Turkish Validation of The Drooling Impact Scale

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 4 to 16 years
• All sexes
• No healthy volunteers
• Child

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

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Hypersalivation, Cerebral Palsy

Being tested

Drooling Impact Scale, Drooling Frequency and Severity Scale, The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD™), Drooling Quotient (DQ), Patient and caregiver visual analog scale (VAS) for drooling

Keywords

cerebral palsy, drooling impact scale, hypersalivation, validity

Medical subject headings

Sialorrhea, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Drooling Impact ScaleOther

  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 ScaleOther

  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™)Other

  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)Other

  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 droolingOther

  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)Other

  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 usedOther

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

• number of hospital admissions per year related to respiratory infectionsOther

  Parents will be asked their children's number of hospital admissions per year related to respiratory infections.

• Gross Motor Function Classification System (GMFCS)Other

  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)Other

  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)Other

  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)Other

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. Drooling Impact Scale

   A scale with 10 items which are scored with visual analog scale from1 to 10. Drooling impact increases with increased scores.

   Measured: Day 0

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.

   Measured: Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted21 Oct 2019
2. Study start25 Nov 2019
3. Primary completion30 Aug 2020 (estimated)
4. Study completion30 Aug 2020 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (3)Papers the sponsor has linked to this study.
• Other trials for HypersalivationStudies of the same condition, open and under way.
• More trials run by Marmara UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.