The Effect of Trunk Control on Respiratory Muscle Strength
1 other identifier
observational
50
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2016
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 3, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedJuly 11, 2017
July 1, 2017
6 months
July 3, 2017
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
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
- Gazi Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bülent Elbasan
Gazi U
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