DroolingNCT05524831
Kinesio Taping Versus Oromotor Training on Drooling in Children With Spastic Cerebral Palsy
A study testing KINESIOTAPE and oromotor training in people with Drooling and Kinesiotape, run by Cairo University at 1 site in Egypt.
Trial summary
Statement of the problem : Which is more effective for treatment of drooling in children with spastic cerebral palsy; kinesio taping or oromotor training? Null Hypothesis: There will be no difference between the effectiveness of kinesio taping and oromotor training on drooling in children with spastic cp. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Drooling, Kinesiotape, Cerebral Palsy
- What is being tested?
- KINESIOTAPE and oromotor training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2021to 11 Aug 2022
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A diagnosis of spastic cerebral palsy with drooling problem.
- The age of the selected children will range from 4to 8 years old.
- Severe degree of drooling according to Drooling Severity and Frequency Scale.
- Child with good head control
Who cannot join
- Congenital problems of mouth and soft palate such as cleft lip and palate, jaw anomalies and salivary gland pathologies.
- Epilepsy.
- Child receiving drugs that could affect saliva production or other treatments to control drooling just before or during the study.
- Allergic reactions to the kinesio tape.
Trial locations and contacts
1 site in 1 country.
About this study
Statement of the problem :
Which is more effective for treatment of drooling in children with spastic cerebral palsy; kinesio taping or oromotor training?
Null Hypothesis:
There will be no difference between the effectiveness of kinesio taping and oromotor training on drooling in children with spastic cp.
Read the detailed description
Subjects:
The Study targets the children with spastic cerebral palsy from both sexes , sample size estimation will be carried out to determine the recruited number of children ,Children participating in this study will be selected randomly from Cairo pediatric physical therapy centers to participate in this study.
Study Design:
A comparative experimental design (Prospective pre-test post-test design with 2 months follow-up evaluation) .
Children will be assessed by measuring the drooling before and after two months of receiving intervention.
- Conditions
- Drooling, Kinesiotape, Cerebral Palsy
- Being tested
- KINESIOTAPE, oromotor training
- Medical subject headings
- Sialorrhea, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KINESIOTAPEOther
kinesiotape will be applied on orbicularis oris muscle
oromotor trainingOther
selected oromotor training: Perioral sensory stimulation ,Tapping,Tongue pressure,Jaw exercises andIntraoral stimulation
| Study group | Role | What they receive |
|---|---|---|
| groupA(Kinesiotape) | Experimental | kinesio tape on orbicularis oris muscle for 45 minute /3times per week for 2 successive months Receives: Other: KINESIOTAPE |
| group B(oromotor training) | Experimental | oromotor training for 45 minute/ 3 times per week for 2 successive months Receives: Other: oromotor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of drooling severity
by using The 5-minute drooling quotient.it is expressed as a percentage of observed drooling episodes.
Measured: 2 months for each participant
assessment of drooling severity and frequency
by using The Drooling Severity and Frequency Scale. at severity: score 1:no drool ,score5:profuse drooling. at frequency: score 1:never drool ,score4: constant drool
Measured: 2months for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start12 Dec 2021
- Primary completion26 Feb 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DroolingStudies 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
- 2
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Mohamed Awaad, Cairo University
- Investigators
- Hagar Awaad, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524831
- Sponsor's protocol ID
- P.T.REC/012/003677
- Status last verified
- Sep 2022
- First submitted
- 14 Aug 2022
- Last updated
- 14 Sep 2022
- 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 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesio Taping Versus Oromotor Training on Drooling in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05524831
- Acronym / sponsor ID
- P.T.REC/012/003677
- Conditions
- Drooling, Kinesiotape, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 26 Feb 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 1 Sep 2022 (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.
Statement of the problem :
Which is more effective for treatment of drooling in children with spastic cerebral palsy; kinesio taping or oromotor training?
Null Hypothesis:
There will be no difference between the effectiveness of kinesio taping and oromotor training on drooling in children with spastic cp.
Detailed description
Subjects:
The Study targets the children with spastic cerebral palsy from both sexes , sample size estimation will be carried out to determine the recruited number of children ,Children participating in this study will be selected randomly from Cairo pediatric physical therapy centers to participate in this study.
Study Design:
A comparative experimental design (Prospective pre-test post-test design with 2 months follow-up evaluation) .
Children will be assessed by measuring the drooling before and after two months of receiving intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2
| Arm | Type | Receives |
|---|---|---|
| groupA(Kinesiotape) | Experimental | Other: KINESIOTAPEkinesio tape on orbicularis oris muscle for 45 minute /3times per week for 2 successive months |
| group B(oromotor training) | Experimental | Other: oromotor trainingoromotor training for 45 minute/ 3 times per week for 2 successive months |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A diagnosis of spastic cerebral palsy with drooling problem.
- The age of the selected children will range from 4to 8 years old.
- Severe degree of drooling according to Drooling Severity and Frequency Scale.
- Child with good head control
Key exclusion criteria (4 listed)
- Congenital problems of mouth and soft palate such as cleft lip and palate, jaw anomalies and salivary gland pathologies.
- Epilepsy.
- Child receiving drugs that could affect saliva production or other treatments to control drooling just before or during the study.
- Allergic reactions to the kinesio tape.
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 |
|---|---|---|
| KINESIOTAPEkinesiotape will be applied on orbicularis oris muscle | Other | groupA(Kinesiotape) |
| oromotor trainingselected oromotor training: Perioral sensory stimulation ,Tapping,Tongue pressure,Jaw exercises andIntraoral stimulation | Other | group B(oromotor training) |
Primary outcome
assessment of drooling severity
Time frame: 2 months for each participant
by using The 5-minute drooling quotient.it is expressed as a percentage of observed drooling episodes.
assessment of drooling severity and frequency
Time frame: 2months for each participant
by using The Drooling Severity and Frequency Scale. at severity: score 1:no drool ,score5:profuse drooling. at frequency: score 1:never drool ,score4: constant drool
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 14 Sep 2022.
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Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
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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.
Hagar Awaad principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KINESIOTAPE and oromotor training in people with Drooling and Kinesiotape, 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: finished, as of the sponsor's last update on 14 Sep 2022. 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. 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?
assessment of drooling severity (time frame: 2 months for each participant). The study lists 2 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 14 Sep 2022.