banding on saliva control and quality of life in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Kinesiotaping and Plesebo Taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2019to 17 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being a dribble control disorder,
- Having a diagnosis of cerebral palsy,
- Being between the ages of 5-15,
- Not allergic to Kinesio Taping tape.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydan
Ankara, 06790
aydan aytar, +905071535028, aytara@baskent.edu.tr
Nilsah Geboloğlu
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Kinesiotaping, Plesebo Taping, Control
- Keywords
- saliva, taping
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
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 TapingOther
An approximately 5 cm I tape will be applied to the group without applying any tension to the temporomandibular attachment for placebo taping.
ControlOther
no kinesio or tape will be applied
| Study group | Role | What they receive |
|---|---|---|
| kinesiotaping | Experimental | Kinesotape will be apply with suitable tension and necessery region. Receives: Other: Kinesiotaping |
| plesebo taping | Placebo comparator | Tape will be appy with randomly region without tension. Receives: Other: Plesebo Taping |
| control | Other | Nothing will be applied Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic Features
Sociodemographic information such as age, gender, height, weight, education level of the parents will be asked.
Measured: 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.
Measured: 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.
Measured: 2 days after taping
Secondary outcomes (3)
Posture Evaluation
Posture evaluation will be done observationally. In this evaluation, anterior, posterior and lateral head, neck, and trunk posture will be evaluated.
Measured: 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.
Measured: 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.
Measured: 2 days after taping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start19 Dec 2019
- Primary completion7 Oct 2020
- Study completion17 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aydan aytar, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252157
- Sponsor's protocol ID
- KA 19/316
- Status last verified
- Mar 2021
- First submitted
- 27 Jan 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesiotaping on Saliva Control in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04252157
- Acronym / sponsor ID
- KA 19/316
- Conditions
- Cerebral Palsy
- Keywords
- saliva, taping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 17 Mar 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| kinesiotaping | Experimental | Other: KinesiotapingKinesotape will be apply with suitable tension and necessery region. |
| plesebo taping | Placebo comparator | Other: Plesebo TapingTape will be appy with randomly region without tension. |
| control | Other | Other: ControlNothing will be applied |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being a dribble control disorder,
- Having a diagnosis of cerebral palsy,
- Being between the ages of 5-15,
- Not allergic to Kinesio Taping tape.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KinesiotapingKinesiotape 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. | Other | kinesiotaping |
| Plesebo TapingAn approximately 5 cm I tape will be applied to the group without applying any tension to the temporomandibular attachment for placebo taping. | Other | plesebo taping |
| Controlno kinesio or tape will be applied | Other | control |
Primary outcome
Sociodemographic Features
Time frame: baseline
Sociodemographic information such as age, gender, height, weight, education level of the parents will be asked.
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.
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.
3 secondary outcomes
Posture Evaluation
Time frame: 2 days after taping
Evaluation of the Effect on Family
Time frame: 2 days after taping
The Gross Motor Function Classification System Assesment
Time frame: 2 days after taping
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping and Plesebo Taping in people with Cerebral Palsy, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic Features (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.