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Turkish Validation of The Drooling Impact Scale

M

Marmara University

Status

Unknown

Conditions

Hypersalivation
Cerebral Palsy

Treatments

Other: number of hospital admissions per year related to respiratory infections
Other: Gross Motor Function Classification System (GMFCS)
Other: Drooling Quotient (DQ)
Other: Drooling Impact Scale
Other: Manual Ability Classification System (MACS)
Other: Communication Function Classification System (CFCS)
Other: Functional Oral Intake Scale (FOIS)
Other: Eating and Drinking Ability Classification System (EDACS)
Other: Patient and caregiver visual analog scale (VAS) for drooling
Other: Drooling Frequency and Severity Scale
Other: The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD™)
Other: number of bibs daily used

Study type

Observational

Funder types

Other

Identifiers

NCT04132765
09.2019.963

Details and patient eligibility

About

The aim of this study is to investigate the reliability and construct validity of the Turkish version of the Drooling Impact Scale in children with cerebral palsy

Full description

Drooling is common among several neurologic disorders such as cerebral palsy, Parkinson's disease, amyotrophic lateral sclerosis, which are the main diseases that physiatrist are one of the leading physicians involved in whose management 1. Drooling can be seen either as anterior drooling, unintentional leaving of saliva from mouth to outside of the body, or posterior drooling, invisible spill of saliva from mouth through pharyngeal isthmus and then to respiratory or digestive tract, inside the body 2. Anterior drooling causes psycho-social impairment, skin problems, infections, bad odor, dehydration, dentation problems and wet clothes and tools while posterior drooling may result in morbidity by posing a risk for aspiration pneumonia. Despite the frequency and significance of the condition, there is still a paucity of research and inadequate evidence about the various treatments and valid and reliable outcomes available. A major problem for research into interventions to reduce drooling is that there is no valid and reliable measurement tool of saliva control. There is no questionnaire in Turkish to evaluate the effects of drooling as well as drooling interventions.The aim of this study is to investigate the reliability and construct validity of the Turkish version of the Drooling Impact Scale in children with cerebral palsy.

Enrollment

30 estimated patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients with unilateral or bilateral cerebral palsy at between the ages of 4-16
  2. Spastic, dyskinetic or mixed type cerebral palsy
  3. GMFCS level 3,4,5
  4. Stable drooling within at least one month

Exclusion criteria

  1. Active infection of salivary glands
  2. Upper respiratory tract infection at the time of testing
  3. History of anticholinergic drug intake in the past three weeks
  4. Occurance of any above between test and re-test assessment that may interfere with the results

Trial design

30 participants in 1 patient group

Patients with cerebral palsy
Description:
Patients with cerebral palsy at between the ages of 4-16 years and at Gross Motor Function Classification Levels of 3,4,5
Treatment:
Other: Eating and Drinking Ability Classification System (EDACS)
Other: Patient and caregiver visual analog scale (VAS) for drooling
Other: Drooling Impact Scale
Other: The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD™)
Other: Communication Function Classification System (CFCS)
Other: Drooling Frequency and Severity Scale
Other: Drooling Quotient (DQ)
Other: number of bibs daily used
Other: Manual Ability Classification System (MACS)
Other: Functional Oral Intake Scale (FOIS)
Other: number of hospital admissions per year related to respiratory infections
Other: Gross Motor Function Classification System (GMFCS)

Trial contacts and locations

1

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Central trial contact

Esra Giray, MD; Evrim Karadag-Saygi, Prof

Data sourced from clinicaltrials.gov

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