DysphagiaNCT04750174
Kinesiotape and Dysphagia
A study testing Kinesiotaping in people with Dysphagia and Cerebral Palsy, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Dysphagia is common problem in almost all children with cerebral palsy (CP) and there is no consensus about to dysphagia therapy modalities.We aimed to investigate the short- and long-term effects of kinesio taping (KT) on dysphagia in children with CP. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Dysphagia, Cerebral Palsy
- What is being tested?
- Kinesiotaping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2017to Jan 2020
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 2 and 6 years who had oropharyngeal dysphagia (OD) symptom and/or finding and were subsequently hospitalized and rehabilitated were included in this study.
Who cannot join
- Patients with history of maxillary, head or neck surgery or botulinum toxin injection, structural oropharyngeal abnormality, known esophageal dysphagia and/or gastroesophageal reflux disease, who were received medical and/or physical therapy for dysphagia in the last 6 months, using drugs for seizures or spasticity as well as no oral intake and tube dependent completely for feeding were not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Kinesiotape on Children With Cerebral Palsy and Oropharyngeal Dysphagia
Dysphagia is common problem in almost all children with cerebral palsy (CP) and there is no consensus about to dysphagia therapy modalities.We aimed to investigate the short- and long-term effects of kinesio taping (KT) on dysphagia in children with CP.
Read the detailed description
There is a few studies for the effectiveness of KT application in the treatment of dysphagia and its effectiveness is controversial. These small-scale studies conducted to improve control of drooling in the oral phase of swallowing in CP. However, there are no studies that have evaluated swallowing as a whole. Moreover, there is a need to carry out studies evaluating the efficacy of KT in dysphagia treatment with a high level of evidence and duration of effectivenes for a period longer than 3 months. This study is designed to answer the following research questions: "Is KT application effective in the treatment of dysphagia in CP?" ''If it is effective, whether the effect of KT therapy persists more than 3 months''.
- Conditions
- Dysphagia, Cerebral Palsy
- Being tested
- Kinesiotaping
- Keywords
- Kinesiotape, Swallowing, Cerebral Palsy, Dysphagia
- Medical subject headings
- Deglutition Disorders, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
Kinesiotape (KT) has been used by Dr. Kenzo Kase for the first time as based on the opinion that more successful results can be obtained in a banding method similar to the structural characteristics and flexibility of human skin without limiting the joint movements for edema control, joint protection, and proprioception training. In recent years, KT have been applied with a wide variety of techniques including muscle techniques for the inhibition and stimulation of muscles, fascia correction technique which aims to reduce tension and adhesions by making vibration movement between the fascia layers and field correction technique aiming to reduce regional pressure in the presence of pain, inflammation or edema as well as lymphatic correction technique for regulating lymphatic circulation .
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape Group | Active comparator | In active group, KT was applied with stretching to the suprahyoid muscles with right method. Receives: Other: Kinesiotaping |
| Sham Kinesiotape Group | Sham comparator | In sham group, KT was applied without stretching to the suprahyoid region and not including the origins of mylohyoid and digastric muscles Receives: Other: Kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional oral intake scale
The scale evaluates the patient's safe and adequate functional oral intake and consists of 7 levels.
Measured: 6th week
Secondary outcomes (1)
Family satisfaction level
Children's primary caregivers were asked to evaluate the change in swallowing of children at 6th and 18th weeks with 5-point Likert scale. Accordingly, "so much better" to "so much worse" were scored between 1 and 5.
Measured: 18th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study startJan 2017
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Model description
- Patients who met the study criteria were assigned to either the intervention group or the sham group after being questioned to provide their caregivers understanding of all study procedures and requirements for participation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mazlum Serdar Akaltun, University of Gaziantep
- Investigators
- Mazlum Serdar Akaltun, M.D., Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750174
- Sponsor's protocol ID
- MSAkaltun
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Kinesiotape on Children With Cerebral Palsy and Oropharyngeal Dysphagia
- ClinicalTrials.gov ID
- NCT04750174
- Acronym / sponsor ID
- MSAkaltun
- Conditions
- Dysphagia, Cerebral Palsy
- Keywords
- Kinesiotape, Swallowing, Cerebral Palsy, Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 11 Feb 2021 (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.
Dysphagia is common problem in almost all children with cerebral palsy (CP) and there is no consensus about to dysphagia therapy modalities.We aimed to investigate the short- and long-term effects of kinesio taping (KT) on dysphagia in children with CP.
Detailed description
There is a few studies for the effectiveness of KT application in the treatment of dysphagia and its effectiveness is controversial. These small-scale studies conducted to improve control of drooling in the oral phase of swallowing in CP. However, there are no studies that have evaluated swallowing as a whole. Moreover, there is a need to carry out studies evaluating the efficacy of KT in dysphagia treatment with a high level of evidence and duration of effectivenes for a period longer than 3 months. This study is designed to answer the following research questions: "Is KT application effective in the treatment of dysphagia in CP?" ''If it is effective, whether the effect of KT therapy persists more than 3 months''.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients who met the study criteria were assigned to either the intervention group or the sham group after being questioned to provide their caregivers understanding of all study procedures and requirements for participation.
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape Group | Active comparator | Other: KinesiotapingIn active group, KT was applied with stretching to the suprahyoid muscles with right method. |
| Sham Kinesiotape Group | Sham comparator | Other: KinesiotapingIn sham group, KT was applied without stretching to the suprahyoid region and not including the origins of mylohyoid and digastric muscles |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of 2 and 6 years who had oropharyngeal dysphagia (OD) symptom and/or finding and were subsequently hospitalized and rehabilitated were included in this study.
Key exclusion criteria (1 listed)
- Patients with history of maxillary, head or neck surgery or botulinum toxin injection, structural oropharyngeal abnormality, known esophageal dysphagia and/or gastroesophageal reflux disease, who were received medical and/or physical therapy for dysphagia in the last 6 months, using drugs for seizures or spasticity as well as no oral intake and tube dependent completely for feeding were not included.
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 (KT) has been used by Dr. Kenzo Kase for the first time as based on the opinion that more successful results can be obtained in a banding method similar to the structural characteristics and flexibility of human skin without limiting the joint movements for edema control, joint protection, and proprioception training. In recent years, KT have been applied with a wide variety of techniques including muscle techniques for the inhibition and stimulation of muscles, fascia correction technique which aims to reduce tension and adhesions by making vibration movement between the fascia layers and field correction technique aiming to reduce regional pressure in the presence of pain, inflammation or edema as well as lymphatic correction technique for regulating lymphatic circulation . | Other | Kinesiotape Group, Sham Kinesiotape Group |
Primary outcome
Functional oral intake scale
Time frame: 6th week
The scale evaluates the patient's safe and adequate functional oral intake and consists of 7 levels.
1 secondary outcome
Family satisfaction level
Time frame: 18th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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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.
Mazlum Serdar Akaltun, M.D. principal investigator
University of Gaziantep
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 in people with Dysphagia and Cerebral Palsy, run by University of Gaziantep 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional oral intake scale (time frame: 6th week). 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 11 Feb 2021.