NCT03241160

Brief Summary

The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

August 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1 month

First QC Date

August 2, 2017

Last Update Submit

September 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chewing evaluation

    Chewing evaluation will be determined by a scale that classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.

    15 days

Secondary Outcomes (2)

  • Gross motor function evaluation

    15 days

  • Trunk control evaluation

    15 days

Study Arms (1)

Children with cerebral palsy

Children with a diagnosis of spastic cerebral palsy aged between 2 to 12 years who will be referred by pediatric neurologists will be included. Children under the age of 24 months, and used any medicine and/or oral appliances that could affect the chewing performance, will be excluded. Chewing evaluation will be performed.

Other: Chewing evaluation

Interventions

Chewing evaluation will be performed. An experienced physical therapist who will take a scale training session will do the chewing evaluation according to the chewing performance scale.This scale classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.

Children with cerebral palsy

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with a diagnosis of spastic cerebral palsy

You may qualify if:

  • Having a diagnosis of cerebral palsy
  • Referring by a pediatric neurologist
  • Aging between 2 to 12 years

You may not qualify if:

  • Aging under the age of 24 months
  • Using any medicine and/or oral appliances that could affect the chewing performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacetttepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Serel Arslan S, Demir N, Inal O, Karaduman AA. The severity of chewing disorders is related to gross motor function and trunk control in children with cerebral palsy. Somatosens Mot Res. 2018 Sep-Dec;35(3-4):178-182. doi: 10.1080/08990220.2018.1521788. Epub 2018 Dec 28.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • SELEN SEREL ARSLAN

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 7, 2017

Study Start

August 5, 2017

Primary Completion

September 8, 2017

Study Completion

September 8, 2017

Last Updated

September 11, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations