Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2019-11-25
2020-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Spastic, dyskinetic or mixed type cerebral palsy
3. GMFCS level 3,4,5
4. Stable drooling within at least one month
Exclusion Criteria
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
4 Years
16 Years
ALL
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Principal Investigators
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Evrim Karadag Saygi, Prof
Role: STUDY_CHAIR
Marmara University
Nida Yektauşakları, PT
Role: PRINCIPAL_INVESTIGATOR
Marmara University School of Health Sciences
Fatma Özer, Student
Role: PRINCIPAL_INVESTIGATOR
Marmara University
Locations
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Esra Giray
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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. doi: 10.1002/(SICI)1097-4547(19981201)54:53.0.CO;2-2.
Other Identifiers
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09.2019.963
Identifier Type: -
Identifier Source: org_study_id
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