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CompletedNCT05524831Updated Sep 14, 2022

Kinesio Taping Versus Oromotor Training on Drooling in Children With Spastic Cerebral Palsy

An interventional study of KINESIOTAPE and oromotor training in Drooling, Kinesiotape and Cerebral Palsy, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2022-09-14.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Dec 2021, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
4 Years to 8 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Drooling
  • Kinesiotape
  • Cerebral Palsy
03

In context

Sialorrhea

60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.

This study's enrollment of 30 is close to the median of 31 across 44 interventional studies indexed under Sialorrhea.

Browse Sialorrhea studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. A diagnosis of spastic cerebral palsy with drooling problem.
  2. The age of the selected children will range from 4to 8 years old.
  3. Severe degree of drooling according to Drooling Severity and Frequency Scale.
  4. Child with good head control

Exclusion criteria

Exclusion Criteria:

  1. Congenital problems of mouth and soft palate such as cleft lip and palate, jaw anomalies and salivary gland pathologies.
  2. Epilepsy.
  3. Child receiving drugs that could affect saliva production or other treatments to control drooling just before or during the study.
  4. Allergic reactions to the kinesio tape.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    groupA(Kinesiotape)

    kinesio tape on orbicularis oris muscle for 45 minute /3times per week for 2 successive months

    Other: KINESIOTAPE

  • Experimental
    group B(oromotor training)

    oromotor training for 45 minute/ 3 times per week for 2 successive months

    Other: oromotor training

Interventions

  • OtherKINESIOTAPE

    kinesiotape will be applied on orbicularis oris muscle

  • Otheroromotor training

    selected oromotor training: Perioral sensory stimulation ,Tapping,Tongue pressure,Jaw exercises andIntraoral stimulation

06

What researchers measure

Primary outcomes

  1. assessment of drooling severity

    by using The 5-minute drooling quotient.it is expressed as a percentage of observed drooling episodes.

    Time frame: 2 months for each participant

  2. 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

    Time frame: 2months for each participant

07

Study locations

1 site
  • Faculty of physical therapy ,cairo university
    Cairo, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2021 to primary completion in Feb 2022, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2022
First posted
Sep 1, 2022
StartActual
Dec 12, 2021
Primary completionActual
Feb 26, 2022
CompletionActual
Aug 11, 2022
Last update
Sep 14, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05524831
Lead sponsor
Cairo University
Responsible party
Hagar Mohamed Awaad (Scientific researcher, Cairo University) — Principal investigator
First posted
Sep 1, 2022
Start date
Dec 12, 2021
Primary completion
Feb 26, 2022
Completion
Aug 11, 2022
Last update
Sep 14, 2022

Study contacts

Hagar Awaad
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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