Dysphagia, Oropharyngeal, Cerebral PalsyNCT06157489
Effect of Kinesio Tape on Oral and Pharangeal Swallowing Phases in Children With Spastic Cerebral Palsy
A study testing Kinesio tape in people with Dysphagia, Oropharyngeal, Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of current study is to investigate the effect of kinesio tape in children with spastic cerebral palsy having oropharyngeal dysphagia Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Dysphagia, Oropharyngeal, Cerebral Palsy
- What is being tested?
- Kinesio tape
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Jan 2024
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ranges from 3 to 7 years.
- The degree of dysphagia ranges from 4 to 6 level according to functional oral intake scale (appendix II).
- Diagnosed as spastic diplegia or quadriplegia.
- Able to understand and follow instructions.
Who cannot join
- Children will be excluded if they have any of the following criteria:
- Severe visual and auditory problems.
- History of maxillary, head or neck surgical procedures.
- Botulinum toxin treatment of upper esophageal sphincter dysfunction, esophageal dysphagia and/or gastroesophageal reflux disease during the previous six months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Hadeer samy abd elaziz
Tanta
Hadeer Samy Abd elaziz, 01097917913, hadeersamypt@gmail.com
About this study
The purpose of current study is to investigate the effect of kinesio tape in children with spastic cerebral palsy having oropharyngeal dysphagia
Read the detailed description
The study tageted rhe children with spastic cerebral palsy from both sexes will be selected from hospital of Tanta university
Inclusion criteria:
- Age ranges from 2 to 7 years.
- The degree of dysphagia ranges from 4 to 6 level according to functional oral intake scale (appendix II).
- Diagnosed as spastic diplegia or quadriplegia.
- Able to understand and follow instructions.
Exclusion criteria:
Children will be excluded if they have any of the following criteria:
- Severe visual and auditory problems.
- History of maxillary, head or neck surgical procedures.
- Botulinum toxin treatment of upper esophageal sphincter dysfunction, esophageal dysphagia and/or gastroesophageal reflux disease during the previous six months.
- Conditions
- Dysphagia, Oropharyngeal, Cerebral Palsy
- Being tested
- Kinesio tape
- 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.
Kinesio tapeOther
Kinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle
| Study group | Role | What they receive |
|---|---|---|
| Hamza | Active comparator | Not described Receives: Other: Kinesio tape |
| Noor mohamed | Sham comparator | Not described Receives: Other: Kinesio tape |
| Janna ahmed | Active comparator | Not described Receives: Other: Kinesio tape |
| Hamza salah | Active comparator | Not described Receives: Other: Kinesio tape |
| Mohammed asel | Sham comparator | Not described Receives: Other: Kinesio tape |
| Ali ahmed | Active comparator | Not described Receives: Other: Kinesio tape |
| Malek Mohamed | Sham comparator | Not described Receives: Other: Kinesio tape |
| Sayed Mohamed | Active comparator | Not described Receives: Other: Kinesio tape |
| Omar ahmed | Active comparator | Not described Receives: Other: Kinesio tape |
| Ahmed Mohamed | Sham comparator | Not described Receives: Other: Kinesio tape |
| Yousef salah | Sham comparator | Not described Receives: Other: Kinesio tape |
| Rofan ahmed | Active comparator | Not described Receives: Other: Kinesio tape |
| Kinesio tape hasnot assigned to arm group Exercise only | Sham comparator | Not described Receives: Other: Kinesio tape |
| Fareda salah | Active comparator | Not described Receives: Other: Kinesio tape |
| Abd elrahman ahmed | Active comparator | Not described Receives: Other: Kinesio tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral motor assessment sacle
Assessment for oral phase
Measured: 1 month
Secondary outcomes (1)
ultrasonography
Assessment of pharangal phase
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Nov 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia, Oropharyngeal, Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Active Comparator: Kinesiotape Group In active group, KT was applied in masseter muscle, orbicularis oris and infrahyoid muscles for facilitating suprahyoid muscle and oral sensorimotor exercise In sham group will receive the oral sensorimotor exercise only
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Samy Abd Elaziz Alawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157489
- Sponsor's protocol ID
- 004448
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio Tape on Oral and Pharangeal Swallowing Phases in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06157489
- Acronym / sponsor ID
- 004448
- Conditions
- Dysphagia, Oropharyngeal, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 5 Dec 2023 (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.
The purpose of current study is to investigate the effect of kinesio tape in children with spastic cerebral palsy having oropharyngeal dysphagia
Detailed description
The study tageted rhe children with spastic cerebral palsy from both sexes will be selected from hospital of Tanta university
Inclusion criteria:
- Age ranges from 2 to 7 years.
- The degree of dysphagia ranges from 4 to 6 level according to functional oral intake scale (appendix II).
- Diagnosed as spastic diplegia or quadriplegia.
- Able to understand and follow instructions.
Exclusion criteria:
Children will be excluded if they have any of the following criteria:
- Severe visual and auditory problems.
- History of maxillary, head or neck surgical procedures.
- Botulinum toxin treatment of upper esophageal sphincter dysfunction, esophageal dysphagia and/or gastroesophageal reflux disease during the previous six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 15
- Model description
- Active Comparator: Kinesiotape Group In active group, KT was applied in masseter muscle, orbicularis oris and infrahyoid muscles for facilitating suprahyoid muscle and oral sensorimotor exercise In sham group will receive the oral sensorimotor exercise only
| Arm | Type | Receives |
|---|---|---|
| Hamza | Active comparator | Other: Kinesio tape |
| Noor mohamed | Sham comparator | Other: Kinesio tape |
| Janna ahmed | Active comparator | Other: Kinesio tape |
| Hamza salah | Active comparator | Other: Kinesio tape |
| Mohammed asel | Sham comparator | Other: Kinesio tape |
| Ali ahmed | Active comparator | Other: Kinesio tape |
| Malek Mohamed | Sham comparator | Other: Kinesio tape |
| Sayed Mohamed | Active comparator | Other: Kinesio tape |
| Omar ahmed | Active comparator | Other: Kinesio tape |
| Ahmed Mohamed | Sham comparator | Other: Kinesio tape |
| Yousef salah | Sham comparator | Other: Kinesio tape |
| Rofan ahmed | Active comparator | Other: Kinesio tape |
| Kinesio tape hasnot assigned to arm group Exercise only | Sham comparator | Other: Kinesio tape |
| Fareda salah | Active comparator | Other: Kinesio tape |
| Abd elrahman ahmed | Active comparator | Other: Kinesio tape |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age ranges from 3 to 7 years.
- The degree of dysphagia ranges from 4 to 6 level according to functional oral intake scale (appendix II).
- Diagnosed as spastic diplegia or quadriplegia.
- Able to understand and follow instructions.
Key exclusion criteria (4 listed)
- Severe visual and auditory problems.
- History of maxillary, head or neck surgical procedures.
- Botulinum toxin treatment of upper esophageal sphincter dysfunction, esophageal dysphagia and/or gastroesophageal reflux disease during the previous six months.
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 |
|---|---|---|
| Kinesio tapeKinesiotape is applied on masseter muscle, orbi and infrahyoid muscles for facilitating suprahyoid muscle | Other | Abd elrahman ahmed, Ahmed Mohamed, Ali ahmed, Fareda salah, Hamza, Hamza salah, Janna ahmed, Kinesio tape hasnot assigned to arm group Exercise only, Malek Mohamed, Mohammed asel, Noor mohamed, Omar ahmed, Rofan ahmed, Sayed Mohamed, Yousef salah |
Primary outcome
Oral motor assessment sacle
Time frame: 1 month
Assessment for oral phase
1 secondary outcome
ultrasonography
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
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 Kinesio tape in people with Dysphagia, Oropharyngeal, Cerebral Palsy, run by Cairo University at 1 site in Egypt.
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 4 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 5 Dec 2023. 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 Egypt. 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?
Contact Hadeer Samy Abd elaziz (01097917913 ext. Samy, hadeersamypt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral motor assessment sacle (time frame: 1 month). 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 5 Dec 2023.