An observational study in Hypersalivation and Cerebral Palsy, sponsored by Marmara University. Status unknown at 1 site in Turkey. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Marmara University · Observational
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
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.
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This study's planned enrollment of 30 is below the median of 90 across 11 observational studies indexed under Sialorrhea.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with cerebral palsy at between the ages of 4-16 years and at Gross Motor Function Classification Levels of 3,4,5
Other: Drooling Impact Scale · Other: Drooling Frequency and Severity Scale · Other: The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD™) · Other: Drooling Quotient (DQ) · Other: Patient and caregiver visual analog scale (VAS) for drooling · Other: Functional Oral Intake Scale (FOIS) · Other: number of bibs daily used · Other: number of hospital admissions per year related to respiratory infections · Other: Gross Motor Function Classification System (GMFCS) · Other: Manual Ability Classification System (MACS) · Other: Communication Function Classification System (CFCS) · Other: Eating and Drinking Ability Classification System (EDACS)
A scale with 10 items which are scored with visual analog scale from1 to 10. Drooling impact increases with increased scores.
In this scale, parents or care givers were asked to rate the severity and frequency of drooling, classifying severity of drooling using a 5-level domain ranging from 1 (dry) to 5 (profuse drooling). The frequency of drooling was classified using a 4-level domain ranging from 1(no drooling) to 4 (constant drooling)
A quality of life scale that measure caregivers' perspectives on the health status, comfort, well being, and ease of caregiving of children with severe developmental disabilities. CPCHILD consists of 36 items distributed over six sections representing the following domains: (1) Personal Care (eight items); (2) Positioning, Transfer, and Mobility (eight items); (3) Communication and Social Interaction (seven items); (4) Comfort, Emotions, and Behaviour (nine items); (5) Health (three items); and (6) Overall Quality Of Life (one item). For the sections which involve the performance of skills, the degree of difficulty of accomplishing each task or activity was rated on a 7-point ordinal scale anchored by 0 ('No problem at all') to 6 ('Impossible').
DQ is a semi-quantitative method that assesses the presence of newly formed saliva on the lips every 15 seconds with 40 observations in 10 minutes, expressed as a percentage based on the ratio between the number of observed drooling episodes and the total number of observations.
Patients will be asked to score their children's drooling severity on a visual analog scale (0-100 mm, 0 none to 100 severe)
Functional Oral Intake Scale (FOIS) which is a 7-point ordinal scale document the functional level of oral intake of food and liquid.
Parents will be asked their children's number of bibs daily used.
Parents will be asked their children's number of hospital admissions per year related to respiratory infections.
The GMFCS describes self-initiated movement and use of assistive devices (walkers, crutches, canes, wheelchairs) for mobility during an individual's usual activity.
The MACS is also a simple, five-point ordinal classification system and was designed for use in children ages 4-18 years. The MACS is a validated measure in cerebral palsy that can be used to classify a child's typical use of both hands and upper limbs.
The CFCS is a simple, five-point ordinal classification system that assesses everyday communication (not optimal communication) of children with cerebral palsy.
EDACS is a measure to assess eating and drinking ability for children with CP, ages 3 and older. This classification is a simple five-point ordinal system.
Drooling Impact Scale
A scale with 10 items which are scored with visual analog scale from1 to 10. Drooling impact increases with increased scores.
Time frame: Day 0
Drooling Impact Scale
A scale with 10 items which are scored with visual analog scale from1 to 10. Drooling impact increases with increased scores.
Time frame: Day 3
Drooling Frequency and Severity Scale
n this scale, parents or care givers were asked to rate the severity and frequency of drooling, classifying severity of drooling using a 5-level domain ranging from 1 (dry) to 5 (profuse drooling). The frequency of drooling was classified using a 4-level domain ranging from 1(no drooling) to 4 (constant drooling)
Time frame: Day 0
The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD™)
A quality of life scale that measure caregivers' perspectives on the health status, comfort, well being, and ease of caregiving of children with severe developmental disabilities. CPCHILD consists of 36 items distributed over six sections representing the following domains: (1) Personal Care (eight items); (2) Positioning, Transfer, and Mobility (eight items); (3) Communication and Social Interaction (seven items); (4) Comfort, Emotions, and Behaviour (nine items); (5) Health (three items); and (6) Overall Quality Of Life (one item). For the sections which involve the performance of skills, the degree of difficulty of accomplishing each task or activity was rated on a 7-point ordinal scale anchored by 0 ('No problem at all') to 6 ('Impossible').
Time frame: Day 0
Drooling Quotient (DQ)
DQ is a semi-quantitative method that assesses the presence of newly formed saliva on the lips every 15 seconds with 40 observations in 10 minutes, expressed as a percentage based on the ratio between the number of observed drooling episodes and the total number of observations.
Time frame: Day 0
Patient and caregiver visual analog scale (VAS) for drooling
Patients will be asked to score their children's drooling severity on a visual analog scale.
Time frame: Day 0
Functional Oral Intake Scale (FOIS)
Functional Oral Intake Scale (FOIS) which is a 7-point ordinal scale document the functional level of oral intake of food and liquid.
Time frame: Day 0
number of bibs daily used
Parents will be asked their children's number of bibs daily used.
Time frame: Day 0
number of hospital admissions per year related to respiratory infections
Parents will be asked their children's number of hospital admissions per year related to respiratory infections.
Time frame: Day 0
Gross Motor Function Classification System (GMFCS)
The GMFCS describes self-initiated movement and use of assistive devices (walkers, crutches, canes, wheelchairs) for mobility during an individual's usual activity.
Time frame: Day 0
Manual Ability Classification System (MACS)
The MACS is also a simple, five-point ordinal classification system and was designed for use in children ages 4-18 years. The MACS is a validated measure in cerebral palsy that can be used to classify a child's typical use of both hands and upper limbs.
Time frame: Day 0
Communication Function Classification System (CFCS)
The CFCS is a simple, five-point ordinal classification system that assesses everyday communication (not optimal communication) of children with cerebral palsy.
Time frame: Day 0
Eating and Drinking Ability Classification System (EDACS)
EDACS is a measure to assess eating and drinking ability for children with CP, ages 3 and older. This classification is a simple five-point ordinal system.
Time frame: Day 0
Plan to share: No — The data that support the findings of this study will be available on request from the corresponding author (EG). The data will not be publicly available due to their containing information that could compromise the privacy of research participants.
Started Nov 2019 (actual). Primary completion is estimated for Aug 2020, 9 months after the start.
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This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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