Kinesio Taping Versus Oromotor Training on Drooling in Children With Spastic Cerebral Palsy
Primary Purpose
Drooling, Kinesiotape, Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
KINESIOTAPE
oromotor training
Sponsored by
About this trial
This is an interventional treatment trial for Drooling
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Faculty of physical therapy ,cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
groupA(Kinesiotape)
group B(oromotor training)
Arm Description
kinesio tape on orbicularis oris muscle for 45 minute /3times per week for 2 successive months
oromotor training for 45 minute/ 3 times per week for 2 successive months
Outcomes
Primary Outcome Measures
assessment of drooling severity
by using The 5-minute drooling quotient.it is expressed as a percentage of observed drooling episodes.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05524831
Brief Title
Kinesio Taping Versus Oromotor Training on Drooling in Children With Spastic Cerebral Palsy
Official Title
Kinesio Taping Versus Oromotor Training on Drooling in Children With Spastic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 12, 2021 (Actual)
Primary Completion Date
February 26, 2022 (Actual)
Study Completion Date
August 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drooling, Kinesiotape, Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
groupA(Kinesiotape)
Arm Type
Experimental
Arm Description
kinesio tape on orbicularis oris muscle for 45 minute /3times per week for 2 successive months
Arm Title
group B(oromotor training)
Arm Type
Experimental
Arm Description
oromotor training for 45 minute/ 3 times per week for 2 successive months
Intervention Type
Other
Intervention Name(s)
KINESIOTAPE
Intervention Description
kinesiotape will be applied on orbicularis oris muscle
Intervention Type
Other
Intervention Name(s)
oromotor training
Intervention Description
selected oromotor training: Perioral sensory stimulation ,Tapping,Tongue pressure,Jaw exercises andIntraoral stimulation
Primary Outcome Measure Information:
Title
assessment of drooling severity
Description
by using The 5-minute drooling quotient.it is expressed as a percentage of observed drooling episodes.
Time Frame
2 months for each participant
Title
assessment of drooling severity and frequency
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagar Awaad
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy ,cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Kinesio Taping Versus Oromotor Training on Drooling in Children With Spastic Cerebral Palsy
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