Clinical trial NCT04132765: Turkish Validation of The Drooling Impact Scale
Official title: Reliability and Construct Validity of the Turkish Version of the Drooling Impact Scale Among Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypersalivation
Cerebral Palsy
Keywords: cerebral palsy
drooling impact scale
hypersalivation
validity
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with unilateral or bilateral, spastic, dyskinetic or mixed type cerebral palsy at between the ages of 4-16 and GMFCS level 3,4,5

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Drooling Impact Scale
timeFrame: Day 0
measure: Drooling Impact Scale
timeFrame: Day 3
Secondary outcomes:
measure: Drooling Frequency and Severity Scale
timeFrame: Day 0
measure: The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD™)
timeFrame: Day 0
measure: Drooling Quotient (DQ)
timeFrame: Day 0
measure: Patient and caregiver visual analog scale (VAS) for drooling
timeFrame: Day 0
measure: Functional Oral Intake Scale (FOIS)
timeFrame: Day 0
measure: number of bibs daily used
timeFrame: Day 0
measure: number of hospital admissions per year related to respiratory infections
timeFrame: Day 0
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: Day 0
measure: Manual Ability Classification System (MACS)
timeFrame: Day 0
measure: Communication Function Classification System (CFCS)
timeFrame: Day 0
measure: Eating and Drinking Ability Classification System (EDACS)
timeFrame: Day 0
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Esra Giray
Study officials:
affiliation: Marmara University
name: Evrim Karadag Saygi, Prof
role: STUDY_CHAIR
affiliation: Marmara University School of Health Sciences
name: Nida Yektauşakları, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Fatma Özer, Student
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Erasmus CE, van Hulst K, Rotteveel JJ, Willemsen MA, Jongerius PH. Clinical practice: swallowing problems in cerebral palsy. Eur J Pediatr. 2012 Mar;171(3):409-14. doi: 10.1007/s00431-011-1570-y. Epub 2011 Sep 20.
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