NCT03209310

Brief Summary

Cerebral palsy (CP) can be defined as a group of disorders of movement and posture, causing activity limitation that are attributed to nonprogressive deficits that take place in the immature brain. The motor disorders of CP are often accompanied by deficits in sensation, cognition, communication, perception, behavioral and respiratory system . Children with CP have many primary motor impairments such as selective mobility, muscle weakness, abnormal muscle tone, impaired coordination between agonist-antagonist muscles and insufficient postural control. These motor impairments also lead to secondary problems such as contractures and bone deformities. Whether primer or secondary, all these problems can reduce independence in activities of daily living (ADL) by affecting CP children at different levels. There are several studies in children with CP that investigate the effects of trunk control and/or respiratory functions. However, there are very few studies examining the relationship of these functions which have direct effects on ADL. In these studies, the functions of children who are more heavily affected and unable to move have been examined. However, there are no studies examining the effect of trunk control on respiratory muscle strength in children with CP with a better mobility level. There are many factors affecting both trunk control and respiratory functions in these children. Therefore, in children with CP, who have better functional level and can move on their own, revealing the interaction between trunk control and respiratory functions may contribute significantly to the treatment process. For this reason, this study was planned to investigate the effect of trunk control on ADL and respiratory muscle strength in children with CP having a Gross Motor Functional Classification System (GMFCS) levels of 1 and 2 and to compare them with healthy children.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

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

Study Start

First participant enrolled

October 30, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

July 3, 2017

Last Update Submit

July 6, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Trunk Control Measurement Scale (TCMS)

    TCMS measures the state of balance on the support surface and the ability to actively move body parts during functional activities, which are the two components of trunk control. TCMS consists of 15 items in total that are scored on 2, 3 or 4 point ordinal scale and administered bilaterally in case of clinical relevance. The total TCMS score ranges from 0 to 58. A high score on this scale represents a better performance

    15 minutes

Secondary Outcomes (2)

  • Pediatric Evaluation of Disability Inventory (PEDI)

    30 minutes

  • Respiratory Muscle Strength

    15 minutes

Study Arms (2)

The children with Cerebral Palsy

Cerebral palsy (CP) can be defined as a group of disorders of movement and posture, causing activity limitation that are attributed to nonprogressive deficits that take place in the immature brain. The motor disorders of CP are often accompanied by deficits in sensation, cognition, communication, perception, behavioral and respiratory system.

Control Group

Children with typical development were included in this study

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with Cerebral Palsy and healthy volunteers.

You may qualify if:

  • Diagnosis of CP by a pediatric neurologist
  • No significant scoliosis during postural evaluation
  • Were having a level of 1 or 2 of GMFCS
  • No orthopedic surgery or not having Botulinum Toxin-A injection in the last 6 months

You may not qualify if:

  • Having speech or cooperative problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Bülent Elbasan

    Gazi U

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gazi Ethical Committee

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 6, 2017

Study Start

October 30, 2016

Primary Completion

April 16, 2017

Study Completion

July 1, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share