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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drooling

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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:

  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.

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

First Posted
August 14, 2022
Last Updated
September 11, 2022
Sponsor
Cairo University
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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

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

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