Cerebral Palsy, SpasticNCT03209310
The Effect of Trunk Control on Respiratory Muscle Strength
An observational study of Cerebral Palsy, Spastic and Posture, run by Gazi University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Spastic, Posture, Respiratory Muscle Strength
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2016to 1 Jul 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with Cerebral Palsy and healthy volunteers.
Who may be able to join
- 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
Who cannot join
- Having speech or cooperative problems
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 minutes
Secondary outcomes (2)
Pediatric Evaluation of Disability Inventory (PEDI)
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.
Measured: 30 minutes
Respiratory Muscle Strength
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start30 Oct 2016
- Primary completion16 Apr 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Gazi 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.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Apaydin, Gazi University
- Investigators
- Bülent Elbasan, Study chair, Gazi U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209310
- Sponsor's protocol ID
- B.10.4.ISM.4.06.68.49/975
- Status last verified
- Jul 2017
- First submitted
- 3 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Trunk Control on Respiratory Muscle Strength and Activities of Daily Living in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03209310
- Acronym / sponsor ID
- B.10.4.ISM.4.06.68.49/975
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 30 Oct 2016 (actual)
- Primary completion
- 16 Apr 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with Cerebral Palsy and healthy volunteers.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Having speech or cooperative problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: 30 minutes
Respiratory Muscle Strength
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bülent Elbasan study chair
Gazi U
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, Spastic and Posture, run by Gazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Control Measurement Scale (TCMS) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.