- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04132765
Turkish Validation of The Drooling Impact Scale
November 25, 2019 updated by: Marmara University
Reliability and Construct Validity of the Turkish Version of the Drooling Impact Scale Among Children With Cerebral Palsy
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
- 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)
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.
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Evrim Karadag-Saygi, Prof
- Phone Number: +902166570606162
- Email: evrimkaradag4@hotmail.com
Study Locations
-
-
-
Istanbul, Turkey, 34899
- Recruiting
- Esra Giray
-
Contact:
- Esra Giray
- Phone Number: 05558134394
- Email: girayesra@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drooling Impact Scale
Time Frame: Day 0
|
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
Time Frame: Day 3
|
A scale with 10 items which are scored with visual analog scale from1 to 10. Drooling impact increases with increased scores.
|
Day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drooling Frequency and Severity Scale
Time Frame: Day 0
|
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
|
The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD™)
Time Frame: Day 0
|
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
|
Drooling Quotient (DQ)
Time Frame: Day 0
|
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
|
Patient and caregiver visual analog scale (VAS) for drooling
Time Frame: Day 0
|
Patients will be asked to score their children's drooling severity on a visual analog scale.
|
Day 0
|
Functional Oral Intake Scale (FOIS)
Time Frame: Day 0
|
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
|
number of bibs daily used
Time Frame: Day 0
|
Parents will be asked their children's number of bibs daily used.
|
Day 0
|
number of hospital admissions per year related to respiratory infections
Time Frame: Day 0
|
Parents will be asked their children's number of hospital admissions per year related to respiratory infections.
|
Day 0
|
Gross Motor Function Classification System (GMFCS)
Time Frame: Day 0
|
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
|
Manual Ability Classification System (MACS)
Time Frame: Day 0
|
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
|
Communication Function Classification System (CFCS)
Time Frame: Day 0
|
The CFCS is a simple, five-point ordinal classification system that assesses everyday communication (not optimal communication) of children with cerebral palsy.
|
Day 0
|
Eating and Drinking Ability Classification System (EDACS)
Time Frame: Day 0
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nida Yektauşakları, PT, Marmara University School of Health Sciences
- Principal Investigator: Fatma Özer, Student, Marmara University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 25, 2019
Primary Completion (Anticipated)
August 30, 2020
Study Completion (Anticipated)
August 30, 2020
Study Registration Dates
First Submitted
October 17, 2019
First Submitted That Met QC Criteria
October 17, 2019
First Posted (Actual)
October 21, 2019
Study Record Updates
Last Update Posted (Actual)
November 27, 2019
Last Update Submitted That Met QC Criteria
November 25, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2019.963
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on Drooling Impact Scale
-
Hacettepe UniversityCompleted
-
Hospices Civils de LyonCompletedPost Traumatic Stress DisorderFrance
-
Memorial Sloan Kettering Cancer CenterRecruitingEndometrial CancerUnited States
-
Uskudar State HospitalSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey; Basaksehir...Not yet recruiting
-
Kanuni Sultan Suleyman Training and Research HospitalCompleted
-
Nantes University HospitalTerminated
-
Konya Beyhekim Training and Research HospitalCompleted
-
Leiden University Medical CenterRecruitingUveal MelanomaNetherlands
-
Maharishi Markendeswar University (Deemed to be...Completed
-
University of ChicagoActive, not recruitingCovid-19 | Critical Illness | Respiratory Failure | Corona Virus InfectionUnited States