Posture Disorders in ChildrenNCT04409730
Photographic Posture Analysis in Children With Cerebral Palsy
A study testing Photographic Posture Analysis in people with Posture Disorders in Children and Cerebral Palsy, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP), which is the largest group of patients among pediatric neuromuscular diseases, is a non-progressive permanent disorder that affects muscle control, movement, posture and balance. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Posture Disorders in Children, Cerebral Palsy
- What is being tested?
- Photographic Posture Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Mar 2020
- Phase
- Interventional
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 5-12 years,
- Diagnosed as spastic diplegia or hemiplegia,
- Having a level of "I, II, III" according to GMFCS
Who cannot join
- Children who could not cooperate,
- Have undergone spinal surgery, had botulinum toxin (BoNT) and surgical treatment in the last 6 months
- Had another neurodevelopmental or congenital disease other than CP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Photographic Posture Analysis in Children With Cerebral Palsy and Its Relationship With Trunk Control and Motor Functions
Cerebral palsy (CP), which is the largest group of patients among pediatric neuromuscular diseases, is a non-progressive permanent disorder that affects muscle control, movement, posture and balance. The purpose of this study; to evaluate the reliability of photographic posture analysis in the sitting position in children with CP and to examine the relationship between the results of photographic posture analysis with the motor performances and trunk control of children with CP.Children with CP were included in the study according to the following criteria; aged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a level of "I, II, III" according to GMFCS. Postural evaluation was done using the photographic method. Trunk control was evaluated with Trunk Control Measurement Scale,Motor performance of children was evaluated with Gross Motor Function Measure-88. ICC values for photographic posture analysis was found to be highly reliable.
Read the detailed description
Sitting position is of great importance in the development of upper extremity functions, orthogonal functional skills, personal care, cognitive, perceptual and social skills in children with cerebral palsy and these kids spend most of their time in a sitting position.There are goniometer, inclinometer, flexicurve, spinal mouse, and modified head posture spinal curvature ınstrument tools for posture analysis in the sitting position.However, none of these measurement tools have been validated for validity and reliability studies of head and trunk posture measurement in the sitting position in children with CP. Methods such as magnetic resonance (MR) and x-ray used in posture evaluation provide clear images of reference points and are the gold standard in the literature. However, they are not preferred much because they are expensive and contain radiation.Photographic posture analysis can be considered as a measurement method such as posture analysis methods using the gravity line. It is a digital, more objective measurement method that measures linear distances and angles using anatomical reference points using specially designed software. Clinical use of photographic posture analysis is recommended in the literature, as it is an accurate and objective method, preventing radiation exposure.The purpose of this study; to evaluate the reliability of photographic posture analysis in the sitting position in children with CP and to examine the relationship between the results of photographic posture analysis with the motor performances and trunk control of children with CP.
- Conditions
- Posture Disorders in Children, Cerebral Palsy
- Being tested
- Photographic Posture Analysis
- Keywords
- trunk, posture analysis, cerebral palsy, performance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photographic Posture AnalysisOther
Postural evaluation was done using the photographic method. All measurements were made by two researchers experienced in postural analysis evaluation. Canon camera and national geographic tripod with double spirit level were used for evaluation. The camera was placed on a 115 cm high tripod, 1.5 m away from the subjects. Spirit levels have been adjusted so that the tripod is completely flat on the ground. The tripod was taped to the floor to maintain the same distance between the camera and the participants. Six photographs of each child whose feet on the ground, in a free-sitting position, 3 from the front and 3 sides were taken by the researchers.
| Study group | Role | What they receive |
|---|---|---|
| Children with Cerebral Palsy | Experimental | Aged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a level of "I, II, III" according to GMFCS Receives: Other: Photographic Posture Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic Posture Analysis
Postural evaluation was done using the photographic method. All measurements were made by two researchers experienced in postural analysis evaluation. Canon camera and national geographic tripod with double spirit level were used for evaluation Six photographs of each child whose feet on the ground, in a free-sitting position, 3 from the front and 3 sides were taken by the researchers
Measured: 45-60 minutes
Secondary outcomes (2)
Trunk Control Measurement Scale (TCMS)
Trunk control was evaluated with Trunk Control Measurement Scale is a scale that measures the static and dynamic sitting balance in children with CP. It consists of 15 items in total, 1-5 items measure Static Sitting Balance, 6-15 items measure dynamic sitting balance. Static sitting balance assesses the ability of children to maintain the trunk posture as they move their upper and lower limbs in the sitting posture. Dynamic sitting balance is divided into two sub-scales; selective motion control scale and dynamic reach scale. The maximum score that can be obtained from the test is 58. Higher scores perform better.
Measured: 30-40 minutes
Gross Motor Function Measure-88 (GMFM-88)
GMFM-88 is a standardized observational test designed to measure the motor development levels of children with SP and their changes over time. It consists of five main headings and 88 items: lying and rolling; sitting; crawling and kneeling; standing; walking, running, and jumping. 17 of the 88 items are on the lying and rolling part, 20 on the sitting part, 14 on the crawling and kneeling part, 13 on the standing part, and 24 on the walking, running, and jumping part. Likert scale is used in scoring. The child gets 0 points if he / she cannot start the movement, 1 if he / she can start the movement independently, 2 if he / she can partially complete the movement, and 3 if he / she can complete the movement independently. A 5-year-old child with normal development is expected to score full of 88 items. The GMFM-88 was administered to the children by therapists trained in its use and tested to ensure an adequate level of competence by using a criterion test videotape
Measured: 30-45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Mar 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posture Disorders in ChildrenStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Comuk Balci, Baskent University
- Investigators
- Nilay Çömük Balcı, Pt,PhD, Study director, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409730
- Sponsor's protocol ID
- KA19/126
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Photographic Posture Analysis in Children With Cerebral Palsy and Its Relationship With Trunk Control and Motor Functions
- ClinicalTrials.gov ID
- NCT04409730
- Acronym / sponsor ID
- KA19/126
- Conditions
- Posture Disorders in Children, Cerebral Palsy
- Keywords
- trunk, posture analysis, cerebral palsy, performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 1 Jun 2020 (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), which is the largest group of patients among pediatric neuromuscular diseases, is a non-progressive permanent disorder that affects muscle control, movement, posture and balance. The purpose of this study; to evaluate the reliability of photographic posture analysis in the sitting position in children with CP and to examine the relationship between the results of photographic posture analysis with the motor performances and trunk control of children with CP.Children with CP were included in the study according to the following criteria; aged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a level of "I, II, III" according to GMFCS. Postural evaluation was done using the photographic method. Trunk control was evaluated with Trunk Control Measurement Scale,Motor performance of children was evaluated with Gross Motor Function Measure-88. ICC values for photographic posture analysis was found to be highly reliable.
Detailed description
Sitting position is of great importance in the development of upper extremity functions, orthogonal functional skills, personal care, cognitive, perceptual and social skills in children with cerebral palsy and these kids spend most of their time in a sitting position.There are goniometer, inclinometer, flexicurve, spinal mouse, and modified head posture spinal curvature ınstrument tools for posture analysis in the sitting position.However, none of these measurement tools have been validated for validity and reliability studies of head and trunk posture measurement in the sitting position in children with CP. Methods such as magnetic resonance (MR) and x-ray used in posture evaluation provide clear images of reference points and are the gold standard in the literature. However, they are not preferred much because they are expensive and contain radiation.Photographic posture analysis can be considered as a measurement method such as posture analysis methods using the gravity line. It is a digital, more objective measurement method that measures linear distances and angles using anatomical reference points using specially designed software. Clinical use of photographic posture analysis is recommended in the literature, as it is an accurate and objective method, preventing radiation exposure.The purpose of this study; to evaluate the reliability of photographic posture analysis in the sitting position in children with CP and to examine the relationship between the results of photographic posture analysis with the motor performances and trunk control of children with CP.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Cerebral Palsy | Experimental | Other: Photographic Posture AnalysisAged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a level of "I, II, III" according to GMFCS |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 5-12 years,
- Diagnosed as spastic diplegia or hemiplegia,
- Having a level of "I, II, III" according to GMFCS
Key exclusion criteria (3 listed)
- Children who could not cooperate,
- Have undergone spinal surgery, had botulinum toxin (BoNT) and surgical treatment in the last 6 months
- Had another neurodevelopmental or congenital disease other than CP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photographic Posture AnalysisPostural evaluation was done using the photographic method. All measurements were made by two researchers experienced in postural analysis evaluation. Canon camera and national geographic tripod with double spirit level were used for evaluation. The camera was placed on a 115 cm high tripod, 1.5 m away from the subjects. Spirit levels have been adjusted so that the tripod is completely flat on the ground. The tripod was taped to the floor to maintain the same distance between the camera and the participants. Six photographs of each child whose feet on the ground, in a free-sitting position, 3 from the front and 3 sides were taken by the researchers. | Other | Children with Cerebral Palsy |
Primary outcome
Photographic Posture Analysis
Time frame: 45-60 minutes
Postural evaluation was done using the photographic method. All measurements were made by two researchers experienced in postural analysis evaluation. Canon camera and national geographic tripod with double spirit level were used for evaluation Six photographs of each child whose feet on the ground, in a free-sitting position, 3 from the front and 3 sides were taken by the researchers
2 secondary outcomes
Trunk Control Measurement Scale (TCMS)
Time frame: 30-40 minutes
Gross Motor Function Measure-88 (GMFM-88)
Time frame: 30-45 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 1 Jun 2020.
- 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.
Nilay Çömük Balcı, Pt,PhD study director
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photographic Posture Analysis in people with Posture Disorders in Children and Cerebral Palsy, run by Baskent University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Photographic Posture Analysis (time frame: 45-60 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 1 Jun 2020.