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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05524831
Other study ID # P.T.REC/012/003677
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 12, 2021
Est. completion date August 11, 2022

Study information

Verified date September 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 11, 2022
Est. primary completion date February 26, 2022
Accepts healthy volunteers No
Gender All
Age group 4 Years to 8 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
KINESIOTAPE
kinesiotape will be applied on orbicularis oris muscle
oromotor training
selected oromotor training: Perioral sensory stimulation ,Tapping,Tongue pressure,Jaw exercises andIntraoral stimulation

Locations

Country Name City State
Egypt Faculty of physical therapy ,cairo university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary assessment of drooling severity by using The 5-minute drooling quotient.it is expressed as a percentage of observed drooling episodes. 2 months for each participant
Primary 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 2months for each participant
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