NCT05524831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

August 14, 2022

Last Update Submit

September 11, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

groupA(Kinesiotape)

EXPERIMENTAL

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

Other: KINESIOTAPE

group B(oromotor training)

EXPERIMENTAL

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

Other: oromotor training

Interventions

kinesiotape will be applied on orbicularis oris muscle

groupA(Kinesiotape)

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

group B(oromotor training)

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy ,cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

SialorrheaCerebral Palsy

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Hagar Awaad

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific researcher

Study Record Dates

First Submitted

August 14, 2022

First Posted

September 1, 2022

Study Start

December 12, 2021

Primary Completion

February 26, 2022

Study Completion

August 11, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations