Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Turkish Validation of The Drooling Impact Scale

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132765
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Marmara University

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

Condition or disease Intervention/treatment
Hypersalivation Cerebral Palsy 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reliability and Construct Validity of the Turkish Version of the Drooling Impact Scale Among Children With Cerebral Palsy
Estimated Study Start Date : October 30, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


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
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.

Other: 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)

Other: 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').

Other: 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.

Other: 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)

Other: 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.

Other: number of bibs daily used
Parents will be asked their children's number of bibs daily used.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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').

  3. 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.

  4. 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.

  5. 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.

  6. number of bibs daily used [ Time Frame: Day 0 ]
    Parents will be asked their children's number of bibs daily used.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132765


Contacts
Layout table for location contacts
Contact: Esra Giray, MD +905558134394 girayesra@hotmail.com
Contact: Evrim Karadag-Saygi, Prof +902166570606162 evrimkaradag4@hotmail.com

Locations
Layout table for location information
Turkey
Esra Giray
Istanbul, Turkey, 34899
Sponsors and Collaborators
Marmara University
Investigators
Layout table for investigator information
Study Chair: Evrim Karadag Saygi, Prof Marmara University
Principal Investigator: Nida Yektauşakları, PT Marmara University School of Health Sciences

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT04132765     History of Changes
Other Study ID Numbers: 09.2019.963
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marmara University:
cerebral palsy
drooling impact scale
hypersalivation
validity
Additional relevant MeSH terms:
Layout table for MeSH terms
Sialorrhea
Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases