Turkish Validation of The Drooling Impact Scale
Reliability and Construct Validity of the Turkish Version of the Drooling Impact Scale Among Children With Cerebral Palsy
1 other identifier
observational
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2019
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
October 17, 2019
CompletedFirst Posted
Study publicly available on registry
October 21, 2019
CompletedStudy Start
First participant enrolled
November 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2020
CompletedNovember 27, 2019
October 1, 2019
9 months
October 17, 2019
November 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Drooling Impact Scale
A scale with 10 items which are scored with visual analog scale from1 to 10. Drooling impact increases with increased scores.
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.
Day 3
Secondary Outcomes (11)
Drooling Frequency and Severity Scale
Day 0
The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD™)
Day 0
Drooling Quotient (DQ)
Day 0
Patient and caregiver visual analog scale (VAS) for drooling
Day 0
Functional Oral Intake Scale (FOIS)
Day 0
- +6 more secondary outcomes
Study Arms (1)
Patients with cerebral palsy
Patients with cerebral palsy at between the ages of 4-16 years and at Gross Motor Function Classification Levels of 3,4,5
Interventions
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.
Eligibility Criteria
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
You may qualify if:
- Patients with unilateral or bilateral cerebral palsy at between the ages of 4-16
- Spastic, dyskinetic or mixed type cerebral palsy
- GMFCS level 3,4,5
- Stable drooling within at least one month
You may not qualify if:
- Active infection of salivary glands
- Upper respiratory tract infection at the time of testing
- History of anticholinergic drug intake in the past three weeks
- Occurance of any above between test and re-test assessment that may interfere with the results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Esra Giray
Istanbul, 34899, Turkey (Türkiye)
Related Publications (3)
Lakraj AA, Moghimi N, Jabbari B. Sialorrhea: anatomy, pathophysiology and treatment with emphasis on the role of botulinum toxins. Toxins (Basel). 2013 May 21;5(5):1010-31. doi: 10.3390/toxins5051010.
PMID: 23698357RESULTErasmus 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.
PMID: 21932013RESULTPesheva P, Kuklinski S, Schmitz B, Probstmeier R. Galectin-3 promotes neural cell adhesion and neurite growth. J Neurosci Res. 1998 Dec 1;54(5):639-54. doi: 10.1002/(SICI)1097-4547(19981201)54:53.0.CO;2-2.
PMID: 9843155RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Evrim Karadag Saygi, Prof
Marmara University
- PRINCIPAL INVESTIGATOR
Nida Yektauşakları, PT
Marmara University School of Health Sciences
- PRINCIPAL INVESTIGATOR
Fatma Özer, Student
Marmara University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2019
First Posted
October 21, 2019
Study Start
November 25, 2019
Primary Completion
August 30, 2020
Study Completion
August 30, 2020
Last Updated
November 27, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
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.