The Effect of Trunk Control on Respiratory Muscle Strength

July 6, 2017 updated by: Umut Apaydin, Gazi University

The Effect of Trunk Control on Respiratory Muscle Strength and Activities of Daily Living in 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 .

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Trunk control was evaluated by Trunk Control Measurement Scale (TCMS), ADL was evaluated by Pediatric Evaluation of Disability Inventory (PEDI) and respiratory muscle strength was evaluated by mouth pressure meter.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with Cerebral Palsy and healthy volunteers.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Having speech or cooperative problems

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Trunk Control Measurement Scale (TCMS)
Time Frame: 15 minutes
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame: 30 minutes
The ADLs of the children participating in the study were assessed by the Pediatric Evaluation of Disability Inventory (PEDI). It is a clinical measurement developed by Haley and used to evaluate the change in the functional skills, functional abilities and performance of children with disabilities. PEDI consists of two sections as Functional Skills Scale and Caregiver Assistance Scale. The first section, the Functional Skills Scale, is divided into three subscales: self-care, mobility and social function. This section, which consists of 197 items in total, is scored as unable (0) and capable (1). The second section of PEDI, the Caregiver Assistance Scale, is also divided into three subscales: self-care, mobility and social function. It consists of 20 items in total. Each item in this section is scored between 0 and 5. A score of 5 indicates that the child is completely independent, while a score of 0 indicates that the child is completely dependent on the caregiver.
30 minutes
Respiratory Muscle Strength
Time Frame: 15 minutes
These measurements were made using the respiratory pressure meter (Micro Medical Micro RPM, UK) and performed according to American Thoracic Society/European Respiratory Society criteria (ATS. and ERS. 2002). Maximal Inspiratory Pressure (MIP) was measured in the residual volume after maximal expiration, while Maximal Expiratory Pressure (MEP) was measured in total lung capacity after maximum inspiration.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bülent Elbasan, Gazi U

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B.10.4.ISM.4.06.68.49/975

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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