Turkish Validation of The Drooling Impact Scale

Cerebral Palsy Clinical Trial

Official title:

Reliability and Construct Validity of the Turkish Version of the Drooling Impact Scale Among Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04132765
• Other study ID #: 09.2019.963
• Status: Recruiting
• Start date: November 25, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: October 2019
• Source: Marmara University
• Contact: Esra Giray, MD
• Phone: +905558134394
• Email: girayesra[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hypersalivation
• Sialorrhea

Intervention

Other:
• Drooling Impact Scale
A scale with 10 items which are scored with visual analog scale from1 to 10. Drooling impact increases with increased scores.
• Drooling Frequency and Severity Scale
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)
• 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').
• 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.
• 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 (0-100 mm, 0 none to 100 severe)
• 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.
• number of bibs daily used
Parents will be asked their children's number of bibs daily used.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Esra Giray	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

Pesheva 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)	Day 0
Secondary	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').	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	number of bibs daily used	Parents will be asked their children's number of bibs daily used.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0

External Links

•   Sialorrhea: A Guide to Etiology, Assessment, and Management